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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07227597

Registry updated: 2026-10-20
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Description

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

Interventions

  • Gocatamig (Drug)
    Intravenous (IV) administration
  • I-DXd (Drug)
    IV administration
  • Atezolizumab (Drug)
    IV administration
  • Carboplatin (Drug)
    IV administration
  • Etoposide (Drug)
    IV administration
  • Rescue Medications (Drug)
    Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.

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

Conditions

Small Cell Lung Cancer Extensive Stage

Locations

  • Providence Medical Foundation ( Site 0124) — Santa Rosa, California, United States
  • University of Colorado, Anschutz Cancer Pavilion ( Site 0125) — Aurora, Colorado, United States
  • Orlando Health Cancer Institute ( Site 0108) — Orlando, Florida, United States
  • Saint Elizabeth Medical Center Edgewood ( Site 0112) — Edgewood, Kentucky, United States
  • Washington University School of Medicine ( Site 0134) — St Louis, Missouri, United States
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101) — Hackensack, New Jersey, United States
  • Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107) — Portland, Oregon, United States
  • Avera Cancer Institute- Research ( Site 0104) — Sioux Falls, South Dakota, United States
  • The University of Tennessee Medical Center ( Site 0120) — Knoxville, Tennessee, United States
  • Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133) — Memphis, Tennessee, United States
  • SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee, United States
  • Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113) — Houston, Texas, United States
  • University of Virginia Health System ( Site 0122) — Charlottesville, Virginia, United States
  • CEMIC ( Site 1903) — Caba., Buenos Aires, Argentina
  • Hospital Austral ( Site 1901) — Pilar, Buenos Aires, Argentina
  • Sanatorio Parque ( Site 1900) — Rosario, Santa Fe Province, Argentina
  • Fundación Arturo López Pérez ( Site 0200) — Santiago, Region M. de Santiago, Chile
  • Pontificia Universidad Catolica de Chile ( Site 0202) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 0201) — Santiago, Region M. de Santiago, Chile
  • Beijing Cancer Hospital ( Site 1604) — Beijing, Beijing Municipality, China
  • Fujian Provincial Cancer Hospital ( Site 1607) — Fuzhou, Fujian, China
  • Southern Medical University Nanfang Hospital ( Site 1608) — Guangzhou, Guangdong, China
  • Jiangmen Central Hospital ( Site 1611) — Jiangmen, Guangdong, China
  • Harbin Medical University Cancer Hospital ( Site 1606) — Harbin, Heilongjiang, China
  • The First Affiliated Hospital of Nanchang University ( Site 1610) — Nanchang, Jiangxi, China
  • Shanghai East Hospital ( Site 1600) — Shanghai, Shanghai Municipality, China
  • Sichuan Cancer hospital. ( Site 1609) — Chengdu, Sichuan, China
  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602) — Hangzhou, Zhejiang, China
  • Taizhou Hospital of Zhejiang Province ( Site 1601) — Taizhou, Zhejiang, China
  • Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne ( Site 0401) — Tübingen, Baden-Wurttemberg, Germany
  • Universitaetsklinikum Jena ( Site 0403) — Jena, Thuringia, Germany
  • Errikos Dunant Hospital Center ( Site 0501) — Athens, Attica, Greece
  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0502) — Athens, Attica, Greece
  • Athens Medical Center ( Site 0504) — Athens, Attica, Greece
  • University General Hospital of Heraklion ( Site 0503) — Heraklion, Irakleio, Greece
  • European Interbalkan Medical Center ( Site 0500) — Thessaloniki, Greece
  • European Interbalkan Medical Center ( Site 0505) — Thessaloniki, Greece
  • Rambam Health Care Campus ( Site 0602) — Haifa, Israel
  • Sheba Medical Center ( Site 0601) — Ramat Gan, Israel
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702) — Meldola, Forli-Cesena, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701) — Milan, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700) — Roma, Italy
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0902) — Warsaw, Masovian Voivodeship, Poland
  • Seoul National University Hospital ( Site 1402) — Seoul, South Korea
  • Severance Hospital Yonsei University Health System ( Site 1403) — Seoul, South Korea
  • Asan Medical Center ( Site 1404) — Seoul, South Korea
  • Samsung Medical Center ( Site 1401) — Seoul, South Korea
  • Hospital San Pedro ( Site 1004) — Logroño, La Rioja, Spain
  • Hospital Universitario Insular de Gran Canaria ( Site 1002) — Las Palmas de Gran Canaria, Las Palmas, Spain
  • Hospital Universitari Vall d'Hebron ( Site 1001) — Barcelona, Spain
  • Hospital Universitario Gregorio Maranon ( Site 1003) — Madrid, Spain
  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002) — Bangkok, Bangkok, Thailand
  • Faculty of Medicine Siriraj Hospital ( Site 3000) — Bangkoknoi, Bangkok, Thailand
  • Songklanagarind hospital ( Site 3001) — Hat Yai, Changwat Songkhla, Thailand
  • Adana City Hospital ( Site 1202) — Adana, Turkey (Türkiye)
  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1200) — Ankara, Turkey (Türkiye)
  • Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 1201) — Ankara, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record