Recruiting
Phase 1
Phase 2

Gocatamig & Ifinatamab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06780137

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gocatamig

Ifinatamab Deruxtecan (I-DXd)

Durvalumab

Study Details

Brief summary:

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

Conditions

Small Cell Lung Cancer

Study ID

NCT06780137

Start date

Feb 27, 2025

Status verified date

Aug, 2026

Completion date

Apr 27, 2029

Anticipated

Primary completion date

Apr 27, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

327 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Arm 1: Gocatamig and I-DXd

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

experimental: Part 1 Arm 2: Gocatamig and I-DXd

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

experimental: Part 1 Arm 3a: I-DXd Monotherapy

Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.

experimental: Part 1 Arm 3b: Gocatamig and I-DXd

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

experimental: Part 2 Arm 4: Gocatamig Monotherapy in Japan

Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.

experimental: Part 2 Arm 5: Gocatamig Monotherapy in China

Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.

experimental: Part 2 Arm 6: Gocatamig

Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.

experimental: Part 3 Arm 7: Gocatamig and Durvalumab

Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.

experimental: Part 2 Arm 8: Gocatamig (Alternate Presentation)

Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.

Interventions

Gocatamig

IV infusion

Ifinatamab Deruxtecan (I-DXd)

IV infusion

Durvalumab

IV infusion

Primary outcome measure

  • Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 44 months ]
  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 3 weeks ]
  • Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 44 months ]
  • Part 1: Objective Response Rate (ORR) [ Time Frame: Up to approximately 44 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

University of Colorado Anschutz Medical Campus ( Site 1110)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

303-724-6268

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)

Recruiting

Miami, Florida, United States, 33136

Contacts

Study Coordinator

305-243-1754

University of Chicago ( Site 1108)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Study Coordinator

773-702-6149

Dana Farber Cancer Institute ( Site 1105)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-632-6049

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5863

Roswell Park Cancer Institute ( Site 1107)

Recruiting

Buffalo, New York, United States, 14263

Contacts

Study Coordinator

716-845-3167

Providence Portland Medical Center ( Site 1101)

Recruiting

Portland, Oregon, United States, 97213

Contacts

Study Coordinator

503-215-5696

Sarah Cannon Research Institute ( Site 7001)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

844-482-4812

Medical College of Wisconsin ( Site 1112)

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Study Coordinator

414-805-8900

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.