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Closed (no longer recruiting)Last updated: 28 November 2023

This phase III study is comparing the effectiveness of two types of immunotherapy treatments (MK-7684A and atezolizumab) when used in combination with chemotherapy (etoposide and carboplatin or cisplatin) in people with Extensive-Stage Small Cell Lung CancerA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200mg pembrolizumab and 200mg vibostolimab (also known as MK7684A) every 3 weeks, in combination with 100mg/m^2 etoposide, and platinum chemotherapy (Area Under the Curve [AUC] 5 mg/mL/min carboplatin or 75mg/m^2 cisplatin)every 3 weeks for a total of approximately 12 weeks. This will then be followed by additional cycles of MK7684A every 3 weeks. In the Active Comparator Arm, participants will receive 4 cycles (each cycle is 3 weeks) of 1200mg atezolizumab every 3 weeks, in combination with 100mg/m^2 etoposide and platinum chemotherapy (AUC 5mg/mL/min carboplatin or 75mg/m^2 cisplatin) every 3 weeks for a total of approximately 12 weeks. This will then be followed by additional cycles of atezolizumab every 3 weeks.

Conditions

This trial is treating patients with Extensive-Stage Small Cell Lung Cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Merck

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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