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A Study of Gocatamig and Infinatamab Deruxtecan for Extensive-Stage Small Cell Lung Cancer

This study is looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that has spread. Researchers are investigating if giving Gocatamig (a T-cell engager therapy) and Infinatamab Deruxtecan (I-DXd, an antibody drug conjugate) together can help. They will also explore combining these study medicines with standard treatments like chemotherapy (Carboplatin, Etoposide) and immunotherapy (Atezolizumab). The study aims to understand the safety of these treatments by tracking side effects and how many participants need to stop treatment due to side effects. You may be eligible if you are 18 or older and have a confirmed diagnosis of ES-SCLC. The study plans to enroll about 170 people.

Study design
This is an interventional study with an unclear phase, planning to enroll 170 participants. Participants will be assigned to different treatment groups, some based on investigator's discretion and others through randomization.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety outcomes for up to approximately 58 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227597

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~170 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:GocatamigI-DXdAtezolizumabCarboplatinEtoposideRescue Medications

At a glance

Recruiting sites
52 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience an Adverse Event (AE)
Measured over Up to approximately 58 months
+3 more outcomes measured

Conditions

Small Cell Lung Cancer Extensive Stage

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

52 sites across 35 states
South Korea4
Tennessee3
Region M. de Santiago3
Attica3
Buenos Aires2
Guangdong2
Zhejiang2
Greece2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 58 months

    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.

  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)Up to approximately 21 days

    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.

  • Number of Participants Who Discontinue Study Intervention Due to an AEUp to approximately 58 months

    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.

  • Objective Response Rate (ORR)Up to approximately 58 months

    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.