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

NCT07227597 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 6070-003MK-6070-003U1111-1318-50252025-521032-11-00
• Study Type: interventional
• Target: 170
• Locations: 4 countries
• Sites: 15

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

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Experience an Adverse Event (AE)

  An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  Up to approximately 58 months

• Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)

  DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 21 days) that meets the protocol-specified DLT criteria. The number of participants who experience at least one DLT will be presented.

  Up to approximately 21 days

• Number of Participants Who Discontinue Study Intervention Due to an AE

  An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

  Up to approximately 58 months

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

  Up to approximately 58 months

Secondary Outcomes (22)

• Disease Control Rate (DCR)

  Up to approximately 58 months

• Duration of Response (DOR)

  Up to approximately 58 months

• Progression-Free Survival (PFS)

  Up to approximately 58 months

• Overall Survival (OS)

  Up to approximately 58 months

• Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig

  At designated time points (up to approximately 58 months)

Study Arms (4)

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

EXPERIMENTAL

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.

Drug: Gocatamig; Drug: I-DXd; Drug: Rescue Medications

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

EXPERIMENTAL

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.

Drug: Gocatamig; Drug: I-DXd; Drug: Rescue Medications

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

EXPERIMENTAL

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.

Drug: Gocatamig; Drug: I-DXd; Drug: Atezolizumab; Drug: Rescue Medications

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

ACTIVE COMPARATOR

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.

Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

Interventions

Etoposide DRUG

IV administration

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

Rescue Medications DRUG

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.

Arm 1, Parts A and B: Gocataming + I-DXd; Arm 2, Parts A and B: Gocataming + I-DXd; Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab

Gocatamig DRUG

Intravenous (IV) administration

Also known as: MK-6070, HPN328, DS-3280

Arm 1, Parts A and B: Gocataming + I-DXd; Arm 2, Parts A and B: Gocataming + I-DXd; Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab

I-DXd DRUG

IV administration

Also known as: MK-2400, DS-7300a

Arm 1, Parts A and B: Gocataming + I-DXd; Arm 2, Parts A and B: Gocataming + I-DXd; Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab

Atezolizumab DRUG

IV administration

Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab; Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumab

Carboplatin DRUG

IV administration

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (15)

Orlando Health Cancer Institute ( Site 0108)

Orlando, Florida, 32806, United States

RECRUITING

Saint Elizabeth Medical Center Edgewood ( Site 0112)

Edgewood, Kentucky, 41017, United States

RECRUITING

Washington University School of Medicine ( Site 0134)

St Louis, Missouri, 63110, United States

RECRUITING

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

Hackensack, New Jersey, 07601, United States

RECRUITING

Avera Cancer Institute- Research ( Site 0104)

Sioux Falls, South Dakota, 57105, United States

RECRUITING

The University of Tennessee Medical Center ( Site 0120)

Knoxville, Tennessee, 37920, United States

RECRUITING

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, 37203, United States

RECRUITING

Beijing Cancer Hospital ( Site 1604)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Shanghai East Hospital ( Site 1600)

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Taizhou Hospital of Zhejiang Province ( Site 1601)

Taizhou, Zhejiang, 317000, China

RECRUITING

Rambam Health Care Campus ( Site 0602)

Haifa, 3109601, Israel

RECRUITING

Sheba Medical Center ( Site 0601)

Ramat Gan, 5265601, Israel

RECRUITING

Seoul National University Hospital ( Site 1402)

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center ( Site 1404)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 1401)

Seoul, 06351, South Korea

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Interventions

atezolizumab; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 12, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): November 29, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7); KR (3); IL (2); CN (3)