RecruitingPhase 1Phase 2NCT07227597

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

170 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two drugs — gocatamig and ifinatamab deruxtecan (an antibody-drug conjugate) — as a treatment for people with extensive-stage small cell lung cancer (ES-SCLC), both as a first-line therapy and as a maintenance treatment after initial chemotherapy. **You may be eligible if...** - You have confirmed extensive-stage small cell lung cancer - Depending on the treatment group, you may have completed 3-4 cycles of standard platinum/etoposide chemotherapy with immunotherapy (for the maintenance-only arm), or you may be treatment-naive (for the induction arms) - Your cancer has not progressed on initial therapy (for maintenance group) - You have measurable disease on imaging - Tumor tissue is available for testing **You may NOT be eligible if...** - You have received prior systemic therapy for ES-SCLC (for most arms) - Your cancer has come back after another treatment (rechallenge therapy is an exclusion) - You do not have adequate tissue available for analysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGocatamig

Intravenous (IV) administration

DRUGI-DXd

IV administration

DRUGAtezolizumab

IV administration

DRUGCarboplatin

IV administration

DRUGEtoposide

IV administration

DRUGRescue Medications

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.


Locations(15)

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

Avera Cancer Institute- Research ( Site 0104)

Sioux Falls, South Dakota, United States

The University of Tennessee Medical Center ( Site 0120)

Knoxville, Tennessee, United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, United States

Beijing Cancer Hospital ( Site 1604)

Beijing, Beijing Municipality, China

Shanghai East Hospital ( Site 1600)

Shanghai, Shanghai Municipality, China

Taizhou Hospital of Zhejiang Province ( Site 1601)

Taizhou, Zhejiang, China

Rambam Health Care Campus ( Site 0602)

Haifa, Israel

Sheba Medical Center ( Site 0601)

Ramat Gan, Israel

Seoul National University Hospital ( Site 1402)

Seoul, South Korea

Asan Medical Center ( Site 1404)

Seoul, South Korea

Samsung Medical Center ( Site 1401)

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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