Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

NCT06074588 | Active Not Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: 2870-0042023-503539-16-00jRCT2031240108U1111-1287-4913
• Study Type: interventional
• Target: 556
• Locations: 25 countries
• Sites: 194

Brief Summary

The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Anaplastic lymphoma kinase (ALK); Antibody-drug conjugate (ADC); Epidermal growth factor receptor (EGFR); Trophoblast cell-surface antigen 2 (TROP2)

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations

  PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.

  Up to approximately 35 months

• Overall Survival (OS) of Participants with NSCLC with EGFR mutations

  OS is defined as the time from randomization to death due to any cause.

  Up to approximately 41 months

Secondary Outcomes (15)

• PFS of All Participants with NSCLC

  Up to approximately 35 months

• OS of All Participants with NSCLC

  Up to approximately 41 months

• Objective Response Rate (ORR) of Participants with NSCLC with EGFR Mutations

  Up to approximately 35 months

• ORR of All Participants with NSCLC

  Up to approximately 35 months

• Duration of Response (DOR) of All Participants with NSCLC

  Up to approximately 6 years

Study Arms (2)

Sacituzumab tirumotecan

EXPERIMENTAL

Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

Biological: Sacituzumab tirumotecan

Chemotherapy

ACTIVE COMPARATOR

Participants will receive 75 mg/m\^2 of docetaxel or 500 mg/m\^2 of pemetrexed by IV infusion on Days 1 and 22 of every 6-week cycle.

Drug: Docetaxel; Drug: Pemetrexed

Interventions

Docetaxel DRUG

75 mg/m\^2 of docetaxel by IV Infusion

Also known as: TAXOTERE®

Chemotherapy

Pemetrexed DRUG

500 mg/m\^2 of pemetrexed by IV infusion

Also known as: ALIMTA®

Chemotherapy

Sacituzumab tirumotecan BIOLOGICAL

4 mg/kg of MK-sacituzumab tirumotecan by IV infusion

Also known as: SKB264, MK-2870

Sacituzumab tirumotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
• Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
• Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
• Measurable disease per RECIST 1.1 as assessed by the local site investigator.
• Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
• Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
• Have an ECOG performance status of 0 or 1 within 3 days before randomization.
• Has predominantly squamous cell histology NSCLC.
• Has mixed tumor(s) with small cell elements.
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
• Has Grade ≥2 peripheral neuropathy.
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (194)

UCLA Hematology/Oncology - Santa Monica ( Site 0023)

Los Angeles, California, 90404, United States

Location

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)

Jacksonville, Florida, 32224, United States

Location

Mid Florida Hematology and Oncology Center ( Site 0005)

Orange City, Florida, 32763, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)

Marietta, Georgia, 30060, United States

Location

Karmanos Cancer Institute ( Site 0018)

Detroit, Michigan, 48201, United States

Location

Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)

Rochester, Minnesota, 55905, United States

Location

Hattiesburg Clinic Hematology/Oncology ( Site 0010)

Hattiesburg, Mississippi, 39401, United States

Location

University Of Nebraska Medical Center ( Site 0011)

Omaha, Nebraska, 68198, United States

Location

Englewood Hospital and Medical Center ( Site 0033)

Englewood, New Jersey, 07631, United States

Location

Atlantic Health System Morristown Medical Center ( Site 0031)

Morristown, New Jersey, 07960, United States

Location

Capital Health Medical Center - Hopewell ( Site 0006)

Pennington, New Jersey, 08534, United States

Location

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)

Cincinnati, Ohio, 45219, United States

Location

Tennessee Oncology (0036)

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson (0037)

Houston, Texas, 77030, United States

Location

VCU Health Adult Outpatient Pavillion ( Site 0026)

Richmond, Virginia, 23298, United States

Location

St. George Private Hospital ( Site 3004)

Kogarah, New South Wales, 2217, Australia

Location

Westmead Hospital ( Site 3000)

Westmead, New South Wales, 2145, Australia

Location

Monash Health-Oncology Research ( Site 3001)

Clayton, Victoria, 3168, Australia

Location

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003)

Melbourne, Victoria, 3021, Australia

Location

Hospital Santa Rita de Cassia (Site 0449)

Vitória, Espírito Santo, 29043-260, Brazil

Location

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444)

Barretos, São Paulo, 14784400, Brazil

Location

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica (Site 0448)

São Paulo, 01246-000, Brazil

Location

Hospital Paulistano-Americas Oncologia ( Site 0441)

São Paulo, 01321-001, Brazil

Location

A. C. Camargo Cancer Center-CAPEC ( Site 0442)

São Paulo, 01509-010, Brazil

Location

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446)

São Paulo, 04014-012, Brazil

Location

William Osler Health System ( Site 0205)

Brampton, Ontario, L6R 3J7, Canada

Location

Princess Margaret Cancer Centre ( Site 0204)

Toronto, Ontario, M5G 2M9, Canada

Location

Centro Investigacion Cancer James Lind ( Site 0513)

Temuco, Araucania, 4780000, Chile

Location

Clinica Universidad Catolica del Maule-Oncology ( Site 0501)

Talca, Maule Region, 3465584, Chile

Location

Centro de Estudios Clínicos SAGA (Site 0517)

Santiago, Region M. de Santiago, 7500653, Chile

Location

Orlandi Oncologia-Oncology ( Site 0504)

Santiago, Region M. de Santiago, 7500713, Chile

Location

FALP-UIDO (Site 0509)

Santiago, Region M. de Santiago, 7500921, Chile

Location

K2 Oncology (Site 0514)

Santiago, Region M. de Santiago, 7520426, Chile

Location

Clínica RedSalud Vitacura (Site 0511)

Santiago, Region M. de Santiago, 7650018, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 0502)

Santiago, Region M. de Santiago, 8330024, Chile

Location

Bradfordhill-Clinical Area (Site 0507)

Santiago, Region M. de Santiago, 8420383, Chile

Location

ONCOCENTRO APYS-ACEREY (Site 0500)

Viña del Mar, Valparaiso, 2520598, Chile

Location

Anhui Provincial Cancer Hospital ( Site 2830)

Hefei, Anhui, 230031, China

Location

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810)

Beijing, Beijing Municipality, 100142, China

Location

Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815)

Beijing, Beijing Municipality, 100730, China

Location

Chongqing University Cancer Hospital-Medical Oncology ( Site 2814)

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Cancer Hospital ( Site 2819)

Fuzhou, Fujian, 350014, China

Location

The First Affiliated hospital of Xiamen University ( Site 2820)

Xiamen, Fujian, 361003, China

Location

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818)

Guangzhou, Guangdong, 510515, China

Location

Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816)

Nanning, Guangxi, 530200, China

Location

Harbin Medical University Cancer Hospital-oncology of department ( Site 2807)

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital-henan cancer hospital ( Site 2813)

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital Tongji Medical,Science & Technology ( Site 2805)

Wuhan, Hubei, 430000, China

Location

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806)

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital ( Site 2809)

Wuhan, Hubei, 430079, China

Location

The Second Xiangya Hospital of Central South University ( Site 2827)

Changsha, Hunan, 410011, China

Location

Hunan Cancer Hospital-thoracic oncology II ( Site 2808)

Changsha, Hunan, 410013, China

Location

Nanjing Drum Tower Hospital ( Site 2812)

Nangjing, Jiangsu, 210008, China

Location

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821)

Nanchang, Jiangxi, 330006, China

Location

Jilin Province Tumor Hospital-clinical research ( Site 2803)

Changchun, Jilin, 130103, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817)

Xi'an, Shaanxi, 710061, China

Location

Jinan Central Hospital-oncology department ( Site 2802)

Jinan, Shandong, 250013, China

Location

LinYi Cancer Hospital ( Site 2804)

Linyi, Shandong, 276001, China

Location

Shanghai Chest Hospital-Oncology department ( Site 2800)

Shanghai, Shanghai Municipality, 200030, China

Location

Fudan University Shanghai Cancer Center-Oncology ( Site 2811)

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital, Sichuan University-Lung cancer center ( Site 2826)

Chengdu, Sichuan, 610041, China

Location

Sichuan Cancer hospital. ( Site 2822)

Chengdu, Sichuan, 610042, China

Location

Yunnan Province Cancer Hospital ( Site 2824)

Kunming, Yunnan, 650107, China

Location

Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828)

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital ( Site 2829)

Hangzhou, Zhejiang, 310022, China

Location

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100)

Brno, Brno-mesto, 656 53, Czechia

Location

Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 1103)

Ostrava, Ostrava Mesto, 703 00, Czechia

Location

Fakultni nemocnice Plzen ( Site 1104)

Pilsen, Plzeň Region, 305 99, Czechia

Location

Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)

Olomouc, 779 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105)

Prague, 122 00, Czechia

Location

Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303)

Bordeaux, Aquitaine, 33076, France

Location

CENTRE LEON BERARD ( Site 1305)

Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

Location

CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300)

Rouen, Haute-Normandie, 76031, France

Location

Groupe hospitalier Paris saint Joseph. ( Site 1307)

Paris, 75014, France

Location

Institut Curie-Thorax Institute ( Site 1304)

Paris, 75248, France

Location

Universitaetsklinikum Freiburg ( Site 1405)

Freiburg, Brandenburg, 79106, Germany

Location

Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407)

Göttingen, Lower Saxony, 37075, Germany

Location

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400)

Essen, North Rhine-Westphalia, 45136, Germany

Location

Klinikum Chemnitz - Flemmingstraße ( Site 1401)

Chemnitz, Saxony, 09116, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402)

Dresden, Saxony, 01307, Germany

Location

Asklepios Klinik Harburg ( Site 1403)

Hamburg, 21075, Germany

Location

Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705)

Athens, Attica, 115 26, Greece

Location

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700)

Athens, Attica, 115 27, Greece

Location

Aretaieio Hospital ( Site 2702)

Athens, Attica, 115 28, Greece

Location

ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704)

Chaidari, Athens, Attica, 124 62, Greece

Location

"Theagenio" Cancer Hospital of Thessaloniki ( Site 2703)

Thessaloniki, Central Macedonia, 540 07, Greece

Location

Papageorgiou General Hospital of Thessaloniki ( Site 2701)

Thessaloniki, 564 29, Greece

Location

Hong Kong Integrated Oncology Centre ( Site 3200)

Central, 0000, Hong Kong

Location

Queen Mary Hospital ( Site 3203)

Hksar, Hong Kong

Location

Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204)

Kowloon, 999077, Hong Kong

Location

Princess Margaret Hospital-Department of Oncology ( Site 3201)

Lai Chi Kok, Hong Kong

Location

Rambam Health Care Campus-Oncology Division ( Site 1702)

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center ( Site 1700)

Jerusalem, 9103102, Israel

Location

Rabin Medical Center ( Site 1703)

Petah Tikva, 4941492, Israel

Location

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1806)

Meldola, Emilia-Romagna, 47014, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)

Milan, Lombardy, 20133, Italy

Location

Istituto Clinico Humanitas ( Site 1803)

Rozzano, Lombardy, 20089, Italy

Location

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805)

Rome, Roma, 00144, Italy

Location

Aichi Cancer Center ( Site 3400)

Nagoya, Aichi-ken, 464-8681, Japan

Location

Fujita Health University Hospital ( Site 3419)

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East ( Site 3406)

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 3415)

Matsuyama, Ehime, 791-0280, Japan

Location

Gunma Prefectural Cancer Center ( Site 3418)

Otashi, Gunma, 373-8550, Japan

Location

Takarazuka City Hospital ( Site 3409)

Takarazuka, Hyōgo, 665-0827, Japan

Location

Kanazawa University Hospital ( Site 3414)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kanagawa Cancer Center ( Site 3404)

Yokohama, Kanagawa, 241-8515, Japan

Location

Miyagi Cancer Center ( Site 3416)

Natori-shi, Miyagi, 981-1293, Japan

Location

Sendai Kousei Hospital ( Site 3401)

Sendai, Miyagi, 981-0914, Japan

Location

Niigata Cancer Center Hospital ( Site 3405)

Niigata, Niigata, 951-8566, Japan

Location

Kansai Medical University Hospital ( Site 3410)

Hirakata, Osaka, 573-1191, Japan

Location

Shizuoka Cancer Center ( Site 3403)

Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan

Location

Cancer Institute Hospital of JFCR ( Site 3402)

Koto, Tokyo, 135-8550, Japan

Location

Chiba University Hospital ( Site 3411)

Chiba, 260-8677, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 3412)

Fukuoka, 810-8563, Japan

Location

Kyushu University Hospital ( Site 3407)

Fukuoka, 812-8582, Japan

Location

Okayama University Hospital ( Site 3417)

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute ( Site 3413)

Osaka, 541-8567, Japan

Location

Nippon Medical School Hospital ( Site 3408)

Tokyo, 113-8603, Japan

Location

Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502)

Kota Bharu, Kelantan, 15586, Malaysia

Location

National Cancer Institute-Radiotherapy and Oncology ( Site 3504)

Putrajaya, Kuala Lumpur, 62250, Malaysia

Location

Sarawak General Hospital-Radiotherapy Unit ( Site 3500)

Kuching, Sarawak, 93586, Malaysia

Location

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706)

Guadalajara, Jalisco, 44630, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704)

Monterrey, Nuevo León, 66460, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 0701)

Oaxaca City, Oaxaca, 68020, Mexico

Location

Clinica Integral Internacional de Oncología ( Site 0705)

Puebla City, 72530, Mexico

Location

THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600)

Iloilo City, Iloilo, 5000, Philippines

Location

Manila Doctors Hospital-Clinical Trial Office ( Site 3604)

Manila, National Capital Region, 1000, Philippines

Location

Asian Hospital and Medical Center ( Site 3605)

Muntinlupa, National Capital Region, 1780, Philippines

Location

THE MEDICAL CITY-Cancer Research Center ( Site 3603)

Pasig, National Capital Region, 1604, Philippines

Location

ST. LUKE'S MEDICAL CENTER ( Site 3601)

Quezon City, National Capital Region, 1102, Philippines

Location

CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602)

San Juan City, Metro Manila, National Capital Region, 1502, Philippines

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009)

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011)

Warsaw, Masovian Voivodeship, 01-138, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

Location

Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807)

Hwasun, Jeonranamdo, 58128, South Korea

Location

National Cancer Center-Lung Cancer Center ( Site 3810)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital ( Site 3806)

Seongnam, Kyonggi-do, 13620, South Korea

Location

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803)

Suwon, Kyonggi-do, 16247, South Korea

Location

Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811)

Yangsan, Kyongsangnam-do, 50612, South Korea

Location

Chungbuk National University Hospital-Internal medicine ( Site 3809)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Pusan National University Hospital ( Site 3805)

Busan, Pusan-Kwangyokshi, 49241, South Korea

Location

Chungnam national university hospital ( Site 3808)

Junggu, Taejon-Kwangyokshi, 35015, South Korea

Location

Kangbuk Samsung Hospital ( Site 3813)

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804)

Seoul, 03722, South Korea

Location

Konkuk University Medical Center ( Site 3812)

Seoul, 05030, South Korea

Location

Asan Medical Center ( Site 3801)

Seoul, 05505, South Korea

Location

Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)

Seoul, 06351, South Korea

Location

Korea University Guro Hospital-Internal Medicine ( Site 3800)

Seoul, 08308, South Korea

Location

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304)

Barcelona, Catalonia, 08036, Spain

Location

Hospital Insular de Gran Canaria-Oncology ( Site 2305)

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303)

Madrid, Madrid, Comunidad de, 28009, Spain

Location

H.R.U Málaga - Hospital General-Oncology ( Site 2302)

Málaga, Malaga, 29011, Spain

Location

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300)

Barcelona, 08035, Spain

Location

Clinica Universidad de Navarra-Medical Oncology ( Site 2306)

Madrid, 28027, Spain

Location

Chi Mei Medical Center ( Site 3910)

Tainan, Tainan, 71004, Taiwan

Location

National Taiwan University Cancer Center (NTUCC) ( Site 3903)

Taipei City, Taipei, 106, Taiwan

Location

Changhua Christian Hospital ( Site 3908)

Changhua, 50006, Taiwan

Location

National Taiwan University Hospital - Hsinchu branch ( Site 3907)

Hsinchu, 300, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912)

Kaohsiung City, 807, Taiwan

Location

E-Da hospital ( Site 3911)

Kaohsiung City, 82445, Taiwan

Location

Chang Gung Memorial Hospital at Kaohsiung ( Site 3906)

Kaohsiung City, 83301, Taiwan

Location

National Cheng Kung University Hospital ( Site 3909)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital-Oncology ( Site 3904)

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital-Chest Medicine ( Site 3902)

Taipei, 10449, Taiwan

Location

Taipei Medical University Hospital ( Site 3900)

Taipei, 110301, Taiwan

Location

Faculty of Medicine Siriraj Hospital ( Site 4000)

Bangkok, Bangkok, 10700, Thailand

Location

Lampang Cancer Hospital ( Site 4005)

Muang, Changwat Lampang, 52000, Thailand

Location

Songklanagarind hospital ( Site 4001)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 4003)

Muang, Chiang Mai, 50200, Thailand

Location

Faculty of Medicine - Khon Kaen University ( Site 4004)

Khon Kaen, 40002, Thailand

Location

Sunpasitthiprasong Hospital-Oncology ( Site 4002)

Ubon Ratchathani, 34000, Thailand

Location

Medipol Mega Universite Hastanesi-oncology ( Site 2505)

Stanbul, Istanbul, 34214, Turkey (Türkiye)

Location

Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Adana Medical Park Seyhan Hastanesi ( Site 2506)

Adana, 01140, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501)

Ankara, 06800, Turkey (Türkiye)

Location

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)

Istanbul, 34722, Turkey (Türkiye)

Location

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606)

London, Kensington and Chelsea, SW3 6JJ, United Kingdom

Location

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600)

London, London, City of, EC1A 7BE, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603)

London, London, City of, SE1 9RT, United Kingdom

Location

Royal Marsden Hospital (Sutton) ( Site 2605)

Sutton, Surrey, SM2 5PT, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 2604)

Manchester, m20 4bx, United Kingdom

Location

The Clatterbridge Cancer Centre ( Site 2602)

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Hanoi Oncology Hospital ( Site 4102)

Hanoi, Hanoi, 100000, Vietnam

Location

K Hospital - National Cancer Hospital ( Site 4105)

Hanoi, Hanoi, 100000, Vietnam

Location

National Lung Hospital-Oncology Department ( Site 4104)

Hanoi, Hanoi, 100000, Vietnam

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: November 12, 2023
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): March 11, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); AU (4); CN (28); MY (3); FR (5); JP (20); VN (3); US (15); GR (6); CL (10); HK (4); ME (4); ES (7); TU (6); DE (6); PL (7); CZ (5); CA (2); TW (11); BR (8); GB (6); TH (6); PH (6); IL (3); KR (14)