A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer
- Small Cell Lung Cancer Extensive Stage
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 170
- Started
- 29 January 2026
- Main results due
- 29 November 2030
- Study sites
- 53
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) * For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only: * Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1/Ligand 1 (anti PD-1/L1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment * No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) * No other prior systemic ES-SCLC therapy allowed * Rechallenge therapy counts as an additional line and leads to exclusion * For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed * Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if \> 6 months have passed since the end of previous therapy and progression * Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated * Measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Has history of clinically significant intracranial bleeding or spinal cord bleeding * Has active neurologic paraneoplastic syndrome * Has history of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF), and/or uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention * Has other uncontrolled or significant protocol specified cardiovascular disease * Has history of arterial thrombosis within 6 months before the first dose of study intervention * Has chronic liver disease * Has history of allogeneic tissue/solid organ transplant * Has history of leptomeningeal disease * Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation/randomization (or first dose), or is anticipated to require a major surgical procedure during the study
What this study is about
In the sponsor’s own words, from the registry.
Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.
A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.
* Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing. * Immunotherapy is a treatment that helps the immune system fight cancer.
Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.
* T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells. * A T-cell is a type of white blood cell, which are cells that help the body fight infection. * An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goals of this study are to learn:
* About the safety of combining gocatamig and I-DXd and if people tolerate them together * If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away
Study sites(53)
Providence Medical Foundation ( Site 0124)
Santa Rosa, California, United States
Recruiting
University of Colorado, Anschutz Cancer Pavilion ( Site 0125)
Aurora, Colorado, United States
Recruiting
Orlando Health Cancer Institute ( Site 0108)
Orlando, Florida, United States
Recruiting
Saint Elizabeth Medical Center Edgewood ( Site 0112)
Edgewood, Kentucky, United States
Recruiting
Washington University School of Medicine ( Site 0134)
St Louis, Missouri, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)
Hackensack, New Jersey, United States
Recruiting
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)
Portland, Oregon, United States
Recruiting
Avera Cancer Institute- Research ( Site 0104)
Sioux Falls, South Dakota, United States
Recruiting
The University of Tennessee Medical Center ( Site 0120)
Knoxville, Tennessee, United States
Recruiting
Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)
Memphis, Tennessee, United States
Recruiting
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States
Recruiting
Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)
Houston, Texas, United States
Recruiting
University of Virginia Health System ( Site 0122)
Charlottesville, Virginia, United States
Recruiting
CEMIC ( Site 1903)
Caba., Buenos Aires, Argentina
Recruiting
Hospital Austral ( Site 1901)
Pilar, Buenos Aires, Argentina
Recruiting
Sanatorio Parque ( Site 1900)
Rosario, Santa Fe Province, Argentina
Recruiting
FALP ( Site 0200)
Santiago, Region M. de Santiago, Chile
Recruiting
Pontificia Universidad Catolica de Chile ( Site 0202)
Santiago, Region M. de Santiago, Chile
Recruiting
Bradfordhill ( Site 0201)
Santiago, Region M. de Santiago, Chile
Recruiting
Beijing Cancer Hospital ( Site 1604)
Beijing, Beijing Municipality, China
Recruiting
Fujian Provincial Cancer Hospital ( Site 1607)
Fuzhou, Fujian, China
Recruiting
Southern Medical University Nanfang Hospital ( Site 1608)
Guangzhou, Guangdong, China
Recruiting
Jiangmen Central Hospital ( Site 1611)
Jiangmen, Guangdong, China
Recruiting
Harbin Medical University Cancer Hospital ( Site 1606)
Harbin, Heilongjiang, China
Recruiting
The First Affiliated Hospital of Nanchang University ( Site 1610)
Nanchang, Jiangxi, China
Recruiting
Shanghai East Hospital ( Site 1600)
Shanghai, Shanghai Municipality, China
Recruiting
Sichuan Cancer hospital. ( Site 1609)
Chengdu, Sichuan, China
Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)
Hangzhou, Zhejiang, China
Recruiting
Taizhou Hospital of Zhejiang Province ( Site 1601)
Taizhou, Zhejiang, China
Recruiting
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne ( Site 0401)
Tübingen, Baden-Wurttemberg, Germany
Recruiting
Universitaetsklinikum Jena ( Site 0403)
Jena, Thuringia, Germany
Recruiting
Errikos Dunant Hospital Center ( Site 0501)
Athens, Attica, Greece
Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0502)
Athens, Attica, Greece
Recruiting
Athens Medical Center ( Site 0504)
Athens, Attica, Greece
Recruiting
European Interbalkan Medical Center ( Site 0500)
Thessaloniki, Greece
Recruiting
European Interbalkan Medical Center ( Site 0505)
Thessaloniki, Greece
Recruiting
Rambam Health Care Campus ( Site 0602)
Haifa, Israel
Recruiting
Sheba Medical Center ( Site 0601)
Ramat Gan, Israel
Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702)
Meldola, Forli-Cesena, Italy
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701)
Milan, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700)
Roma, Italy
Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0902)
Warsaw, Masovian Voivodeship, Poland
Recruiting
Seoul National University Hospital ( Site 1402)
Seoul, South Korea
Recruiting
Severance Hospital Yonsei University Health System ( Site 1403)
Seoul, South Korea
Recruiting
Asan Medical Center ( Site 1404)
Seoul, South Korea
Recruiting
Samsung Medical Center ( Site 1401)
Seoul, South Korea
Recruiting
Hospital San Pedro ( Site 1004)
Logroño, La Rioja, Spain
Recruiting
Hospital Universitario Insular de Gran Canaria ( Site 1002)
Las Palmas de Gran Canaria, Las Palmas, Spain
Recruiting
Hospital Universitari Vall d'Hebron ( Site 1001)
Barcelona, Spain
Recruiting
Hospital Universitario Gregorio Maranon ( Site 1003)
Madrid, Spain
Recruiting
Faculty of Medicine Siriraj Hospital ( Site 3000)
Bangkoknoi, Bangkok, Thailand
Recruiting
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)
Dusit, Bangkok, Thailand
Recruiting
Songklanagarind hospital ( Site 3001)
Hat Yai, Changwat Songkhla, Thailand
Recruiting
Showing 53 of 53 sites. 53 of the 53 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07227597. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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