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)

Launched by MERCK SHARP & DOHME LLC · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment options for people with extensive-stage small cell lung cancer (SCLC) that has either come back after treatment or did not respond to previous therapies. The study focuses on two experimental drugs: Gocatamig, which helps the body’s immune system attack cancer cells, and Ifinatamab deruxtecan (I-DXd), which targets cancer cells and delivers medication directly to them. Researchers want to find out if these treatments are safe and if they can help shrink or eliminate tumors in patients whose cancer has not improved with other treatments.

To be eligible for this trial, participants must have been diagnosed with extensive-stage SCLC and must have already tried at least one previous treatment that included chemotherapy. They also need to provide a tissue sample for testing. There are some important health criteria that could exclude someone from participating, such as having certain heart or lung issues, active infections, or other serious medical conditions. If you join this trial, you’ll be closely monitored by healthcare professionals to assess how well the treatments work and how they affect your health.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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