Non-small Cell Lung CancerPhase 3NCT06422143
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
A Phase 3 study testing Pembrolizumab, sac-TMT and Carboplatin in people with Non-small Cell Lung Cancer and NSCLC, run by Merck Sharp & Dohme LLC at 217 sites in 26 countries.
Trial summary
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, NSCLC
- What is being tested?
- Pembrolizumab, sac-TMT and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 851 participants
- Where
- 217 sitesin 26 countries
- Study dates
- 10 Jun 2024to 15 Aug 2031
- 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
- Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) [Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8]
- Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
- Has life expectancy ≥3 months
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
- Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
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- Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)
- Has adequate organ function
- For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization
- For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
- For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered
- For Maintenance only (prior to randomization): has not experienced a pneumonitis/interstitial lung disease (ILD) event during the study-specified induction
Who cannot join
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
- HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
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- Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
- Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications
- Received prior treatment with a topoisomerase I inhibitor-containing ADC
- Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known central nervous system (CNS) metastases/carcinomatous meningitis
- Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
- Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy [eg, thyroxine, insulin, or physiologic corticosteroid] is allowed)
- Has a history of (noninfectious)pneumonitis/ILD that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
- Active infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
Trial locations and contacts
217 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
217 sites in 26 countries
Japan29 sites, 29 recruiting
- Recruiting
Chiba University Hospital ( Site 2517)
Chiba, 260-8677
Study Coordinator, +81-43-222-7171
- Recruiting
National Hospital Organization Kyushu Medical Center ( Site 2509)
Fukuoka, 810-8563
Study Coordinator, +81-92-852-0700
- Recruiting
Kansai Medical University Hospital ( Site 2503)
Hirakata, Osaka, 573-1191
Study Coordinator, +81-72-804-0101
- Recruiting
Hirosaki University Hospital ( Site 2514)
Hirosaki, Aomori, 036-8563
Study Coordinator, +81-172-33-5111
- Recruiting
Kanazawa University Hospital ( Site 2513)
Kanazawa, Ishikawa-ken, 920-8641
Study Coordinator, +81-76-265-2000
- Recruiting
National Cancer Center Hospital East ( Site 2501)
Kashiwa, Chiba, 277-8577
Study Coordinator, +81-47-133-1111
- Recruiting
St. Marianna University Hospital ( Site 2521)
Kawasaki, Kanagawa, 216-8511
Study Coordinator, +81-44-977-8111
- Recruiting
Saitama Prefectural Cancer Center ( Site 2512)
Kitaadachi-gun, Saitama, 362-0806
Study Coordinator, +81-48-722-1111
- Recruiting
Kobe Minimally Invasive Cancer Center ( Site 2528)
Kobe, Hyōgo, 650-0046
Study Coordinator, +81-78-304-4100
- Recruiting
Cancer Institute Hospital of JFCR ( Site 2500)
Koto, Tokyo, 135-8550
Study Coordinator, +81-3-3520-0111
- Recruiting
Saiseikai Matsusaka Municipal Hospital ( Site 2522)
Matsusaka, Mie-ken, 515-8544
Study Coordinator, +81-598-23-1515
- Recruiting
Aichi Cancer Center ( Site 2502)
Nagoya, Aichi-ken, 464-8681
Study Coordinator, +81-52-762-6111
- Recruiting
Nagoya University Hospital ( Site 2519)
Nagoya, Aichi-ken, 466-8560
Study Coordinator, +81-52-744-1958
- Recruiting
Kochi Medical School Hospital ( Site 2526)
Nankoku, Kochi, 783-8505
Study Coordinator, +81-88-866-5811
- Recruiting
Niigata Cancer Center Hospital ( Site 2505)
Niigata, 951-8566
Study Coordinator, +81-25-266-5111
- Recruiting
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2506)
Osaka, 541-8567
Study Coordinator, +81-6-6945-1181
- Recruiting
Gunma Prefectural Cancer Center ( Site 2510)
Ōta, Gunma, 373-8550
Study Coordinator, +81-27-638-0771
- Recruiting
Toho University Omori Medical Center ( Site 2520)
Ōta-ku, Tokyo, 143-8541
Study Coordinator, +81-3-3762-4151
- Recruiting
Tohoku University Hospital ( Site 2525)
Sendai, Miyagi, 980-8574
Study Coordinator, +81-22-717-7000
- Recruiting
Sendai Kousei Hospital ( Site 2507)
Sendai, Miyagi, 981-0914
Study Coordinator, +81-22-728-8000
- Recruiting
Dokkyo Medical University Hospital ( Site 2527)
Shimotsuga-gun, Tochigi, 321-0293
Study Coordinator, +81-282-86-1111
- Recruiting
National Center for Global Health and Medicine ( Site 2516)
Shinjuku, Tokyo, 162-8655
Study Coordinator, +81-3-3202-7181
- Recruiting
Takarazuka City Hospital ( Site 2508)
Takarazuka, Hyōgo, 665-0827
Study Coordinator, +81-797-87-1161
- Recruiting
Ehime University Hospital ( Site 2511)
Tōon, Ehime, 791-0295
Study Coordinator, +81-89-964-5111
- Recruiting
Fujita Health University Hospital ( Site 2515)
Toyoake, Aichi-ken, 470-1192
Study Coordinator, +81-562-93-2111
- Recruiting
National Hospital Organization Yamaguchi Ube Medical Center ( Site 2523)
Ube, Yamaguchi, 755-0241
Study Coordinator, +81-836-58-2300
- Recruiting
National Hospital Organization Ureshino Medical Center ( Site 2524)
Ureshino, Saga-ken, 843-0393
Study Coordinator, +81-954-43-1120
- Recruiting
Kanagawa Cardiovascular and Respiratory Center ( Site 2518)
Yokohama, Kanagawa, 236-0051
Study Coordinator, +81-45-701-9581
- Recruiting
Kanagawa Cancer Center ( Site 2504)
Yokohama, Kanagawa, 241-8515
Study Coordinator, +81-45-520-2222
China28 sites
- Active, not recruiting
Beijing Cancer Hospital ( Site 2411)
Beijing, Beijing Municipality, 100142
- Active, not recruiting
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410)
Beijing, Beijing Municipality, 100142
- Active, not recruiting
Peking Union Medical College Hospital ( Site 2412)
Beijing, Beijing Municipality, 100730
- Active, not recruiting
Jilin Province Tumor Hospital-GCP office ( Site 2413)
Changchun, Jilin, 130000
- Active, not recruiting
The First Hospital of Jilin University-Oncology ( Site 2414)
Changchun, Jilin, 130021
- Active, not recruiting
The Second Xiangya Hospital of Central South University-Oncology ( Site 2418)
Changsha, Hunan, 410011
- Active, not recruiting
West China Hospital, Sichuan University ( Site 2422)
Chengdu, Sichuan, 610041
- Active, not recruiting
Sichuan Cancer hospital. ( Site 2421)
Chengdu, Sichuan, 610042
- Active, not recruiting
Army Medical Center of People's Liberation Army-respiratory ( Site 2426)
Chongqing, Chongqing Municipality, 400042
- Active, not recruiting
Fujian Provincial Cancer Hospital ( Site 2419)
Fuzhou, Fujian, 350014
- Active, not recruiting
The First Affiliated Hospital of Guangzhou Medical University ( Site 2417)
Guangzhou, Guangdong, 510160
- Active, not recruiting
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2416)
Guangzhou, Guangdong, 510515
- Active, not recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine-Respiratory Department ( Site 2406)
Hangzhou, Zhejiang, 310000
- Active, not recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 2407)
Hangzhou, Zhejiang, 310016
- Active, not recruiting
Zhejiang Cancer Hospital-Breast Oncology ( Site 2408)
Hangzhou, Zhejiang, 310022
- Active, not recruiting
Harbin Medical University Cancer Hospital-oncology of department ( Site 2415)
Harbin, Heilongjiang, 150000
- Active, not recruiting
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 2402)
Huai'an, Jiangsu, 223300
- Active, not recruiting
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2405)
Nanchang, Jiangxi, 330006
- Active, not recruiting
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 2404)
Nanchang, Jiangxi, 330209
- Active, not recruiting
Shanghai East Hospital ( Site 2428)
Shanghai, Shanghai Municipality, 200120
- Active, not recruiting
Shanghai Pulmonary Hospital ( Site 2427)
Shanghai, Shanghai Municipality, 200433
- Active, not recruiting
Taizhou Hospital of Zhejiang Province ( Site 2430)
Taizhou, Zhejiang, 317000
- Active, not recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 2425)
Ürümqi, Xinjiang, 830000
- Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2409)
Wenzhou, Zhejiang, 325015
- Active, not recruiting
Tongji Hospital Tongji Medical,Science & Technology ( Site 2424)
Wuhan, Hubei, 430000
- Active, not recruiting
The First Affiliated hospital of Xiamen University-oncology ( Site 2420)
Xiamen, Fujian, 361003
- Active, not recruiting
Northern Jiangsu People's Hospital-General Surgery Department ( Site 2403)
Yangzhou, Jiangsu, 225001
- Active, not recruiting
Henan Cancer Hospital-Pneumology department ( Site 2423)
Zhengzhou, Henan, 450008
United States22 sites, 16 recruiting
- Completed
New Mexico Oncology Hematology Consultants Ltd. ( Site 0123)
Albuquerque, New Mexico, 87109
- Recruiting
University of New Mexico Comprehensive Cancer Center ( Site 0135)
Albuquerque, New Mexico, 87131
Study Coordinator, 505-272-4946
- Recruiting
St Luke's University Health Network ( Site 0017)
Bethlehem, Pennsylvania, 18015
Study Coordinator, 484-658-1792
- Recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122)
Burbank, California, 91505
Study Coordinator, 818-748-4723
- Recruiting
University of Chicago Medical Center ( Site 0145)
Chicago, Illinois, 60637
Study Coordinator, 773-352-1745
- Completed
Centricity Research Columbus Cancer Center ( Site 0111)
Columbus, Georgia, 31904
- Recruiting
Intermountain Health Cancer Center Lutheran Hospital ( Site 0119)
Golden, Colorado, 80401
Study Coordinator, 303-403-6381
- Recruiting
Intermountain Health St. Mary's Regional Hospital ( Site 0116)
Grand Junction, Colorado, 81501
Study Coordinator, 970-298-6576
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0035)
Hackensack, New Jersey, 07601
Study Coordinator, 551-996-5900
- Recruiting
Memorial Hermann Cancer Center ( Site 0015)
Houston, Texas, 77030
Study Coordinator, 281-540-7905
- Recruiting
Oncology Consultants P.A. ( Site 0124)
Houston, Texas, 77030
Study Coordinator, 713-600-0913
- Recruiting
CARTI Cancer Center ( Site 0006)
Little Rock, Arkansas, 72205
Study Coordinator, 501-906-3000
- Completed
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001)
Marietta, Georgia, 30060
- Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)
Minneapolis, Minnesota, 55407
Study Coordinator, 888-425-5462
- Completed
Southeastern Regional Medical Center ( Site 0004)
Newnan, Georgia, 30265
- Completed
Mid Florida Hematology and Oncology Center ( Site 0109)
Orange City, Florida, 32763
- Recruiting
Capital Health Medical Center - Hopewell ( Site 0034)
Pennington, New Jersey, 08534
Study Coordinator, 609-303-4733
- Recruiting
Thomas Jefferson University - Clinical Research Institute ( Site 0147)
Philadelphia, Pennsylvania, 19107
Study Coordinator, 215-955-8874
- Completed
Mays Cancer Center ( Site 0132)
San Antonio, Texas, 78229
- Recruiting
Sharp Memorial Hospital ( Site 9544)
San Diego, California, 92123
Study Coordinator, 858-939-7201
- Recruiting
Washington Hospital Center ( Site 0037)
Washington D.C., District of Columbia, 20010
Study Coordinator, 202-877-8839
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9552)
Ypsilanti, Michigan, 48197
Study Coordinator, 734-712-4950
Italy12 sites, 11 recruiting
- Recruiting
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414)
Brescia, 25123
Study Coordinator, 0303996536
- Recruiting
Ospedale San Martino ( Site 1407)
Genova, 16132
Study Coordinator, +390105558905
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1404)
Milan, Lombardy, 20133
Study Coordinator, 390223902190
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 1412)
Monza, Lombardy, 20900
Study Coordinator, 0392334514
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1401)
Naples, Campania, 80131
Study Coordinator, +390817770291
- Recruiting
Azienda Ospedaliera Maggiore della Carita ( Site 1416)
Novara, 28100
Study Coordinator, +3903213733989
- Recruiting
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 1410)
Pavia, 27100
Study Coordinator, 0382503938
- Recruiting
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409)
Rome, Lazio, 00184
Study Coordinator, +390677054001
- Recruiting
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1402)
Rome, Roma, 00144
Study Coordinator, +390652665075
- Recruiting
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1408)
Rozzano, Milano, 20089
Study Coordinator, +390282244069
- Completed
Ospedale di Circolo e Fondazione Macchi Varese-Oncology ( Site 1413)
Varese, 21100
- Recruiting
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi ( Site 1415)
Verona, 37134
Study Coordinator, +390458128120
Poland11 sites, 9 recruiting
- Recruiting
Bialostockie Centrum Onkologii ( Site 1520)
Bialystok, Podlaskie Voivodeship, 15-027
Study Coordinator, +48856646888
- Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1503)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Study Coordinator, 52 374 35 89
- Completed
Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1507)
Gorlice, Lesser Poland Voivodeship, 38-300
- Completed
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1513)
Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300
- Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1515)
Krakow, Lesser Poland Voivodeship, 31-826
Study Coordinator, +48126468634
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie ( Site 1518)
Lublin, Lublin Voivodeship, 20-090
Study Coordinator, +48814485180
- Recruiting
Szpital Wojewódzki w Koszalinie. ( Site 1517)
Poland, West Pomeranian Voivodeship, 75-581
Study Coordinator, 94 34 88 930
- Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 1510)
Poznań, Lower Silesian Voivodeship, 60-569
Study Coordinator, +48616654203
- Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1501)
Przemyśl, Podkarpackie Voivodeship, 37-700
Study Coordinator, 48 16 677 55 10
- Recruiting
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 1523)
Warsaw, Masovian Voivodeship, 01-138
Study Coordinator, +48224312100
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1500)
Warsaw, Masovian Voivodeship, 02-781
Study Coordinator, +48225463066
Brazil8 sites, 8 recruiting
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311)
Porto Alegre, Rio Grande do Sul, 90020-090
Study Coordinator, +555132148143
- Recruiting
Hospital Nossa Senhora da Conceição ( Site 0300)
Porto Alegre, Rio Grande do Sul, 91350-200
Study Coordinator, 555133572092
- Recruiting
Hospital do Cancer de Pernambuco ( Site 0312)
Recife, Pernambuco, 50040-000
Study Coordinator, : +55 81 99631 6566
- Recruiting
Instituto de Oncologia Saint Gallen ( Site 0304)
Santa Cruz do Sul, Rio Grande do Sul, 96830-180
Study Coordinator, 5551991898942
- Recruiting
Hospital de Base de São José do Rio Preto ( Site 0310)
São José do Rio Preto, São Paulo, 15090-000
Study Coordinator, (17) 3201-5054
- Recruiting
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 0302)
São Paulo, 01246-000
Study Coordinator, + 55 11 3893-2649
- Recruiting
Hospital Paulistano ( Site 0307)
São Paulo, 01321-001
Study Coordinator, +551131411083
- Recruiting
Vencer Centro de Pesquisa Clínica ( Site 0309)
Teresina, Piauí, 64049-200
Study Coordinator, +55 86 99900-7799
Romania8 sites, 8 recruiting
- Recruiting
SC ONCO CARD SRL ( Site 2007)
Brasov, 500052
Study Coordinator, +40268960
- Recruiting
Centrul Medical Medicover Victoria ( Site 2000)
Bucharest, Bucharest, 010626
Study Coordinator, +40219896
- Recruiting
Lotus-Med ( Site 2009)
Bucharest, 012292
Study Coordinator, +4021.9989
- Recruiting
Cardiomed SRL Cluj-Napoca ( Site 2002)
Cluj-Napoca, Cluj, 400015
Study Coordinator, +40264406600
- Recruiting
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2004)
Craiova, Dolj, 200542
Study Coordinator, +40731604432
- Recruiting
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2001)
Florești, Cluj, 407280
Study Coordinator, +40219368
- Recruiting
Clinica Polisano ( Site 2008)
Sibiu, 550253
Study Coordinator, +40219383
- Recruiting
Cabinet Medical Oncomed ( Site 2005)
Timișoara, Timiș County, 300239
Study Coordinator, +40356460995
South Korea8 sites, 8 recruiting
- Recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 2106)
Bupyeong-gu, Incheon, 21431
Study Coordinator, +82-32-280-5172
- Recruiting
Pusan National University Hospital ( Site 2100)
Busan, Pusan-Kwangyokshi, 49241
Study Coordinator, +82-51-240-7889
- Recruiting
Chungnam national university hospital-Department of Internal Medicine ( Site 2107)
Daejeon, Taejon-Kwangyokshi, 35015
Study Coordinator, +82422807140
- Recruiting
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2102)
Deagu, Taegu-Kwangyokshi, 41404
Study Coordinator, +532003091
- Recruiting
Kyung Hee University Hospital ( Site 2101)
Seoul, 02447
Study Coordinator, +82-2-958-8511
- Recruiting
Asan Medical Center ( Site 2105)
Seoul, 05505
Study Coordinator, +82-2-3010-5902
- Recruiting
Korea University Guro Hospital-Internal Medicine ( Site 2103)
Seoul, 08308
Study Coordinator, +82226261114
- Recruiting
Pusan National University Yangsan Hospital ( Site 2104)
Yangsan, Kyongsangnam-do, 50612
Study Coordinator, +82-55-360-4764
Taiwan8 sites, 8 recruiting
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung ( Site 2207)
Kaohsiung City, 83301
Study Coordinator, +88677317123
- Recruiting
Taichung Veterans General Hospital ( Site 2204)
Taichung, 407
Study Coordinator, +886423592525x3219
- Recruiting
National Cheng Kung University Hospital ( Site 2205)
Tainan, 704
Study Coordinator, +88662353535
- Recruiting
National Taiwan University Hospital-Oncology ( Site 2208)
Taipei, 10002
Study Coordinator, +886223123456x267511
- Recruiting
Mackay Memorial Hospital-Chest Medicine ( Site 2201)
Taipei, 10449
Study Coordinator, +88625433535
- Recruiting
National Taiwan University Cancer Center (NTUCC) ( Site 2209)
Taipei City, Taipei, 106
Study Coordinator, +886223123456x267511
- Recruiting
Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 2202)
Taoyuan, 333
Study Coordinator, +88633281200
- Recruiting
Taoyuan General Hospital ( Site 2203)
Taoyuan City, Taoyuan, 33004
Study Coordinator, +88633698721
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1801)
Ankara, 06230
Study Coordinator, +90 (312) 305 50 00
- Recruiting
Gazi Universitesi-Oncology ( Site 1804)
Ankara, 06560
Study Coordinator, +90 312 202 20 00
- Recruiting
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800)
Ankara, 06800
Study Coordinator, +90312 552 60 00
- Recruiting
Izmir Atatürk Training and Research Hospital ( Site 1810)
Izmir, 35360
Study Coordinator, +905324078648
- Recruiting
Memorial Kayseri Hastanesi ( Site 1805)
Kayseri, 38010
Study Coordinator, +90352315 66 66-6615
- Recruiting
Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1808)
Mersin, 33240
Study Coordinator, (0324) 225 10 00
- Recruiting
Samsun Medical Park Hastanesi-medical oncology ( Site 1806)
Samsun, 55200
Study Coordinator, +905334296797
- Recruiting
Medipol Mega Universite Hastanesi-oncology ( Site 1811)
Stanbul, Istanbul, 34214
Study Coordinator, +905325280486
Thailand7 sites, 7 recruiting
- Recruiting
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2300)
Bangkok, Bangkok, 10300
Study Coordinator, +6622443000
- Recruiting
Faculty of Medicine Siriraj Hospital ( Site 2301)
Bangkoknoi, Bangkok, 10700
Study Coordinator, +6624194489
- Recruiting
Songklanagarind hospital ( Site 2303)
Hat Yai, Changwat Songkhla, 90110
Study Coordinator, +6674451469
- Recruiting
Lampang Cancer Hospital ( Site 2304)
Lampang, Changwat Lampang, 52000
Study Coordinator, +6654335262
- Recruiting
Faculty of Medicine - Khon Kaen University ( Site 2305)
Muang, Changwat Khon Kaen, 40002
Study Coordinator, +6643366568
- Recruiting
Maharaj Nakorn Chiang Mai Hospital ( Site 2302)
Muang, Chiang Mai, 50200
Study Coordinator, +6653935480
- Recruiting
Prapokklao Hospital ( Site 2306)
Mueang, Changwat Chanthaburi, 22000
Study Coordinator, +6639319666
Argentina6 sites, 6 recruiting
- Recruiting
Fundacion Intecnus ( Site 0205)
Bariloche, Río Negro Province, R8402APU
Study Coordinator, 0294 474-6050
- Recruiting
Hospital Aleman-Oncology ( Site 0202)
Buenos Aires, C1118AAT
Study Coordinator, +54 11 4827-7000
- Recruiting
Instituto Alexander Fleming ( Site 0203)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Study Coordinator, 3221 8900 int 8123
- Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200)
Mar del Plata, Buenos Aires, B7600FZO
Study Coordinator, 0223 496-3224
- Recruiting
Instituto Médico Río Cuarto ( Site 0204)
Río Cuarto, Córdoba Province, X5800AEV
Study Coordinator, +543584679361
- Recruiting
Sanatorio Parque ( Site 0201)
Rosario, Santa Fe Province, S2000DSV
Study Coordinator, 0341 420-0222
Chile6 sites, 5 recruiting
- Recruiting
Bradford Hill Norte ( Site 0420)
Antofagasta, 1240000
Study Coordinator, 56442023631
- Recruiting
Fundación Arturo López Pérez ( Site 0409)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, +56224457254
- Recruiting
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0402)
Santiago, Region M. de Santiago, 8330024
Study Coordinator, +56223543334
- Recruiting
Bradfordhill-Clinical Area ( Site 0407)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, 56229490970
- Completed
Centro de Investigación del Maule ( Site 0419)
Talca, Maule Region, 3481349
- Recruiting
ONCOCENTRO APYS-ACEREY ( Site 0400)
Viña del Mar, Valparaiso, 2520598
Study Coordinator, 56323320850
France6 sites, 5 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest ( Site 0908)
Angers, Maine-et-Loire, 49055
Study Coordinator, 0244853754
- Recruiting
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902)
Avignon, Vaucluse, 84000
Study Coordinator, +33490276397
- Recruiting
CHD Vendee ( Site 0901)
La Roche-sur-Yon, Vendee, 85000
Study Coordinator, +33251446572
- Recruiting
Clinique Clairval ( Site 0904)
Marseille, Bouches-du-Rhone, 13009
Study Coordinator, +33496196230
- Completed
Hôpital Saint-Louis ( Site 0906)
Paris, 75475
- Recruiting
Hôpital Robert Schuman ( Site 0907)
Vantoux, Lorraine, 57070
Study Coordinator, +33387536012
Hungary6 sites, 6 recruiting
- Recruiting
Országos Korányi Pulmonológiai Intézet ( Site 1104)
Budapest, 1121
Study Coordinator, +3613913228
- Recruiting
Petz Aladar Egyetemi Oktato Korhaz ( Site 1101)
Győr, Győr-Moson-Sopron, 9024
Study Coordinator, +3696507900
- Recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)
Kecskemét, Bács-Kiskun county, 6000
Study Coordinator, +3676516700
- Recruiting
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1103)
Szolnok, Jász-Nagykun-Szolnok, 5004
Study Coordinator, +3656503603
- Recruiting
Reformatus Pulmonologiai Centrum ( Site 1102)
Törökbálint, Pest County, 2045
Study Coordinator, +36307005601
- Recruiting
Zala Megyei Szent Rafael Kórház ( Site 1110)
Zalaegerszeg, Zala County, 8900
Study Coordinator, +36 92 501527
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1700)
Barcelona, 08035
Study Coordinator, +34932746000
- Recruiting
Hospital Insular de Gran Canaria-Oncology ( Site 1701)
Las Palmas de Gran Canaria, Las Palmas, 35016
Study Coordinator, +34 928441738
- Recruiting
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 1702)
Madrid, 28040
Study Coordinator, 915504800 ext253900
- Recruiting
Hospital Quirón Málaga ( Site 1704)
Málaga, Malaga, 29004
Study Coordinator, +34 95 194 00 00
- Recruiting
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1703)
Santiago de Compostela, Galicia, 15706
Study Coordinator, +34981950511
- Recruiting
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1705)
Seville, 41014
Study Coordinator, 955015273
Canada5 sites, 5 recruiting
- Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100)
Kingston, Ontario, K7L 2V7
Study Coordinator, 613-549-6666
- Recruiting
Waterloo Regional Health Network (WRHN) ( Site 0153)
Kitchener, Ontario, N2G 1G3
Study Coordinator, 519749430
- Recruiting
St. Marys Hospital Center ( Site 0105)
Montreal, Quebec, H3T 1M5
Study Coordinator, 514-345-3511
- Recruiting
McGill University Health Centre ( Site 0103)
Montreal, Quebec, H4A 3J1
Study Coordinator, 514 934-1934
- Recruiting
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0106)
Trois-Rivières, Quebec, G8Z 3R9
Study Coordinator, 819-697-3333
Colombia5 sites, 4 recruiting
- Recruiting
Centro Cancerológico del Caribe (CECAC) ( Site 0509)
Barranquilla, Atlántico, 080002
Study Coordinator, +573132121774
- Recruiting
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0500)
Bogotá, Bogota D.C., 110131
Study Coordinator, +573219198898
- Recruiting
Fundación Valle del Lili-Oncology CIC ( Site 0505)
Cali, Valle del Cauca Department, 760032
Study Coordinator, + 57 3126160090
- Recruiting
Oncologos del Occidente ( Site 0504)
Pereira, Risaralda Department, 660001
Study Coordinator, +57 3187715522
- Active, not recruiting
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
Valledupar, Cesar Department, 200001
Germany5 sites, 5 recruiting
- Recruiting
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1003)
Berlin, 13353
Study Coordinator, +4930450665005
- Recruiting
GEFOS Gesellschaft f. onkologische Studien ( Site 1005)
Dortmund, North Rhine-Westphalia, 44309
Study Coordinator, +492312061692
- Recruiting
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1001)
Essen, North Rhine-Westphalia, 45136
Study Coordinator, +4920117424003
- Recruiting
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1006)
Gera, Thuringia, 07548
Study Coordinator, +493658287758
- Recruiting
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1000)
Lübeck, Schleswig-Holstein, 23538
Study Coordinator, +49 451 500 45002
Austria4 sites, 4 recruiting
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720)
Linz, Upper Austria, 4020
Study Coordinator, +4373276760
- Recruiting
Klinik Hietzing ( Site 0740)
Vienna, 1130
Study Coordinator, +43 1 80110 2471
- Recruiting
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730)
Vienna, 1140
Study Coordinator, 004319106042002
- Recruiting
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710)
Vienna, 1210
Study Coordinator, 00431277005634
Czechia4 sites, 4 recruiting
- Recruiting
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0800)
Brno, Brno-mesto, 656 53
Study Coordinator, +420532233843
- Recruiting
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0802)
Olomouc, 779 00
Study Coordinator, +420588443666
- Recruiting
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 0803)
Ostrava-Vitkovice, Ostrava Mesto, 703 00
Study Coordinator, +420595633400
- Recruiting
Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 0804)
Pardubice, Pardubice Region, 532 03
Study Coordinator, +420466016436
Israel4 sites, 3 recruiting
- Completed
Rambam Health Care Campus-Oncology Division ( Site 1302)
Haifa, 3109601
- Recruiting
Shaare Zedek Medical Center ( Site 1300)
Jerusalem, 9103102
Study Coordinator, 972-2-6555768
- Recruiting
Rabin Medical Center ( Site 1303)
Petah Tikva, 4941492
Study Coordinator, 972-3-9378086
- Recruiting
Sheba Medical Center ( Site 1301)
Ramat Gan, 5265601
Study Coordinator, +972-3-5307032
Peru4 sites, 3 recruiting
- Active, not recruiting
Clínicas AUNA Sede Chiclayo ( Site 0604)
Chiclayo, Lambayeque, 14001
- Recruiting
Oncosalud-Clinical Research ( Site 0600)
Lima, 15036
Study Coordinator, +51957511783
- Recruiting
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 0602)
Lima, 15076
Study Coordinator, +51997468543
- Recruiting
Clínica San Antonio ( Site 0606)
Trujillo, La Libertad, 13008
Study Coordinator, +51943529090
United Kingdom4 sites, 4 recruiting
- Recruiting
St Bartholomew's Hospital ( Site 1901)
London, London, City of, EC1A7BE
Study Coordinator, 1-888-577-8839
- Recruiting
North West Cancer Centre ( Site 1908)
Londonderry, Derry and Strabane, BT47 6SB
Study Coordinator, 02871345171
- Recruiting
City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)
Nottingham, Nottinghamshire, NG5 1PB
Study Coordinator, 1-888-577-8839
- Recruiting
Torbay Hospital ( Site 1906)
Torquay, Devon, TQ2 7AA
Study Coordinator, 01803 656629
United Arab Emirates2 sites
- Completed
Cleveland Clinic Abu Dhabi ( Site 2650)
Abu Dhabi, Abu Dhabi Emirate, 112412
- Completed
Burjeel Medical City ( Site 2600)
Abu Dhabi, Abu Dhabi Emirate, 92510
Ireland1 site, 1 recruiting
- Recruiting
St. James's Hospital ( Site 1200)
Dublin, D08 A978
Study Coordinator, +35314103606
About this study
Official title: Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
Read the detailed description
All participants undergo an initial induction phase of four cycles, each cycle consisting of pembrolizumab every 3 weeks (q3w) + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance.
- Conditions
- Non-small Cell Lung Cancer, NSCLC
- Being tested
- Pembrolizumab, sac-TMT, Carboplatin, Paclitaxel, Nab-paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called KEYTRUDA®, MK-3475, SCH 900475
Intravenous (IV) infusion
sac-TMTBiological
Also called MK-2870, Sacituzumab tirumotecan
IV infusion
CarboplatinDrug
Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
PaclitaxelDrug
Participants receive 200 mg/m^2 or 175 mg/m^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
Nab-paclitaxelDrug
Participants receive 100 mg/m^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Arm A: Pembrolizumab + sac-TMT | Experimental | During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. Note: per investigator discretion, carboplatin AUC 5 mg/mL/min q3w or paclitaxel 175mg/m2 q3w may be administered.
During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks. Receives: Biological: Pembrolizumab; Biological: sac-TMT; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Maintenance Arm B: Pembrolizumab Monotherapy | Active comparator | During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles.
During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks. Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is the time from randomization to death due to any cause.
Measured: Up to ~50 months
Secondary outcomes (11)
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to ~79 months
Number of Participants With ≥1 Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to ~79 months
Number of Participants Discontinuing from Study Therapy Due to AE(s)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a 30-item scale to assess the overall quality of life in cancer patients. The global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Measured: Baseline and up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
Measured: Baseline and up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
Measured: Baseline and up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The chest pain score is based on participant responses to item 40 e (1 = "Not at All" to 4 = "Very Much").
Measured: Baseline and up to ~79 months
Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30)
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. TTD in global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Measured: Up to ~79 months
TTD in Dyspnea Score (EORTC QLQ-C30 Item 8)
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. TTD in dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
Measured: Up to ~79 months
TTD in Cough Score (EORTC QLQ-LC13 Item 31)
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
Measured: Up to ~79 months
TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in chest pain score is based on participant responses to item 40 ("Have you had pain in your chest?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse chest pain.
Measured: Up to ~79 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start10 Jun 2024
- Primary completion12 Jan 2029 (estimated)
- Study completion15 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Model description
- Participants are allocated to a single induction arm, then assigned randomly to one of 2 maintenance arms.
- Masking
- None (open label)
- Enrolment
- 851 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422143
- Sponsor's protocol ID
- 2870-023
- Other IDs
- 2023-510128-66-00, U1111-1301-2790, jRCT2021240015, MK-2870-023, 2023
- Status last verified
- Oct 2026
- First submitted
- 15 May 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf