A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Jun 7, 2027
  • participants needed
    450
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 24 October 2022
Investigator
Toll Free Number
Primary Contact
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709) (0.0 mi away) Contact
+93 other location
measurable disease
etoposide
carboplatin
pembrolizumab
cancer chemotherapy
atezolizumab

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.

Details
Condition Small Cell Lung Carcinoma
Treatment cisplatin, etoposide, carboplatin, Saline Placebo, Atezolizumab, Pembrolizumab/Vibostolimab Co-Formulation
Clinical Study IdentifierNCT05224141
SponsorMerck Sharp & Dohme LLC
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
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
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