Lung Non-Small Cell CarcinomaPhase 3NCT04267848
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
A Phase 3 study testing Biospecimen Collection, Carboplatin and Cisplatin in people with Lung Non-Small Cell Carcinoma and Lung Non-Small Cell Squamous Carcinoma, run by National Cancer Institute (NCI) at 1,151 sites in 2 countries.
Trial summary
This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma, Lung Non-Squamous Non-Small Cell Carcinoma
- What is being tested?
- Biospecimen Collection, Carboplatin and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,210 participants
- Where
- 1,151 sitesin 2 countries
- Study dates
- 16 Jun 2020to 31 Jan 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A female of childbearing potential is a sexually mature female who:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
- Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)
- Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263
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- Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017
- Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population
- Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery
- No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis
- No prior allogeneic tissue/solid organ transplant
- Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
- No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
- No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
- Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
- No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible
- No hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
- No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
- No known hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 8 gm/dl
- Calculated (Calc.) creatinine clearance >= 45 mL/min
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
Who cannot join
None listed.
Trial locations and contacts
1,151 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
301 sites in 2 countries
United States300 sites, 163 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Jeffrey L. Berenberg
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Jeffrey L. Berenberg
- Suspended
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
- Suspended
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
- Suspended
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
- Suspended
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
- Recruiting
Hendrick Medical Center
Abilene, Texas, 79601
Site Public Contact, 325-670-6340
Jose C. Velasco Di Domenico
- Suspended
Hickman Cancer Center
Adrian, Michigan, 49221
- Suspended
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
- Recruiting
Cleveland Clinic Akron General
Akron, Ohio, 44307
Site Public Contact, 866-223-8100, CancerAnswer@ccf.org
Judy Peih-Ying Tsai
- Active, not recruiting
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Martha Mapalo
- Active, not recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
- Recruiting
University Cancer Specialists - Alcoa
Alcoa, Tennessee, 37701
Site Public Contact, 865-305-5120, bherbert@utmck.edu
Ardy Davarifar
- Suspended
Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, 71301
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Suspended
Aultman Alliance Community Hospital
Alliance, Ohio, 44601
- Suspended
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801
- Suspended
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707
- Suspended
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Liza C. Villaruz
- Active, not recruiting
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Eric C. McGary
- Suspended
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Suspended
Providence Alaska Medical Center
Anchorage, Alaska, 99508
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401
Site Public Contact, 443-481-1320, research@luminishealth.org
Barry R. Meisenberg
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Jennifer M. Suga
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Matthias Weiss
- Recruiting
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin, 54915
Site Public Contact, AWRI.inquiry@ascension.org
Jonathan S. Treisman
- Suspended
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
- Suspended
PCR Oncology
Arroyo Grande, California, 93420
- Suspended
Cone Health Cancer Center at Asheboro
Asheboro, North Carolina, 27203
- Suspended
Randolph Hospital
Asheboro, North Carolina, 27203
- Recruiting
Cone Health MedCenter Asheboro
Asheboro, North Carolina, 27205
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-303-3355, ClinicalTrials@northside.com
Ioana Bonta
- Recruiting
Sutter Auburn Faith Hospital
Auburn, California, 95602
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Suspended
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
- Suspended
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, 13021
- Suspended
MultiCare Auburn Medical Center
Auburn, Washington, 98001
- Recruiting
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Site Public Contact, 207-626-4855
Jessica J. Bian
- Recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas J. DiBella
- Suspended
The Medical Center of Aurora
Aurora, Colorado, 80012
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Tejas Patil
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Vamsi K. Vasireddy
- Active, not recruiting
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701
- Recruiting
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 305-674-2625, yenrique@msmc.com
Michael A. Schwartz
- Suspended
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
- Recruiting
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Eric C. McGary
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Active, not recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Site Public Contact, 443-849-3706
Mei Tang
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Site Public Contact, 410-601-9083
Vishal Jindal
- Recruiting
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237
Site Public Contact, 443-777-7364
Joshua E. Reuss
- Recruiting
Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland, 21244
Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org
James Liu
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Julie R. Brahmer
- Suspended
Eastern Maine Medical Center
Bangor, Maine, 04401
- Suspended
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Thomas J. Saphner
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Site Public Contact, 225-215-1353, clinicalresearch@marybird.com
Victor T. Lin
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Site Public Contact, 225-215-1353, clinicalresearch@marybird.com
Victor T. Lin
- Recruiting
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
Site Public Contact, 225-761-5346, Camille.Beck@Ochsner.org
Marc R. Matrana
- Active, not recruiting
Ochsner High Grove
Baton Rouge, Louisiana, 70836
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706
Site Public Contact, 516-734-8896
Kevin M. Sullivan
- Recruiting
Houston Methodist San Jacinto Hospital
Baytown, Texas, 77521
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Jun Zhang
- Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Liza C. Villaruz
- Suspended
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Recruiting
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Site Public Contact, 443-643-3010
Ashkan Bahrani
- Recruiting
MaineHealth Waldo Hospital
Belfast, Maine, 04915
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Jessica J. Bian
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Apar Kishor Ganti
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Eric C. McGary
- Suspended
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Suspended
Saint Charles Health System
Bend, Oregon, 97701
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, clinicalresearch@sutterhealth.org
Uma Suryadevara
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Beverly Hospital
Beverly, Massachusetts, 01915
Site Public Contact, 978-922-3000 ext. 2405
Paul J. Hesketh
- Suspended
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Suspended
Saint Vincent Healthcare
Billings, Montana, 59101
- Suspended
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Site Public Contact, 912-819-5704, underberga@sjchs.org
Mark A. Taylor
- Suspended
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Suspended
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Site Public Contact, 617-638-8265
Umit Tapan
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Site Public Contact, 617-667-9925
Daniel B. Costa
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Jacob M. Sands
- Suspended
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
- Recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas J. DiBella
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
- Suspended
Cox Cancer Center Branson
Branson, Missouri, 65616
- Suspended
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
- Recruiting
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Site Public Contact, 800-987-3005
Sarah J. Sinclair
- Recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Mohammed Almubarak
- Recruiting
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, 02135
Site Public Contact, 617-789-2903
Alys Malcolm
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Suspended
Bristol Regional Medical Center
Bristol, Tennessee, 37620
- Recruiting
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin, 53045
Site Public Contact, AWRI.Inquiry@Ascension.org
Jonathan S. Treisman
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Site Public Contact, 718-765-2500
Julie Huang
- Suspended
Crozer-Keystone Regional Cancer Center at Broomall
Broomall, Pennsylvania, 19008
- Suspended
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
- Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Site Public Contact, 484-476-2649, turzoe@mlhs.org
Deric C. Savior
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Edwin H. Yau
- Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
- Suspended
Saint Anne Hospital
Burien, Washington, 98166
- Suspended
Kaiser Permanente-Burke Medical Center
Burke, Virginia, 22015
- Suspended
Mills-Peninsula Medical Center
Burlingame, California, 94010
- Recruiting
Lahey Clinic
Burlington, Massachusetts, 01805
Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org
Paul J. Hesketh
- Recruiting
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com
Vinay K. Gudena
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Suspended
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Suspended
Cambridge Medical Center
Cambridge, Minnesota, 55008
- Active, not recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
- Suspended
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
- Recruiting
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, 13031
Site Public Contact, 315-472-7504
Steven M. Duffy
- Active, not recruiting
UPMC Camp Hill
Camp Hill, Pennsylvania, 17011
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Active, not recruiting
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Raza A. Khan
- Suspended
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Suspended
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
- Recruiting
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Liza C. Villaruz
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Suspended
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Active, not recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
- Suspended
Eden Hospital Medical Center
Castro Valley, California, 94546
- Recruiting
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Site Public Contact, 319-297-2900
Bharat Jenigiri
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Suspended
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
- Suspended
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
- Suspended
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
- Suspended
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
- Recruiting
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania, 17201
Site Public Contact, 717-217-6020
Dan Sotirescu
- Suspended
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
- Active, not recruiting
Roper Hospital
Charleston, South Carolina, 29401
- Active, not recruiting
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina, 29406
- Recruiting
Bon Secours Saint Francis Hospital
Charleston, South Carolina, 29414
Site Public Contact, 843-724-2466, Julia.Johnson@rsfh.com
George F. Geils
- Active, not recruiting
Lowcountry Oncology Associates - West Ashley
Charleston, South Carolina, 29414
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Mariam Alexander
- Active, not recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
- Active, not recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Site Public Contact, 314-205-6936
Meera Rana
- Suspended
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
- Active, not recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M. Tamkus
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Frank Weinberg
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Christine M. Bestvina
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Thomas J. Saphner
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin, 53014
Site Public Contact, AWRI.inquiry@ascension.org
Jonathan S. Treisman
- Active, not recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
- Suspended
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
- Suspended
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Suspended
Bethesda North Hospital
Cincinnati, Ohio, 45242
- Suspended
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
- Suspended
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramaswamy Govindan
- Suspended
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Recruiting
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
Site Public Contact, 888-716-9259
Jimmy Ruiz
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Site Public Contact, 216-778-7559, ababal@metrohealth.org
Peter Xie
- Recruiting
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Michael E. Menefee
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Michael E. Menefee
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Suspended
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Suspended
Billings Clinic-Cody
Cody, Wyoming, 82414
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Philip E. Lammers
- Suspended
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
- Suspended
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Tejas Patil
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Tejas Patil
- Recruiting
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Site Public Contact, 573-882-7440
RuoBing Xue
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Philip E. Lammers
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Active, not recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
- Active, not recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Active, not recruiting
Grant Medical Center
Columbus, Ohio, 43215
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Mount Carmel Health Center West
Columbus, Ohio, 43222
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Active, not recruiting
Doctors Hospital
Columbus, Ohio, 43228
- Active, not recruiting
John Muir Medical Center-Concord
Concord, California, 94520
- Recruiting
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Site Public Contact, 603-224-2556
Michael S. Buff
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Active, not recruiting
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
- Suspended
Bay Area Hospital
Coos Bay, Oregon, 97420
- Recruiting
Baptist Health Corbin
Corbin, Kentucky, 40701
Site Public Contact, 859-523-1934
Firas B. Badin
- Suspended
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
- Recruiting
Good Samaritan Hospital
Corvallis, Oregon, 97330
Site Public Contact, 541-768-4352, stmock@samhealth.org
John Strother
- Suspended
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Recruiting
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503
Site Public Contact, 712-322-4136
Robert M. Langdon
- Suspended
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
- Suspended
Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa, 51503
- Recruiting
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433
Site Public Contact, 225-215-1353, clinicalresearch@marybird.com
Victor T. Lin
- Recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
Site Public Contact, 985-809-5668, Cheryl.kesler@ochsner.org
Marc R. Matrana
- Suspended
Greater Regional Medical Center
Creston, Iowa, 50801
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramaswamy Govindan
- Recruiting
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
Site Public Contact, 219-836-6879, CancerResearch@powershealth.org
Vamsi K. Vasireddy
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Thomas J. Saphner
- Suspended
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
- Recruiting
UPMC Western Maryland
Cumberland, Maryland, 21502
Site Public Contact, 240-964-1400
Liza C. Villaruz
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
David E. Gerber
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
David E. Gerber
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
David E. Gerber
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Ahmad Hanif
- Active, not recruiting
MercyOne Genesis Davenport Medical Center
Davenport, Iowa, 52803
- Active, not recruiting
MercyOne Genesis Davenport Cancer Center
Davenport, Iowa, 52804
- Active, not recruiting
Iowa Cancer Specialists
Davenport, Iowa, 52807
- Suspended
Sutter Davis Hospital
Davis, California, 95616
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Site Public Contact, 248-551-7695
Joseph M. Anderson
- Suspended
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
- Active, not recruiting
Grady Memorial Hospital
Delaware, Ohio, 43015
- Suspended
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204
- Recruiting
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
National Jewish Health-Main Campus
Denver, Colorado, 80206
Site Public Contact, 877-225-5654, glicht@co-cancerresearch.org
Laurie L. Carr
- Suspended
The Women's Imaging Center
Denver, Colorado, 80209
- Suspended
AdventHealth Porter
Denver, Colorado, 80210
- Suspended
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Suspended
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
- Suspended
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
- Suspended
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
- Suspended
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
- Suspended
Rose Medical Center
Denver, Colorado, 80220
- Suspended
Western Surgical Care
Denver, Colorado, 80220
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Ashita Talsania
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Suspended
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Christopher M. Reynolds
- Suspended
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu
Ahmad Hanif
- Active, not recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
- Suspended
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Thomas J. Saphner
- Suspended
Doylestown Hospital
Doylestown, Pennsylvania, 18901
- Active, not recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Active, not recruiting
Epic Care-Dublin
Dublin, California, 94568
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Jennifer M. Suga
- Active, not recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
- Active, not recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
- Recruiting
Northside Hospital - Duluth
Duluth, Georgia, 30096
Site Public Contact, 404-303-3355, Clinical.trials@northside.com
Ioana Bonta
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
About this study
Official title: Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)
This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the disease free survival (DFS) between Arm B versus (vs) Arm C in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
SECONDARY OBJECTIVES:
- To compare the overall survival (OS) between the two treatment arms in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
II. To compare the adverse event rates and drug discontinuation rates due to adverse events in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
III. To compare the adverse event (AE) rates for Arms B and C with A (prior to Update #7) and estimate the DFS and OS in Arm A.
IV. To compare the DFS and OS in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer that receive at least 2 cycles of initial adjuvant chemotherapy.
QUALITY OF LIFE OBJECTIVES:
- To compare patient-reported quality of life (QOL) one year after randomization as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core (C)30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B), and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C).
II. To compare patient-reported QOL at completion of chemotherapy as assessed by the EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B) and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C).
III. To present longitudinal trajectories by arm of patient-reported dyspnea and coughing as assessed by the EORTC QLQ-Lung Cancer (LC13).
CORRELATIVE SCIENCE OBJECTIVES:
- To compare the DFS and OS in the PD-L1 subgroup of patients with PD-L1 expression status (>= 1% vs < 1%).
II. To compare the DFS and OS by tumor mutational burden status (high vs. low) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (CLOSED AS OF UPDATE #7 on 2/1/2022):
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then undergo observation.
ARM B:
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 17 cycles or every 6 weeks for 16 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.
ARM C:
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10/14/2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.
Patients also undergo echocardiogram (ECHO) as clinically indicated during screening and on the trial. Patients may undergo magnetic resonance imaging (MRI) during screening and as clinically indicated on the trial, as well as computed tomography (CT) and blood sample collection throughout the trial.
*ACCEPTABLE REGIMENS: DOUBLET I: Patients receive cisplatin IV and pemetrexed IV over 10 minutes on day 1 of each cycle.
DOUBLET II: Patients receive carboplatin IV over and pemetrexed IV over 10 minutes on day 1 of each cycle.
DOUBLET III: Patients receive cisplatin IV on day 1 of each cycle and gemcitabine hydrochloride IV on days 1 and 8 of each cycle.
DOUBLET IV: Patients receive carboplatin IV and paclitaxel IV over 1-96 hours on day 1 of each cycle.
After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for 2 years from randomization, every 6 months for years 2-4 from randomization, and then annually for up to 10 years from randomization.
- Conditions
- Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma, Lung Non-Squamous Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
- Being tested
- Biospecimen Collection, Carboplatin, Cisplatin, Computed Tomography, Echocardiography Test
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Observation ActivityOther
Also called Observation
Undergo observation
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
PembrolizumabBiological
Also called BCD-201, GME 751, GME751, Keytruda
Given IV
Pemetrexed DisodiumDrug
Also called Alimta, Almita, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
Given IV
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (platinum doublet, observation) | Active comparator | INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then undergo observation.
Patients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.
(CLOSED AS OF UPDATE #7) Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Other: Observation Activity; Drug: Paclitaxel; Drug: Pemetrexed Disodium; Other: Questionnaire Administration |
| Arm B (platinum doublet, sequential pembrolizumab) | Experimental | INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10/14/2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.
Patients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial. Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Biological: Pembrolizumab; Drug: Pemetrexed Disodium; Other: Questionnaire Administration |
| Arm C (platinum doublet, combination pembrolizumab) | Experimental | INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10/14/2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.
Patients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo a MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial. Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Biological: Pembrolizumab; Drug: Pemetrexed Disodium; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Will compare DFS between the two arms (combination versus sequential pembrolizumab added to standard of care platinum-based adjuvant therapy) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. Will be estimated using the Kaplan-Meier method, where the stratified log-rank test (using the central PD-L1 result for the PD-L1 expression status) will be used to compare the distributions across the treatment arms. DFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors (using the central PD-L1 result for the PD-L1 expression status) used in the randomization will be assessed as well.
Measured: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion
Secondary outcomes (4)
Overall survival (OS)
Will be estimated using the Kaplan-Meier method, where the stratified log-rank test (using the central PD-L1 result for the PD-L1 expression status) will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors (using the central PD-L1 result for the PD-L1 expression status) used in the randomization will be assessed as well.
Measured: From randomization to death from any cause, assessed up to completion of 5 years follow-up
Incidence of adverse events
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5. will compare the adverse event rates and drug discontinuation rates due to adverse events. To evaluate the adverse events profiles associated with each treatment arm, the maximum grade for each type of adverse event will be recorded for each patient and frequency tables will be reviewed to determine the overall patterns. The number and severity of grade 3 + adverse events will be tabulated and summarized. Analysis of the overall adverse event rates, as well as specific events of interest will involve chi-square tests or Fisher's exact tests. In addition, we will also compute and compare the total adverse event burden for each arm
Measured: Up to 10 years
DFS between each of the arms
Will compare the DFS by PD-L1 expression status (tumor proportion score [TPS] ≥ 50% versus [vs] TPS < 50% using the central PD-L1 expression status) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. This will be assessed using the treatment arm by PD-L1 expression status (using the central PD-L1 expression status) interaction effect on DFS. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models. Similar analyses will be performed for the correlative endpoints using the cut off of 1% for the PD-L1 expression status (using the central PD-L1 expression status), and tumor mutational burden (high vs low).
Measured: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion
OS between each of the arms
will compare the OS by PD-L1 expression status (TPS ≥ 50% vs TPS < 50% using the central PD-L1 expression status) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. This will be assessed using the treatment arm by PD-L1 expression status (using the central PD-L1 expression status) interaction effect on OS. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models. Similar analyses will be performed for the correlative endpoints using the cut off of 1% for the PD-L1 expression status (using the central PD-L1 expression status), and tumor mutational burden (high vs low).
Measured: From randomization to death from any cause, assessed up to completion of 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start16 Jun 2020
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jacob M Sands, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267848
- Sponsor's protocol ID
- NCI-2020-00751
- Other IDs
- NCI-2020-00751, A081801, A081801, U10CA180821
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2020
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Publications
Osarogiagbon RU, Cetnar JP, Aljumaily R. Optimal Use of Targeted Therapy and Immunotherapy in Early-Stage, Resectable Non-Small Cell Lung Cancer. Am Soc Clin Oncol Educ Book. 2026 Jun;46(3):e518244. doi: 10.1200/EDBK-26-518244. Epub 2026 Jun 23.
PubMed 42335416Frumm SM, Florez N, Lee JM, Rotow JK, Chaft JE. Updates on the Perioperative Management of Resectable Non-Small Cell Lung Cancer. J Natl Compr Canc Netw. 2026 Mar 24;24(4):e267005. doi: 10.6004/jnccn.2026.7005.
PubMed 41911908Booth A, Hillman S, Laumann K, Zhao YQ, LeBlanc M, Chansky K, Giri S, Dill J, Johnson J, Kelley K, Martin L, Osarogiagbon RU, Morris MJ, Chiang AC, Kozono DE, Blanke CD, Galanis E, Gray JE, Stinchcombe TE, Aljumaily R, Morgensztern D, Mandrekar SJ. PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials. J Thorac Oncol. 2026 Jul;21(7):103650. doi: 10.1016/j.jtho.2026.103650. Epub 2026 Feb 24.
PubMed 41747891Sands JM, Mandrekar SJ, Kozono D, Oxnard GR, Hillman SL, Wigle DA, Govindan R, Carlisle J, Gray J, Salama JK, Raez L, Ganti A, Foster N, Malik S, Bradley J, Kelly K, Ramalingam SS, Stinchcombe TE. Integration of immunotherapy into adjuvant therapy for resected non-small-cell lung cancer: ALCHEMIST chemo-IO (ACCIO). Immunotherapy. 2021 Jun;13(9):727-734. doi: 10.2217/imt-2021-0019. Epub 2021 Apr 21.
PubMed 33878954