A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
Recruiting now · Phase 1/Phase 2
Conditions studied: Small Cell Lung Cancer
In brief
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
Key facts
- Study ID
- NCT06780137
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 327
- Starts
- 2025-02-27
- Expected to finish
- 2029-04-27
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
- 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
- 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
- Active clinically significant infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
- History of leptomeningeal disease
- 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
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Untreated or symptomatic brain metastases
- 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: 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
- Part 1 only: Clinically significant corneal disease
- Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
Where it is running
- The Christie NHS Foundation Trust ( Site 3901) — Manchester, United Kingdom (enrolling)
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) — Miami, Florida, United States (enrolling)
- University of Chicago ( Site 1108) — Chicago, Illinois, United States (enrolling)
- Dana Farber Cancer Institute ( Site 1105) — Boston, Massachusetts, United States (enrolling)
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) — Hackensack, New Jersey, United States (enrolling)
- Roswell Park Cancer Institute ( Site 1107) — Buffalo, New York, United States (enrolling)
- Providence Portland Medical Center ( Site 1101) — Portland, Oregon, United States (enrolling)
- Sarah Cannon Research Institute ( Site 7001) — Nashville, Tennessee, United States (enrolling)
- Medical College of Wisconsin ( Site 1112) — Milwaukee, Wisconsin, United States (enrolling)
- Hospital Universitario Austral ( Site 2204) — Pilar, Buenos Aires, Argentina (enrolling)
- Sanatorio Parque ( Site 2203) — Rosario, Santa Fe Province, Argentina (enrolling)
- Princess Alexandra Hospital ( Site 5300) — Woolloongabba, Queensland, Australia (enrolling)
- Monash Health ( Site 5301) — Clayton, Victoria, Australia (enrolling)
- FALP ( Site 2100) — Santiago, Region M. de Santiago, Chile (enrolling)
- Pontificia Universidad Catolica de Chile ( Site 2102) — Santiago, Region M. de Santiago, Chile (enrolling)
- Bradfordhill ( Site 2101) — Santiago, Region M. de Santiago, Chile (enrolling)
- Beijing Cancer Hospital ( Site 5401) — Beijing, Beijing Municipality, China (enrolling)
- Fujian Cancer Hospital ( Site 5413) — Fuzhou, Fujian, China (enrolling)
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403) — Nanjing, Jiangsu, China (enrolling)
- Shanghai Chest Hospital ( Site 5400) — Shanghai, Shanghai Municipality, China (enrolling)
- Shanghai Pulmonary Hospital ( Site 5405) — Shanghai, Shanghai Municipality, China (enrolling)
- West China Hospital of Sichuan University ( Site 5416) — Chengdu, Sichuan, China (enrolling)
- The First Affiliated Hospital, Zhejiang University ( Site 5404) — Hangzhou, Zhejiang, China (enrolling)
- University of Colorado Anschutz Medical Campus ( Site 1110) — Aurora, Colorado, United States (enrolling)
- Shaare Zedek Medical Center ( Site 3200) — Jerusalem, Israel (enrolling)
Full record on ClinicalTrials.gov
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