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

Recruiting now · Phase 1/Phase 2

Conditions studied: Small Cell Lung Cancer Extensive Stage

In brief

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

Key facts

Study ID

NCT07227597

Run by

Merck Sharp & Dohme LLC

People needed

170

Starts

2026-01-29

Expected to finish

2030-12-30

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence Medical Foundation ( Site 0124) — Santa Rosa, California, United States (enrolling)
• University of Colorado, Anschutz Cancer Pavilion ( Site 0125) — Aurora, Colorado, United States (enrolling)
• Orlando Health Cancer Institute ( Site 0108) — Orlando, Florida, United States (enrolling)
• Saint Elizabeth Medical Center Edgewood ( Site 0112) — Edgewood, Kentucky, United States (enrolling)
• Washington University School of Medicine ( Site 0134) — St Louis, Missouri, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101) — Hackensack, New Jersey, United States (enrolling)
• Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107) — Portland, Oregon, United States (enrolling)
• Avera Cancer Institute- Research ( Site 0104) — Sioux Falls, South Dakota, United States (enrolling)
• The University of Tennessee Medical Center ( Site 0120) — Knoxville, Tennessee, United States (enrolling)
• Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133) — Memphis, Tennessee, United States (enrolling)
• SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee, United States (enrolling)
• Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113) — Houston, Texas, United States (enrolling)
• University of Virginia Health System ( Site 0122) — Charlottesville, Virginia, United States (enrolling)
• CEMIC ( Site 1903) — Caba., Buenos Aires, Argentina (enrolling)
• Hospital Austral ( Site 1901) — Pilar, Buenos Aires, Argentina (enrolling)
• Sanatorio Parque ( Site 1900) — Rosario, Santa Fe Province, Argentina (enrolling)
• FALP ( Site 0200) — Santiago, Region M. de Santiago, Chile (enrolling)
• Pontificia Universidad Catolica de Chile ( Site 0202) — Santiago, Region M. de Santiago, Chile (enrolling)
• Bradfordhill ( Site 0201) — Santiago, Region M. de Santiago, Chile (enrolling)
• Beijing Cancer Hospital ( Site 1604) — Beijing, Beijing Municipality, China (enrolling)
• Southern Medical University Nanfang Hospital ( Site 1608) — Guangzhou, Guangdong, China (enrolling)
• Jiangmen Central Hospital ( Site 1611) — Jiangmen, Guangdong, China (enrolling)
• The First Affiliated Hospital of Nanchang University ( Site 1610) — Nanchang, Jiangxi, China (enrolling)
• Shanghai East Hospital ( Site 1600) — Shanghai, Shanghai Municipality, China (enrolling)
• Sichuan Cancer hospital. ( Site 1609) — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.