Status:

RECRUITING

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Collaborating Sponsors:

Daiichi Sankyo

Conditions:

Small Cell Lung Cancer Extensive Stage

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 par...

Detailed Description

In Part A, participants will be allocated to Arm 1 or Arm 2 per investigator's discretion. In Part B, participants will be allocated to Arm 1 per investigator's discretion and randomized to Arms 2, 3,...

Eligibility Criteria

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

Key Trial Info

Start Date :

January 29 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2030

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT07227597

Start Date

January 29 2026

End Date

December 30 2030

Last Update

April 13 2026

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Orlando Health Cancer Institute ( Site 0108)

Orlando, Florida, United States, 32806

2

Saint Elizabeth Medical Center Edgewood ( Site 0112)

Edgewood, Kentucky, United States, 41017

3

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

Hackensack, New Jersey, United States, 07601

4

The University of Tennessee Medical Center ( Site 0120)

Knoxville, Tennessee, United States, 37920