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A Study of Gocatamig and Ifinatamab Deruxtecan for Small Cell Lung Cancer

This study is looking for new ways to treat extensive-stage small cell lung cancer (SCLC) that has come back or didn't respond to previous treatment. Researchers are testing two new treatments, Gocatamig and Ifinatamab Deruxtecan (I-DXd), and also Durvalumab, which is another type of immunotherapy. Gocatamig is an immunotherapy that helps your body's immune system fight cancer. I-DXd is a drug that targets and destroys cancer cells. Durvalumab is also an immunotherapy that helps destroy cancer cells. The study wants to see if these treatments, alone or in combination, are safe and effective. You may be able to join if you are 18 or older, have extensive-stage SCLC that has been treated before with platinum-based chemotherapy, and can provide a tumor tissue sample. The study is looking at how many participants experience side effects or need to stop treatment due to side effects.

Study design
This study is interventional and plans to enroll 327 participants. It has multiple parts to assess different drug combinations and safety in different regions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects and dose-limiting toxicities for up to approximately 44 months, with specific assessments for dose-limiting toxicities within approximately 3 weeks.

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

NCT06780137

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~327 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:GocatamigIfinatamab Deruxtecan (I-DXd)Durvalumab

At a glance

Recruiting sites
45 of 46 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 44 months
+3 more outcomes measured

Conditions

Small Cell Lung Cancer

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

46 sites across 32 states
Israel4
Spain4
Region M. de Santiago3
Shanghai Municipality2
South Korea2
Barcelona2
Taiwan2
Turkey (Türkiye)2

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 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

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

What this trial measures

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 44 months

    An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented.

  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)Up to approximately 3 weeks

    A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) 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 44 months

    An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented.

  • Part 1: Objective Response Rate (ORR)Up to approximately 44 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 the investigator will be presented.