Recruiting
Phase 1
Phase 2

Gocatamig & I-DXd

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07227597

Conditions

Small Cell Lung Cancer Extensive Stage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gocatamig

I-DXd

Atezolizumab

Carboplatin

Etoposide

Study Details

Brief 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

Conditions

Small Cell Lung Cancer Extensive Stage

Study ID

NCT07227597

Start date

Jan 29, 2026

Status verified date

Aug, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Nov 29, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1, Parts A and B: Gocataming + I-DXd

Participants who completed standard of care (SOC) induction chemotherapy with concurrent approved anti-programmed cell death 1/ligand 1 protein (anti-PD-1/L1) treatment for ES-SCLC and did not have disease progression per investigator discretion, will receive gocatamig and I-DXd in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.

experimental: Arm 2, Parts A and B: Gocataming + I-DXd

Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd during induction and maintenance phases, until documented disease progression or meeting other study discontinuation criteria.

experimental: Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab

Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd in the induction phase, followed by gocatamig and atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.

active comparator: Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumab

Participants who did not receive prior systemic treatment for ES-SCLC will receive SOC (carboplatin + etoposide + atezolizumab) in the induction phase, followed by atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.

Interventions

Gocatamig

Intravenous (IV) administration

I-DXd

IV administration

Atezolizumab

IV administration

Carboplatin

IV administration

Etoposide

IV administration

Rescue 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.

Primary outcome measure

  • Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 58 months ]
  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 21 days ]
  • Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 58 months ]
  • Objective Response Rate (ORR) [ Time Frame: Up to approximately 58 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Providence Medical Foundation ( Site 0124)

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Study Coordinator

707-521-3830

University of Colorado, Anschutz Cancer Pavilion ( Site 0125)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

303-724-4304

Orlando Health Cancer Institute ( Site 0108)

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

321-841-1869

Saint Elizabeth Medical Center Edgewood ( Site 0112)

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Study Coordinator

859-301-4000

Washington University School of Medicine ( Site 0134)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-747-1171

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5955

Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)

Recruiting

Portland, Oregon, United States, 97213

Contacts

Study Coordinator

503-215-5696

Avera Cancer Institute- Research ( Site 0104)

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

605-322-6900

The University of Tennessee Medical Center ( Site 0120)

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Study Coordinator

865-305-8780

Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Study Coordinator

901-351-3673

SCRI Oncology Partners ( Site 7000)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

844-482-4812

Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

646-407-2086

University of Virginia Health System ( Site 0122)

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Study Coordinator

434-924-4251

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-21.