AzTrials
AzTrials

Non-small Cell Lung Cancer (NSCLC)Phase 3NCT06074588

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)

A Phase 3 study testing Sacituzumab tirumotecan, Docetaxel and Pemetrexed in people with Non-small Cell Lung Cancer (NSCLC), run by Merck Sharp & Dohme LLC at 195 sites in 25 countries.

Active, not recruiting

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

Official record
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Trial 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… 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?
Sacituzumab tirumotecan, Docetaxel and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
556 participants
Where
195 sitesin 25 countries
Study dates
12 Nov 2023to 11 Mar 2030
Phase
Phase 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
  • Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
  • Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
  • Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
  • Received prior treatment with a topoisomerase I-containing ADC.
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Active infection requiring systemic therapy.
  • History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
  • Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Trial locations and contacts

195 sites in 25 countries.

195 sites in 25 countries

China28 sites

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

    Beijing, Beijing Municipality, 100142

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

    Beijing, Beijing Municipality, 100730

  • Jilin Province Tumor Hospital-clinical research ( Site 2803)

    Changchun, Jilin, 130103

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

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital-thoracic oncology II ( Site 2808)

    Changsha, Hunan, 410013

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

    Chengdu, Sichuan, 610041

  • Sichuan Cancer hospital. ( Site 2822)

    Chengdu, Sichuan, 610042

  • Chongqing University Cancer Hospital-Medical Oncology ( Site 2814)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital ( Site 2819)

    Fuzhou, Fujian, 350014

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

    Guangzhou, Guangdong, 510515

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

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital ( Site 2829)

    Hangzhou, Zhejiang, 310022

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

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Cancer Hospital ( Site 2830)

    Hefei, Anhui, 230031

  • Jinan Central Hospital-oncology department ( Site 2802)

    Jinan, Shandong, 250013

  • Yunnan Province Cancer Hospital ( Site 2824)

    Kunming, Yunnan, 650107

  • LinYi Cancer Hospital ( Site 2804)

    Linyi, Shandong, 276001

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

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital ( Site 2812)

    Nangjing, Jiangsu, 210008

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

    Nanning, Guangxi, 530200

  • Shanghai Chest Hospital-Oncology department ( Site 2800)

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Shanghai Cancer Center-Oncology ( Site 2811)

    Shanghai, Shanghai Municipality, 200032

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

    Wuhan, Hubei, 430000

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

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital ( Site 2809)

    Wuhan, Hubei, 430079

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

    Xi'an, Shaanxi, 710061

  • The First Affiliated hospital of Xiamen University ( Site 2820)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital-henan cancer hospital ( Site 2813)

    Zhengzhou, Henan, 450000

Other trials in China

Japan20 sites

  • Chiba University Hospital ( Site 3411)

    Chiba, 260-8677

  • National Hospital Organization Kyushu Medical Center ( Site 3412)

    Fukuoka, 810-8563

  • Kyushu University Hospital ( Site 3407)

    Fukuoka, 812-8582

  • Kansai Medical University Hospital ( Site 3410)

    Hirakata, Osaka, 573-1191

  • Kanazawa University Hospital ( Site 3414)

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East ( Site 3406)

    Kashiwa, Chiba, 277-8577

  • Cancer Institute Hospital of JFCR ( Site 3402)

    Koto, Tokyo, 135-8550

  • National Hospital Organization Shikoku Cancer Center ( Site 3415)

    Matsuyama, Ehime, 791-0280

  • Shizuoka Cancer Center ( Site 3403)

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

  • Aichi Cancer Center ( Site 3400)

    Nagoya, Aichi-ken, 464-8681

  • Miyagi Cancer Center ( Site 3416)

    Natori-shi, Miyagi, 981-1293

  • Niigata Cancer Center Hospital ( Site 3405)

    Niigata, Niigata, 951-8566

  • Okayama University Hospital ( Site 3417)

    Okayama, 700-8558

  • Osaka International Cancer Institute ( Site 3413)

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center ( Site 3418)

    Otashi, Gunma, 373-8550

  • Sendai Kousei Hospital ( Site 3401)

    Sendai, Miyagi, 981-0914

  • Takarazuka City Hospital ( Site 3409)

    Takarazuka, Hyōgo, 665-0827

  • Nippon Medical School Hospital ( Site 3408)

    Tokyo, 113-8603

  • Fujita Health University Hospital ( Site 3419)

    Toyoake, Aichi-ken, 470-1192

  • Kanagawa Cancer Center ( Site 3404)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States16 sites

  • Tennessee Oncology Chattanooga (Site 0038)

    Chattanooga, Tennessee, 37404

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

    Cincinnati, Ohio, 45219

  • Karmanos Cancer Institute ( Site 0018)

    Detroit, Michigan, 48201

  • Englewood Hospital and Medical Center ( Site 0033)

    Englewood, New Jersey, 07631

  • Hattiesburg Clinic Hematology/Oncology ( Site 0010)

    Hattiesburg, Mississippi, 39401

  • University of Texas MD Anderson (0037)

    Houston, Texas, 77030

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

    Jacksonville, Florida, 32224

  • UCLA Hematology/Oncology - Santa Monica ( Site 0023)

    Los Angeles, California, 90404

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

    Marietta, Georgia, 30060

  • Atlantic Health System Morristown Medical Center ( Site 0031)

    Morristown, New Jersey, 07960

  • Tennessee Oncology (0036)

    Nashville, Tennessee, 37203

  • University Of Nebraska Medical Center ( Site 0011)

    Omaha, Nebraska, 68198

  • Mid Florida Hematology and Oncology Center ( Site 0005)

    Orange City, Florida, 32763

  • Capital Health Medical Center - Hopewell ( Site 0006)

    Pennington, New Jersey, 08534

  • VCU Health Adult Outpatient Pavillion ( Site 0026)

    Richmond, Virginia, 23298

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

    Rochester, Minnesota, 55905

Other trials in United States

South Korea14 sites

  • Pusan National University Hospital ( Site 3805)

    Busan, Pusan-Kwangyokshi, 49241

  • Chungbuk National University Hospital-Internal medicine ( Site 3809)

    Cheongju-si, North Chungcheong, 28644

  • National Cancer Center-Lung Cancer Center ( Site 3810)

    Goyang-si, Kyonggi-do, 10408

  • Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807)

    Hwasun, Jeonranamdo, 58128

  • Chungnam national university hospital ( Site 3808)

    Junggu, Taejon-Kwangyokshi, 35015

  • Seoul National University Bundang Hospital ( Site 3806)

    Seongnam, Kyonggi-do, 13620

  • Kangbuk Samsung Hospital ( Site 3813)

    Seoul, 03181

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

    Seoul, 03722

  • Konkuk University Medical Center ( Site 3812)

    Seoul, 05030

  • Asan Medical Center ( Site 3801)

    Seoul, 05505

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

    Seoul, 06351

  • Korea University Guro Hospital-Internal Medicine ( Site 3800)

    Seoul, 08308

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

    Suwon, Kyonggi-do, 16247

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

    Yangsan, Kyongsangnam-do, 50612

Other trials in South Korea

Taiwan11 sites

  • Changhua Christian Hospital ( Site 3908)

    Changhua, 50006

  • National Taiwan University Hospital - Hsinchu branch ( Site 3907)

    Hsinchu, 300

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

    Kaohsiung City, 807

  • E-Da hospital ( Site 3911)

    Kaohsiung City, 82445

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3906)

    Kaohsiung City, 83301

  • Chi Mei Medical Center ( Site 3910)

    Tainan, Tainan, 71004

  • National Cheng Kung University Hospital ( Site 3909)

    Tainan, 704

  • National Taiwan University Hospital-Oncology ( Site 3904)

    Taipei, 10002

  • Mackay Memorial Hospital-Chest Medicine ( Site 3902)

    Taipei, 10449

  • Taipei Medical University Hospital ( Site 3900)

    Taipei, 110301

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

    Taipei City, Taipei, 106

Other trials in Taiwan

Chile10 sites

  • Centro de Estudios Clínicos SAGA (Site 0517)

    Santiago, Region M. de Santiago, 7500653

  • Orlandi Oncologia-Oncology ( Site 0504)

    Santiago, Region M. de Santiago, 7500713

  • FALP-UIDO (Site 0509)

    Santiago, Region M. de Santiago, 7500921

  • K2 Oncology (Site 0514)

    Santiago, Region M. de Santiago, 7520426

  • Clínica RedSalud Vitacura (Site 0511)

    Santiago, Region M. de Santiago, 7650018

  • Pontificia Universidad Catolica de Chile ( Site 0502)

    Santiago, Region M. de Santiago, 8330024

  • Bradfordhill-Clinical Area (Site 0507)

    Santiago, Region M. de Santiago, 8420383

  • Clinica Universidad Catolica del Maule-Oncology ( Site 0501)

    Talca, Maule Region, 3465584

  • Centro Investigacion Cancer James Lind ( Site 0513)

    Temuco, Araucania, 4780000

  • ONCOCENTRO APYS-ACEREY (Site 0500)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Brazil8 sites

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

    Barretos, São Paulo, 14784400

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

    Natal, Rio Grande do Norte, 59075-740

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

    Porto Alegre, Rio Grande do Sul, 91350-200

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

    São Paulo, 01246-000

  • Hospital Paulistano-Americas Oncologia ( Site 0441)

    São Paulo, 01321-001

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

    São Paulo, 01509-010

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

    São Paulo, 04014-012

  • Hospital Santa Rita de Cassia (Site 0449)

    Vitória, Espírito Santo, 29043-260

Other trials in Brazil

Poland7 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

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

    Gliwice, Silesian Voivodeship, 44-102

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

    Kielce, Świętokrzyskie Voivodeship, 25-734

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

    Przemyśl, Podkarpackie Voivodeship, 37-700

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

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011)

    Warsaw, Masovian Voivodeship, 01-138

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Spain7 sites

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

    Barcelona, Catalonia, 08036

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

    Barcelona, 08035

  • Hospital Insular de Gran Canaria-Oncology ( Site 2305)

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303)

    Madrid, Madrid, Comunidad de, 28009

  • Clinica Universidad de Navarra-Medical Oncology ( Site 2306)

    Madrid, 28027

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

    Málaga, Malaga, 29011

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301)

    Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

Germany6 sites

  • Klinikum Chemnitz - Flemmingstraße ( Site 1401)

    Chemnitz, Saxony, 09116

  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402)

    Dresden, Saxony, 01307

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

    Essen, North Rhine-Westphalia, 45136

  • Universitaetsklinikum Freiburg ( Site 1405)

    Freiburg, Brandenburg, 79106

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

    Göttingen, Lower Saxony, 37075

  • Asklepios Klinik Harburg ( Site 1403)

    Hamburg, 21075

Other trials in Germany

Greece6 sites

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

    Athens, Attica, 115 26

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

    Athens, Attica, 115 27

  • Aretaieio Hospital ( Site 2702)

    Athens, Attica, 115 28

  • ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704)

    Chaidari, Athens, Attica, 124 62

  • "Theagenio" Cancer Hospital of Thessaloniki ( Site 2703)

    Thessaloniki, Central Macedonia, 540 07

  • Papageorgiou General Hospital of Thessaloniki ( Site 2701)

    Thessaloniki, 564 29

Other trials in Greece

Philippines6 sites

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

    Iloilo City, Iloilo, 5000

  • Manila Doctors Hospital-Clinical Trial Office ( Site 3604)

    Manila, National Capital Region, 1000

  • Asian Hospital and Medical Center ( Site 3605)

    Muntinlupa, National Capital Region, 1780

  • THE MEDICAL CITY-Cancer Research Center ( Site 3603)

    Pasig, National Capital Region, 1604

  • ST. LUKE'S MEDICAL CENTER ( Site 3601)

    Quezon City, National Capital Region, 1102

  • CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602)

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

Other trials in Philippines

Thailand6 sites

  • Faculty of Medicine Siriraj Hospital ( Site 4000)

    Bangkok, Bangkok, 10700

  • Songklanagarind hospital ( Site 4001)

    Hat Yai, Changwat Songkhla, 90110

  • Faculty of Medicine - Khon Kaen University ( Site 4004)

    Khon Kaen, 40002

  • Lampang Cancer Hospital ( Site 4005)

    Muang, Changwat Lampang, 52000

  • Maharaj Nakorn Chiang Mai Hospital ( Site 4003)

    Muang, Chiang Mai, 50200

  • Sunpasitthiprasong Hospital-Oncology ( Site 4002)

    Ubon Ratchathani, 34000

Other trials in Thailand

Turkey (Türkiye)6 sites

  • Adana Medical Park Seyhan Hastanesi ( Site 2506)

    Adana, 01140

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501)

    Ankara, 06800

  • Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504)

    Bornova, İzmir, 35100

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

    Istanbul, 34722

  • Medipol Mega Universite Hastanesi-oncology ( Site 2505)

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606)

    London, Kensington and Chelsea, SW3 6JJ

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

    London, London, City of, EC1A 7BE

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

    London, London, City of, SE1 9RT

  • The Christie NHS Foundation Trust ( Site 2604)

    Manchester, m20 4bx

  • The Clatterbridge Cancer Centre ( Site 2602)

    Metropolitan Borough of Wirral, CH63 4JY

  • Royal Marsden Hospital (Sutton) ( Site 2605)

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Czechia5 sites

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

    Brno, Brno-mesto, 656 53

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

    Olomouc, 779 00

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

    Ostrava, Ostrava Mesto, 703 00

  • Fakultni nemocnice Plzen ( Site 1104)

    Pilsen, Plzeň Region, 305 99

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

    Prague, 122 00

Other trials in Czechia

France5 sites

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

    Bordeaux, Aquitaine, 33076

  • CENTRE LEON BERARD ( Site 1305)

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

  • Groupe hospitalier Paris saint Joseph. ( Site 1307)

    Paris, 75014

  • Institut Curie-Thorax Institute ( Site 1304)

    Paris, 75248

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

    Rouen, Haute-Normandie, 76031

Other trials in France

Italy5 sites

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

    Meldola, Emilia-Romagna, 47014

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

    Milan, Lombardy, 20133

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

    Rome, Lazio, 00168

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

    Rome, Roma, 00144

  • Istituto Clinico Humanitas ( Site 1803)

    Rozzano, Lombardy, 20089

Other trials in Italy

Australia4 sites

  • Monash Health-Oncology Research ( Site 3001)

    Clayton, Victoria, 3168

  • St. George Private Hospital ( Site 3004)

    Kogarah, New South Wales, 2217

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

    Melbourne, Victoria, 3021

  • Westmead Hospital ( Site 3000)

    Westmead, New South Wales, 2145

Other trials in Australia

Hong Kong4 sites

  • Hong Kong Integrated Oncology Centre ( Site 3200)

    Central, 0000

  • Queen Mary Hospital ( Site 3203)

    Hksar

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

    Kowloon, 999077

  • Princess Margaret Hospital-Department of Oncology ( Site 3201)

    Lai Chi Kok

Other trials in Hong Kong

Mexico4 sites

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

    Guadalajara, Jalisco, 44630

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

    Monterrey, Nuevo León, 66460

  • Centro de Investigacion Clinica de Oaxaca ( Site 0701)

    Oaxaca City, Oaxaca, 68020

  • Clinica Integral Internacional de Oncología ( Site 0705)

    Puebla City, 72530

Other trials in Mexico

Israel3 sites

  • Rambam Health Care Campus-Oncology Division ( Site 1702)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 1700)

    Jerusalem, 9103102

  • Rabin Medical Center ( Site 1703)

    Petah Tikva, 4941492

Other trials in Israel

Malaysia3 sites

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

    Kota Bharu, Kelantan, 15586

  • Sarawak General Hospital-Radiotherapy Unit ( Site 3500)

    Kuching, Sarawak, 93586

  • National Cancer Institute-Radiotherapy and Oncology ( Site 3504)

    Putrajaya, Kuala Lumpur, 62250

Other trials in Malaysia

Vietnam3 sites

  • Hanoi Oncology Hospital ( Site 4102)

    Hanoi, Hanoi, 100000

  • K Hospital - National Cancer Hospital ( Site 4105)

    Hanoi, Hanoi, 100000

  • National Lung Hospital-Oncology Department ( Site 4104)

    Hanoi, Hanoi, 100000

Other trials in Vietnam

Canada2 sites

  • William Osler Health System ( Site 0205)

    Brampton, Ontario, L6R 3J7

  • Princess Margaret Cancer Centre ( Site 0204)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations

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 hypothesis is that sacituzumab tirumotecan is superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Being tested
Sacituzumab tirumotecan, Docetaxel, Pemetrexed
Keywords
Anaplastic lymphoma kinase (ALK), Antibody-drug conjugate (ADC), Epidermal growth factor receptor (EGFR), Trophoblast cell-surface antigen 2 (TROP2)
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.

  • Sacituzumab tirumotecanBiological

    Also called SKB264, MK-2870

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

  • DocetaxelDrug

    Also called TAXOTERE®

    75 mg/m^2 of docetaxel by IV Infusion

  • PemetrexedDrug

    Also called ALIMTA®

    500 mg/m^2 of pemetrexed by IV infusion

Study groups in NCT06074588
Study groupRoleWhat they receive
Sacituzumab tirumotecanExperimentalParticipants 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.
Receives: Biological: Sacituzumab tirumotecan
ChemotherapyActive comparatorParticipants 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.
Receives: Drug: Docetaxel; Drug: Pemetrexed

What is being measured

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

  1. Overall Survival (OS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations

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

    Measured: Up to approximately 41 months

Secondary outcomes (16)

  1. OS of All Participants with NSCLC

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

    Measured: Up to approximately 41 months

  2. Progression-free Survival (PFS) of Participants with NSCLC with EGFR Mutations

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

    Measured: Up to approximately 41 months

  3. PFS of All Participants with NSCLC

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

    Measured: Up to approximately 41 months

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

    ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR in NSCLC with EGFR mutations.

    Measured: Up to approximately 35 months

  5. ORR of All Participants with NSCLC

    ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR in all participants with NSCLC.

    Measured: Up to approximately 35 months

  6. Duration of Response (DOR) of All Participants with NSCLC

    For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR in all participants with NSCLC, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 6 years

  7. Change in Score from Baseline in Global Health Status/QoL Score (European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Items 29 and 30)

    The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

    Measured: Baseline and up to approximately 48 weeks

  8. Change in Score from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. The change from baseline in the dyspnea (EORTC QLQ-C30 Item 8) score will be presented.

    Measured: Baseline and up to approximately 48 weeks

  9. Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.

    Measured: Baseline and up to approximately 48 weeks

  10. Change in Score from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.

    Measured: Baseline and up to approximately 48 weeks

  11. Time to Deterioration (TTD) from Baseline in Global Health Status/QoL Score (EORTC QLQ-C30 Items 29 and 30)

    The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status and quality of life. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.

    Measured: Up to approximately 48 weeks

  12. TTD from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Item 8 will be presented.

    Measured: Up to approximately 48 weeks

  13. TTD from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate more frequent coughing and a worse outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-LC13 Item 31 will be presented.

    Measured: Up to approximately 48 weeks

  14. Time to Deterioration from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-LC13 Item 40 will be presented.

    Measured: Up to approximately 48 weeks

  15. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is defined as 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 approximately 6 years

  16. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

    An AE is defined as 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 approximately 4 years

Timeline

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

  1. First posted10 Oct 2023
  2. Study start12 Nov 2023
  3. Primary completion10 May 2027 (estimated)
  4. Study completion11 Mar 2030 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
556 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074588
Sponsor's protocol ID
2870-004
Other IDs
2023-503539-16-00, jRCT2031240108, U1111-1287-4913, 2023
Status last verified
Aug 2026
First submitted
3 Oct 2023
Last updated
14 Aug 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab tirumotecan, Docetaxel and Pemetrexed in people with Non-small Cell Lung Cancer (NSCLC), run by Merck Sharp & Dohme LLC at 195 sites in 25 countries.

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 9 inclusion and 20 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in China, Japan, United States, South Korea, Taiwan and 20 more countries. 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 phase mean?

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 (OS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations (time frame: Up to approximately 41 months). 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 NCT06074588.

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 14 Aug 2026.

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