AzTrials
AzTrials

Advanced Lung Non-Small Cell CarcinomaPhase 2/3NCT05096663

Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

A Phase 2/3 study testing Cobalamin, Dexamethasone and Docetaxel in people with Advanced Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by SWOG Cancer Research Network at 350 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Read more about this study

Who is it for?
Any age
What is being tested?
Cobalamin, Dexamethasone and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
350 sitesUnited States
Study dates
15 Mar 2022to 1 Dec 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants must have been assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol
  • Participants must have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to randomization. Non-measurable disease must be assessed within 42 days prior to randomization. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
  • Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
  • Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization
  • Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (=< 10 mg daily prednisone or equivalent) prior to sub-study randomization
  • Participants must have progressed (in the opinion of the treating investigator) following the most recent line of therapy for non-small cell lung cancer (NSCLC)
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  • Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s)
  • Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent, or stage III in certain circumstances outlined below) given alone or in combination with platinum-based chemotherapy. Participants must have experienced disease progression during or after this regimen
  • Continuing the same agent(s) after progression counts as a single line of therapy. However, a change or addition in agent(s) after progression (e.g. the addition of chemotherapy to anti-PD-1 monotherapy after progression) counts as a subsequent line of therapy and would exclude the participant
  • For participants who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy:
  • If they experienced disease progression less than (<) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this counts as the single line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
  • If they experienced disease progression more than or equal to (>=) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this is not considered a line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
  • Participants must have recovered (=< grade 1) from any side effects of prior therapy, except for alopecia
  • Participants must be able to safely receive at least one of the investigator's choice of standard of care regimens, per the current FDA-approved package insert
  • Note: Pemetrexed is not FDA-approved for squamous cell NSCLC and must not be used to treat participants with squamous cell NSCLC
  • Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (obtained within 28 days prior to sub-study randomization)
  • Platelet count >= 100 x 10^3/uL(obtained within 28 days prior to sub-study randomization)
  • Hemoglobin >= 9 g/dL (obtained within 28 days prior to sub-study randomization)
  • Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study randomization). For participants with liver metastases, bilirubin must be =< 5 x IULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study randomization). For participants with liver metastases, ALT and AST must be =< 5 x IULN
  • Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization
  • Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization
  • Participants must have history and physical exam must be obtained within 28 days prior to sub-study randomization
  • Participants with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to sub-study randomization
  • Participants must also be offered participation in banking and in the correlative studies for collection and future use of specimens
  • Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Who cannot join

  • Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to registration and must not be planning to receive the CNS-specific treatment through the first cycle of the protocol therapy
  • Participants must not have experienced the following:
  • Any grade 3 or worse immune-related adverse event (irAE). Exception: asymptomatic nonbullous/nonexfoliative rash
  • Any unresolved grade 2 irAE
  • Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
  • Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
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  • Participants must not have any history of organ transplant that requires use of immunosuppressives
  • Participants must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
  • Participants must not have any known allergy or reaction to any component of the investigational formulations. If there is a known allergy or reaction to standard of care formulations, participants must be able to safely receive at least one of the standard of care options
  • Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to sub-study randomization, or serious uncontrolled cardiac arrhythmia
  • Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to sub-study randomization
  • Participants must not have an active or uncontrolled infection in the opinion of the treating investigator
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Participants must not have any of following:
  • Cirrhosis at a level of Child-Pugh B (or worse)
  • Cirrhosis (any degree) and a history of hepatic encephalopathy
  • Or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
  • Participants must not have received anti-CTLA4 therapy (e.g. ipilimumab, tremelimumab), or other immune-modulatory therapy (e.g. anti-TIM-3, anti-LAG-3, anti-GITR, IL-2, IL-15)
  • Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
  • Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
  • Participants must not have received nitrosoureas or mitomycin-c within 42 days prior to sub-study randomization
  • Participants must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 7 days prior to sub-study randomization. Inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
  • Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
  • Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
  • Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participant must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
  • Participants must not have an active autoimmune disease that has required systemic treatment within two years prior to sub-study randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • Participants must not have any history of primary immunodeficiency
  • Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and 4 months after completion of study treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures during the study and 4 months after study completion

Trial locations and contacts

350 sites in 1 country.

300 sites in 1 country

United States300 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • Veterans Administration Medical Center - Birmingham

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Kaiser Permanente-Burke Medical Center

    Burke, Virginia, 22015

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

  • UPMC Camp Hill

    Camp Hill, Pennsylvania, 17011

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Doctors Hospital

    Columbus, Ohio, 43228

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China Township, Michigan, 48054

  • Cancer Institute at Saint Francis Hospital

    East Hills, New York, 11548

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

  • Beebe South Coastal Health Campus

    Frankford, Delaware, 19945

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Oncology Hematology Associates

    Greenville, Pennsylvania, 16125

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mercyhealth Hospital and Cancer Center - Janesville

    Janesville, Wisconsin, 53548

  • McFarland Clinic PC-Jefferson

    Jefferson, Iowa, 50129

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Ascension Borgess Cancer Center

    Kalamazoo, Michigan, 49009

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Kaiser Permanente - Kensington Medical Center

    Kensington, Maryland, 20895

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Kaiser Permanente - Largo Medical Center

    Largo, Maryland, 20774

  • Memorial Medical Center - Las Cruces

    Las Cruces, New Mexico, 88011

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • McFarland Clinic PC-Marshalltown

    Marshalltown, Iowa, 50158

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102

  • Cone Heath Cancer Center at Mebane

    Mebane, North Carolina, 27302

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Bayhealth Hospital Sussex Campus

    Milford, Delaware, 19963

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Memorial Medical Center

    Modesto, California, 95355

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • UPMC-Coraopolis/Heritage Valley Radiation Oncology

    Moon Township, Pennsylvania, 15108

  • Virtua Samson Cancer Center

    Moorestown, New Jersey, 08057

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • UPMC Hillman Cancer Center - Part of Frick Hospital

    Mount Pleasant, Pennsylvania, 15666

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Arnold Palmer Cancer Center Medical Oncology Norwin

    N. Huntingdon, Pennsylvania, 15642

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • UPMC Cancer Center-Natrona Heights

    Natrona Heights, Pennsylvania, 15065

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Ascension Providence Hospitals - Novi

    Novi, Michigan, 48374

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Olathe Health Cancer Center

    Olathe, Kansas, 66061

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

  • Owensboro Health Mitchell Memorial Cancer Center

    Owensboro, Kentucky, 42303

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Lahey Medical Center-Peabody

    Peabody, Massachusetts, 01960

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • UPMC-Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Pottstown Hospital

    Pottstown, Pennsylvania, 19464

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Duke Women's Cancer Care Raleigh

    Raleigh, North Carolina, 27607

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Annie Penn Memorial Hospital

    Reidsville, North Carolina, 27320

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • Presbyterian Rust Medical Center/Jorgensen Cancer Center

    Rio Rancho, New Mexico, 87124

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • University of Rochester

    Rochester, New York, 14642

  • Mercyhealth Javon Bea Hospital - Rockton

    Rockford, Illinois, 61103

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

    Sanford, Maine, 04073

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

  • Ascension Providence Hospitals - Southfield

    Southfield, Michigan, 48075

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Springfield Regional Cancer Center

    Springfield, Ohio, 45504

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

  • Bhadresh Nayak MD PC-Sterling Heights

    Sterling Heights, Michigan, 48312

  • Trinity's Tony Teramana Cancer Center

    Steubenville, Ohio, 43952

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

Other trials in United States

About this study

Official title: A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. 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. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare overall survival (OS) between participants randomized to nogapendekin alfa (N-803 [ALT-803]) + pembrolizumab versus standard of care therapy. (Primary Resistance Cohort) II. To compare overall survival (OS) between participants randomized to N-803 (ALT-803) + pembrolizumab versus standard of care therapy. (Acquired Resistance Cohort)

SECONDARY OBJECTIVES:

  1. To compare investigator assessed progression-free survival (IA-PFS) with confirmation of progression by immune response criteria between the treatment arms.

II. To compare investigator assessed progression-free survival (IA-PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the treatment arms.

III. To compare the response rates between the arms. IV. To evaluate duration of response (DoR) among responders. V. To evaluate the frequency and severity of toxicities within each treatment arm.

TRANSLATIONAL MEDICINE OBJECTIVE:

  1. To establish a blood repository to pursue future studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive standard of care consisting of docetaxel intravenously (IV) over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa subcutaneously (SC) on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Being tested
Cobalamin, Dexamethasone, Docetaxel, Folic Acid, Gemcitabine
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.

  • CobalaminDietary supplement

    Also called B12 Vitamin, Cobalamin (1+), VIT B12, Vitamin B-12

    Given intramuscularly

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given orally (PO)

  • DocetaxelDrug

    Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • Folic AcidDietary supplement

    Also called 2-[4-[(2-amino-4-oxo-1H-pteridin-6-yl)methylamino]benzoyl]aminopentanedioic acid, FA, Folacin, Pteroylmonoglutamic Acid

    Given PO

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given IV

  • Nogapendekin AlfaDrug

    Also called ALT 803, ALT-803, ALT803, Fusion Protein Consisting of IL-15N72D and IL-15RaSu/FC

    Given SC

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

  • PemetrexedDrug

    Also called MTA, Multitargeted Antifolate, Pemfexy

    Given IV

  • RamucirumabBiological

    Also called Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806

    Given IV

Study groups in NCT05096663
Study groupRoleWhat they receive
Arm A (standard of care)Active comparatorPatients receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Dietary Supplement: Cobalamin; Drug: Dexamethasone; Drug: Docetaxel; Dietary Supplement: Folic Acid; Drug: Gemcitabine; Drug: Pemetrexed; Biological: Ramucirumab
Arm B (pembrolizumab, nogapendekin alfa)ExperimentalPatients receive pembrolizumab IV over 30 minutes and nogapendekin alfa SC on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Nogapendekin Alfa; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Investigator-assessed progression-free survival (IA-PFS)

    Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level.

    Measured: From date of sub-study randomization to date of first documentation of potential immune-response confirmed progression, or death due to any cause, assessed up to 2 years

  2. Duration of response (DoR)

    Measured: From date of first documentation of response (complete response or partial response) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start15 Mar 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096663
Sponsor's protocol ID
S1800D
Other IDs
NCI-2021-09852, S1800D, S1800D, U10CA180888
Status last verified
May 2026
First submitted
14 Oct 2021
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cobalamin, Dexamethasone and Docetaxel in people with Advanced Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by SWOG Cancer Research Network at 350 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 350 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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