A Randomized, Double-Blind, Phase 3 Study of MK-7684A Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Sep 27, 2027
  • participants needed
    700
  • sponsor
    Merck Sharp & Dohme LLC
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Updated on 25 October 2022
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Summary

The primary hypotheses are that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

Details
Condition Metastatic Non-Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Paclitaxel, Pembrolizumab, Pemetrexed, Nab-paclitaxel, Pembrolizumab/Vibostolimab
Clinical Study IdentifierNCT05226598
SponsorMerck Sharp & Dohme LLC
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
Has not received prior systemic treatment for metastatic NSCLC
Has measurable disease based on RECIST 1.1, as determined by the local site assessment
Has a life expectancy of at least 3 months
Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method

Exclusion Criteria

Known additional malignancy that is progressing or has required active treatment within the past 3 years
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Severe hypersensitivity to vibostolimab, pembrolizumab, chemotherapy components, and/or any of its excipients
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus
Received prior systemic anticancer therapy for metastatic disease
Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
History of allogenic tissue/solid organ transplant
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
Is unable or unwilling to take folic acid or vitamin B12 supplementation
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
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