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)

Description

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Researchers want to know if giving gocatamig and/or I-DXd can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig and I-DXd are safe and well tolerated * If people who receive gocatamig and I-DXd have their SCLC get smaller or go away

Conditions

Small Cell Lung Cancer

Study Overview

Study Details

Study overview

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Researchers want to know if giving gocatamig and/or I-DXd can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig and I-DXd are safe and well tolerated * If people who receive gocatamig and I-DXd have their SCLC get smaller or go away

A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

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)

Condition
Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103), Hackensack, New Jersey, United States, 07601

Nashville

Sarah Cannon Research Institute ( Site 7001), Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 tissue sample or fresh biopsy tissue sample
  • * Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • * Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
  • * History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
  • * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • * History of clinically significant intracranial bleeding or spinal cord bleeding
  • * Active neurologic paraneoplastic syndrome
  • * 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
  • * Has other uncontrolled or significant protocol-specified cardiovascular disease
  • * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
  • * Chronic liver disease, including liver cirrhosis of Child-Pugh class B or C
  • * 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
  • * Ongoing treatment with immunosuppressive medications, with protocol-specified exceptions
  • * 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: Other anticancer therapy, including cytotoxic agents, targeted agents, immunotherapies, antibody, retinoid, transplant, or anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[LHRH\]) within 2 weeks before start of study intervention
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2028-10-31