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Phase 1Recruiting

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

Sponsored by Merck Sharp & Dohme LLC

About this study

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

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, and 4.

Where this study is enrolling (13)

  • Providence Medical Foundation ( Site 0124)

    Santa Rosa, California

    Call 707-521-3830

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  • University of Colorado, Anschutz Cancer Pavilion ( Site 0125)

    Aurora, Colorado

    Call 303-724-4304

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  • Orlando Health Cancer Institute ( Site 0108)

    Orlando, Florida

    Call 321-841-1869

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  • Saint Elizabeth Medical Center Edgewood ( Site 0112)

    Edgewood, Kentucky

    Call 859-301-4000

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  • Washington University School of Medicine ( Site 0134)

    St Louis, Missouri

    Call 314-747-1171

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Show all 13 locations

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

    Hackensack, New Jersey

    Call 551-996-5955

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

    Portland, Oregon

    Call 503-215-5696

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  • Avera Cancer Institute- Research ( Site 0104)

    Sioux Falls, South Dakota

    Call 605-322-6900

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  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee

    Call 844-482-4812

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  • The University of Tennessee Medical Center ( Site 0120)

    Knoxville, Tennessee

    Call 865-305-8780

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

    Memphis, Tennessee

    Call 901-351-3673

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

    Houston, Texas

    I'm interested

  • University of Virginia Health System ( Site 0122)

    Charlottesville, Virginia

    Call 434-924-4251

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.