AzTrials
AzTrials

Non-small Cell Lung Cancer (NSCLC)Phase 3NCT06305754

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Phase 3 study testing Sacituzumab tirumotecan, Pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer (NSCLC), run by Merck Sharp & Dohme LLC at 156 sites in 19 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). 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, Pemetrexed and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
156 sitesin 19 countries
Study dates
11 Jun 2024to 14 Jun 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 confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC).
  • Participants who have adverse events (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 Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.
  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
  • Life expectancy of at least 3 months.

Who cannot join

  • Predominantly squamous cell histology NSCLC.
  • History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
  • Grade ≥2 peripheral neuropathy.
  • 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.
  • Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
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  • 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. Administration of killed vaccines are allowed.
  • Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • Active infection requiring systemic therapy.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Concurrent active HBV and HCV infection.
  • History of allogeneic tissue/solid organ transplant.
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Trial locations and contacts

156 sites in 19 countries.

156 sites in 19 countries

China26 sites

  • Beijing Cancer hospital ( Site 3100)

    Beijing, Beijing Municipality, 100142

  • Beijing Peking Union Medical College Hospital-pneumology department ( Site 3107)

    Beijing, Beijing Municipality, 100730

  • The Second Xiangya Hospital of Central South University-Oncology ( Site 3104)

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University ( Site 3126)

    Chengdu, Sichuan, 610041

  • Sichuan Cancer hospital. ( Site 3127)

    Chengdu, Sichuan, 610042

  • Chongqing University Cancer Hospital-Medical Oncology ( Site 3128)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Cancer Hospital ( Site 3124)

    Fuzhou, Fujian, 350014

  • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3102)

    Guangzhou, Guangdong, 510515

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3101)

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 3106)

    Hangzhou, Zhejiang, 310016

  • Harbin Medical University Cancer Hospital ( Site 3109)

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Cancer Hospital ( Site 3132)

    Hefei, Anhui, 230031

  • Jinan Central Hospital ( Site 3113)

    Jinan, Shandong, 250013

  • Shandong Cancer Hospital ( Site 3112)

    Jinan, Shandong, 250117

  • The Second Affiliated Hospital of Nanchang University ( Site 3119)

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 3117)

    Nanjing, Jiangsu, 210031

  • Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103)

    Nanning, Guangxi, 530021

  • Zhongshan Hospital of Fudan University ( Site 3133)

    Shanghai, Shanghai Municipality, 200032

  • The First Affiliated Hospital of Soochow University-Respiratory Department ( Site 3118)

    Suzhou, Jiangsu, 215006

  • Shanxi Cancer Hospital ( Site 3114)

    Taiyuan, Shanxi, 410013

  • The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 3120)

    Wenzhou, Zhejiang, 325015

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 3121)

    Wuhan, Hubei, 430000

  • Hubei Cancer Hospital ( Site 3122)

    Wuhan, Hubei, 430079

  • The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 3130)

    Xi'an, Shaanxi, 710004

  • The First Affiliated hospital of Xiamen University ( Site 3125)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital ( Site 3105)

    Zhengzhou, Henan, 450008

Other trials in China

Japan19 sites

  • National Cancer Center Hospital ( Site 3408)

    Chūō, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center ( Site 3401)

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital ( Site 3400)

    Fukuoka, 812-8582

  • Kansai Medical University Hospital ( Site 3414)

    Hirakata, Osaka, 573-1191

  • Hiroshima City Hiroshima Citizens Hospital ( Site 3419)

    Hiroshima, 730-8518

  • Kanazawa University Hospital ( Site 3402)

    Kanazawa, Ishikawa-ken, 920-8641

  • St. Marianna University Hospital ( Site 3415)

    Kawasaki, Kanagawa, 216-8511

  • Saitama Prefectural Cancer Center ( Site 3417)

    Kitaadachi-gun, Saitama, 362-0806

  • Miyagi Cancer Center ( Site 3406)

    Natori-shi, Miyagi, 981-1293

  • Niigata Cancer Center Hospital ( Site 3403)

    Niigata, 951-8566

  • Okayama University Hospital ( Site 3404)

    Okayama, 700-8558

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3410)

    Osaka, 541-8567

  • Osaka Metropolitan University Hospital ( Site 3412)

    Osaka, 545-0051

  • Gunma Prefectural Cancer Center ( Site 3413)

    Ōta, Gunma, 373-8550

  • Toho University Omori Medical Center ( Site 3407)

    Ōta-ku, Tokyo, 143-8541

  • Shizuoka Cancer Center ( Site 3405)

    Sunto-gun, Shizuoka, 411-8777

  • Ehime University Hospital ( Site 3411)

    Tōon, Ehime, 791-0295

  • Fujita Health University Hospital ( Site 3409)

    Toyoake, Aichi-ken, 470-1192

  • Kanagawa Cancer Center ( Site 3416)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States17 sites

  • University of Michigan ( Site 0009)

    Ann Arbor, Michigan, 48109

  • Astera Cancer Care ( Site 0032)

    East Brunswick, New Jersey, 08816

  • Sanford Fargo Medical Center ( Site 0028)

    Fargo, North Dakota, 58122

  • John Peter Smith Hospital ( Site 0065)

    Fort Worth, Texas, 76104

  • University of Texas MD Anderson ( Site 0063)

    Houston, Texas, 77030

  • Millennium Research & Clinical Development ( Site 0035)

    Houston, Texas, 77090

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

    Marietta, Georgia, 30060

  • Kaiser Permanente - Oakland ( Site 0054)

    Oakland, California, 94611

  • Mid Florida Hematology and Oncology Center ( Site 0005)

    Orange City, Florida, 32763

  • Kaiser Permanente - Roseville ( Site 0055)

    Roseville, California, 95661

  • Kaiser Permanente - San Francisco ( Site 0056)

    San Francisco, California, 94115

  • Kaiser Permanente - Santa Clara ( Site 0057)

    Santa Clara, California, 95051

  • Sanford Cancer Center ( Site 0024)

    Sioux Falls, South Dakota, 57104

  • Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051)

    Springfield, Missouri, 65807

  • Stony Brook University-Cancer Center ( Site 0038)

    Stony Brook, New York, 11794

  • Kaiser Permanente-Kaiser Permanente ( Site 0036)

    Vallejo, California, 94589

  • Kaiser Permanente - Walnut Creek ( Site 0058)

    Walnut Creek, California, 94596

Other trials in United States

South Korea13 sites

  • Pusan National University Hospital ( Site 3805)

    Busan, Pusan-Kwangyokshi, 49241

  • Chungbuk National University Hospital ( Site 3804)

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Hospital CRC room 1 ( Site 3814)

    Daegu, Taegu-Kwangyokshi, 42601

  • National Cancer Center ( Site 3803)

    Goyang-si, Kyonggi-do, 10408

  • Chungnam national university hospital ( Site 3806)

    Junggu, Taejon-Kwangyokshi, 35015

  • Pusan National University Yangsan Hospital ( Site 3802)

    Pusan, Kyongsangnam-do, 50612

  • Seoul National University Bundang Hospital ( Site 3807)

    Seongnam, Kyonggi-do, 13620

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3812)

    Seoul, 03312

  • Asan Medical Center ( Site 3810)

    Seoul, 05505

  • Samsung Medical Center ( Site 3811)

    Seoul, 06351

  • Korea University Guro Hospital ( Site 3808)

    Seoul, 08308

  • The Catholic University Of Korea St. Vincent's Hospital ( Site 3800)

    Suwon, Kyonggi-do, 16247

  • Ajou University Hospital ( Site 3813)

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Taiwan12 sites

  • Changhua Christian Hospital ( Site 3904)

    Changhua, 50006

  • National Taiwan University Hospital - Hsinchu branch ( Site 3900)

    Hsinchu, 300

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)

    Kaohsiung City, 83301

  • Far Eastern Memorial Hospital ( Site 3912)

    New Taipei City, 220

  • Taichung Veterans General Hospital-Chest ( Site 3910)

    Taichung, 40705

  • National Cheng Kung University Hospital ( Site 3901)

    Tainan, Tainan, 704

  • Chi Mei Hospital - Liouying Branch ( Site 3909)

    Tainan, Tainan, 73657

  • National Taiwan University Hospital-Oncology ( Site 3908)

    Taipei, 10002

  • Mackay Memorial Hospital-Chest Medicine ( Site 3902)

    Taipei, 10449

  • Taipei Medical University Hospital ( Site 3903)

    Taipei, 110301

  • National Taiwan University Cancer Center (NTUCC) ( Site 3907)

    Taipei City, Taipei, 106

  • Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 3911)

    Taoyuan, 333

Other trials in Taiwan

Thailand7 sites

  • Faculty of Medicine Siriraj Hospital ( Site 4004)

    Bangkok, Bangkok, 10700

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 4006)

    Dusit, Bangkok, 10300

  • Songklanagarind hospital ( Site 4003)

    Hat Yai, Changwat Songkhla, 90110

  • Lampang Cancer Hospital ( Site 4000)

    Lampang, Changwat Lampang, 52000

  • Faculty of Medicine - Khon Kaen University ( Site 4002)

    Muang, Changwat Khon Kaen, 40002

  • Maharaj Nakorn Chiang Mai Hospital ( Site 4005)

    Muang, Chiang Mai, 50200

  • Ramathibodi Hospital ( Site 4001)

    Ratchathewi, Changwat Ratchaburi, 10400

Other trials in Thailand

Vietnam7 sites

  • Hanoi Oncology Hospital ( Site 4198)

    Hanoi, Hanoi, 100000

  • K Hospital - National Cancer Hospital ( Site 4193)

    Hanoi, Hanoi, 100000

  • National Lung Hospital-Oncology Department ( Site 4194)

    Hanoi, Hanoi, 100000

  • Oncology Hospital ( Site 4191)

    Ho Chi Minh City, Ho Chi Minh, 700000

  • Cho Ray Hospital ( Site 4190)

    Ho Chi Minh City, 700000

  • Tam Anh TP.HCM General Hospital ( Site 4196)

    Ho Chi Minh City, 700000

  • Thong Nhat Hospital ( Site 4192)

    Tan Binh District, Ho Chi Minh, 700000

Other trials in Vietnam

Argentina6 sites

  • Hospital Británico de Buenos Aires-Oncology ( Site 0304)

    Buenos Aires, Buenos Aires F.D., C1280AEB

  • Clinica Adventista Belgrano-Oncology ( Site 0315)

    Caba., Buenos Aires, C1430EGF

  • Instituto Alexander Fleming ( Site 0307)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303)

    La Rioja, F5300COE

  • Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)

    Río Cuarto, Córdoba Province, X5800ALB

  • Instituto de Oncología de Rosario ( Site 0301)

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

Colombia6 sites

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)

    Bogotá, Bogota D.C., 110131

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0606)

    Bogotá, Bogota D.C., 111321

  • Fundacion Valle del Lili- CIC-Oncology CIC ( Site 0605)

    Cali, Valle del Cauca Department, 760032

  • IMAT S.A.S ( Site 0602)

    Montería, Departamento de Córdoba, 230002

  • Oncologos del Occidente ( Site 0604)

    Pereira, Risaralda Department, 660001

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0601)

    Valledupar, Cesar Department, 200002

Other trials in Colombia

India6 sites

  • Artemis hospital ( Site 3307)

    Gurugram, Haryana, 122001

  • Tata Memorial Hospital-Medical Oncology ( Site 3304)

    Mumbai, Maharashtra, 400012

  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 3302)

    Mumbai, Maharashtra, 400053

  • All India Institute of Medical Sciences-Department of medical oncology ( Site 3303)

    New Delhi, National Capital Territory of Delhi, 110029

  • Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3301)

    New Delhi, National Capital Territory of Delhi, 110076

  • Rajiv Gandhi Cancer Institute And Research Centre ( Site 3300)

    New Delhi, National Capital Territory of Delhi, 110085

Other trials in India

Italy5 sites

  • Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1802)

    Bari, Apulia, 70124

  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1804)

    Florence, Tuscany, 50134

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

    Milan, Lombardy, 20133

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1803)

    Milan, Lombardy, 20141

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)

    Roma, 00168

Other trials in Italy

Malaysia5 sites

  • Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 3501)

    George Town, Pulau Pinang, 10450

  • Hospital Tengku Ampuan Afzan ( Site 3506)

    Kuantan, Pahang, 25100

  • Sarawak General Hospital-Radiotherapy Unit ( Site 3508)

    Kuching, Sarawak, 93586

  • University Malaya Medical Centre ( Site 3507)

    Lembah Pantai, Kuala Lumpur, 59100

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

    Putrajaya, Kuala Lumpur, 62250

Other trials in Malaysia

Mexico5 sites

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0700)

    Guadalajara, Jalisco, 44630

  • Arké SMO S.A. de C.V. ( Site 0706)

    Mexico City, Mexico City, 06700

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0705)

    Monterrey, Nuevo León, 64460

  • Oaxaca Site Management Organization S.C. ( Site 0701)

    Oaxaca City, 68000

  • Centro de Investigacion Clinica de Oaxaca ( Site 0704)

    Oaxaca City, 68020

Other trials in Mexico

Turkey (Türkiye)5 sites

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2504)

    Adana, 01140

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)

    Ankara, 06230

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)

    Ankara, 06520

  • Ankara Bilkent Şehir Hastanesi ( Site 2500)

    Ankara, 06800

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 2503)

    Izmir, 35575

Other trials in Turkey (Türkiye)

Canada4 sites

  • Cross Cancer Institute ( Site 0201)

    Edmonton, Alberta, T6G 1Z2

  • Waterloo Regional Health Network (WRHN) ( Site 0207)

    Kitchener, Ontario, N2G 1G3

  • McGill University Health Centre ( Site 0204)

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Centre ( Site 0203)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

France4 sites

  • Clinique Clairval ( Site 1306)

    Marseille, Bouches-du-Rhone, 13009

  • Hopitaux Universitaires Paris Centre-Hopital Cochin-Unité d'Oncologie Thoracique ( Site 1304)

    Paris, 75014

  • Nouvel Hôpital Civil (NHC) ( Site 1302)

    Strasbourg, Alsace, 67091

  • Gustave Roussy ( Site 1303)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Poland4 sites

  • Bialostockie Centrum Onkologii ( Site 2010)

    Bialystok, Podlaskie Voivodeship, 15-027

  • 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

  • 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

Spain4 sites

  • Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2323)

    Huelva, 21005

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2321)

    LHospitalet de Llobregat, Barcelona, 08908

  • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2322)

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2324)

    Seville, 41009

Other trials in Spain

Sweden1 site

  • Karolinska Universitetssjukhuset Solna ( Site 2401)

    Stockholm, Stockholm County, 171 64

Other trials in Sweden

About this study

Official title: A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs).

The primary hypotheses of this study is that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to overall survival (OS).

Read the detailed description

Participants will be randomized 1:1 into two arms:

  • Sacituzumab tirumotecan
  • Pemetrexed plus Carboplatin

Participants will receive treatment until any of the criteria for discontinuation of study intervention are met.

Being tested
Sacituzumab tirumotecan, Pemetrexed, Carboplatin, H1 Receptor Antagonist, H2 Receptor Antagonist
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 via IV infusion

  • PemetrexedDrug

    500 mg/m^2 via IV infusion

  • CarboplatinDrug

    AUC 5 mg/mL*min via IV infusion

  • H1 Receptor AntagonistDrug

    Administered as rescue medication per approved product label

  • H2 Receptor AntagonistDrug

    Administered as rescue medication per approved product label

  • Acetaminophen (or equivalent)Drug

    Administered as rescue medication per approved product label

  • Dexamethasone (or equivalent)Drug

    Administered as rescue medication per approved product label

  • Steroid Mouthwash (dexamethasone or equivalent)Drug

    Administered as rescue medication per approved product label

Study groups in NCT06305754
Study groupRoleWhat they receive
Sacituzumab tirumotecanExperimentalParticipants receive 4 mg/kg sacituzumab tirumotecan via intravenous (IV) infusion every 2 weeks (Days 1, 15, and 29 of every 6-week cycle) until discontinuation criteria is met.
Receives: Biological: Sacituzumab tirumotecan; Drug: H1 Receptor Antagonist; Drug: H2 Receptor Antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid Mouthwash (dexamethasone or equivalent)
Pemetrexed Plus CarboplatinActive comparatorParticipants receive, via IV infusion, 500 mg/m2 pemetrexed every 3 weeks (Days 1 and 22 of every 6-week cycle) plus area under the curve (AUC) 5 mg/mL*min carboplatin every 3 weeks (Days 1 and 22 of every 6-week cycle for 4 doses), then 500 mg/m2 pemetrexed every 3 weeks until discontinuation criteria is met.
Receives: Drug: Pemetrexed; Drug: Carboplatin

What is being measured

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

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death due to any cause. Overall survival for all randomized participants will be reported.

    Measured: Up to approximately 51 months

Secondary outcomes (13)

  1. Progression-Free Survival (PFS)

    Progression-Free Survival is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PFS for all randomized participants will be reported.

    Measured: Up to approximately 51 months

  2. Objective Response Rate (ORR)

    The objective response rate (ORR) is defined as a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR. The overall response rate for all randomized participants will be reported.

    Measured: Up to approximately 51 months

  3. Duration of Response (DOR)

    For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response 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. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Up to approximately 51 months

  4. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) 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 value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be reported.

    Measured: Baseline and up to approximately 6 years

  5. Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" 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. A higher value indicates increased severity of symptoms. Change from baseline in dyspnea (EORTC QLQ-C30 Item 8) will be reported.

    Measured: Baseline and up to approximately 6 years

  6. Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13)

    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. A higher value indicates increased severity of symptoms. Change from baseline in cough (EORTC QLQ-LC13 Item 31) will be reported.

    Measured: Baseline and up to approximately 6 years

  7. Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13

    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. A higher value indicates increased severity of symptoms. Change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented.

    Measured: Baseline and up to approximately 6 years

  8. Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30

    EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Items 29 and 30 ("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. TTD in Global Health Status (GHS)/Quality of Life (QoL) is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in combined GHS/QoL score. The TTD in GHS/QoL (Items 29 and 30) combined score will be reported.

    Measured: Baseline and up to approximately 6 years

  9. TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30

    EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the question for Item 8 "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). TTD is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in score. The TTD in dyspnea score (EORTC QLQ-C30 Item 8) will be reported.

    Measured: Baseline and up to approximately 6 years

  10. TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question for Item 31 "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). TTD is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in score. The TTD in cough score (EORTC QLQ-C30 Item 31) will be reported.

    Measured: Baseline and up to approximately 6 years

  11. TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question for Item 40 "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. TTD is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in score. The TTD in chest pain score (EORTC QLQ-C30 Item 40) will be reported.

    Measured: Baseline and up to approximately 6 years

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

    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. The number of participants who experience one or more AEs will be reported.

    Measured: Up to approximately 6 years

  13. Number of Participants Who Discontinue Study Treatment Due to an 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. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 6 years

Timeline

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

  1. First posted12 Mar 2024
  2. Study start11 Jun 2024
  3. Primary completion17 Aug 2028 (estimated)
  4. Study completion14 Jun 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
Single blind
Who is masked
Outcomes assessor
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305754
Sponsor's protocol ID
2870-009
Other IDs
2023-504910-31-00, U1111-1288-3804, MK-2870-009, jRCT2071240041, 2023
Status last verified
Oct 2026
First submitted
5 Mar 2024
Last updated
30 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab tirumotecan, Pemetrexed and Carboplatin in people with Non-small Cell Lung Cancer (NSCLC), run by Merck Sharp & Dohme LLC at 156 sites in 19 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 6 inclusion and 16 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in China, Japan, United States, South Korea, Taiwan and 14 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) (time frame: Up to approximately 51 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 NCT06305754.

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 30 Oct 2026.

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