Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008)

• Status: Not yet recruiting
• Trial end date: 2027-06-07
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atezolizumab; Carboplatin; Etoposide; Pembrolizumab

Criteria

Inclusion Criteria:

• Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy

• Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan

• Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse

• Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse

• Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

• Has a predicted life expectancy of >3 months

Exclusion Criteria:

• Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease

• Has received prior treatment for Small Cell Lung Cancer (SCLC)

• Is expected to require any other form of antineoplastic therapy for SCLC while on study

• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication

• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients

• Has an active autoimmune disease that has required systemic treatment in past 2 years

• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

• Has a known history of, or active, neurologic paraneoplastic syndrome

• Has an active infection requiring systemic therapy

• Has a known history of human immunodeficiency virus (HIV) infection

• Has a known history of Hepatitis B or known active Hepatitis C virus infection

• Has had an allogenic tissue/solid organ transplant

• Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention

• Has symptomatic ascites or pleural effusion