Tests gocatamig and I-DXd in adults with lung cancer that returned

Trial details

Who runs it

Merck Sharp & Dohme LLC

Trial code

NCT06780137EU 2024-517926-25-00

Record updated

6 October 2026

Original description

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.Read full original descriptionShow less

A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.

The goals of this study are to learn:

* If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away

Inclusion: Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy; Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample; Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).

Exclusion: History within 6 months before the first dose of study intervention 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) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia; History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention; Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids; Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention; Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention; Part 1 only: Abdominal radiation within 4 weeks before start of study intervention; Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention; Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer; Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention; Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention; Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids; Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out; Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses; Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART; Active clinically significant infection requiring systemic therapy; History of allogeneic tissue/solid organ transplant; History of leptomeningeal disease; Known additional malignancy that is progressing or has required active treatment within the past 3 years; Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible; Part 1 only: Clinically significant corneal disease; Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease; Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure; Untreated or symptomatic brain metastases.

ClinicalTrials.gov NCT06780137 · EU CTIS 2024-517926-25-00