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KEYNOTE-671: A phase III, randomized, double-blind trial of platinum doublet chemotherapy +/- pembrolizumab (MK-3475) as neoadjuvant/adjuvant therapy for participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC)

Description

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy before surgery (neoadjuvant phase), followed by pembrolizumab alone after surgery (adjuvant phase) in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).

Status

Accepting new patients

Primary Study Objective(s)

The primary study objectives are:

  • Event-free survival, defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause
  • Overall survival, defined as the time from randomization until death from any cause

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have previously untreated, histologically confirmed NSCLC and histologically confirmed Stage IIB or IIIA NSCLC
  • Are able to undergo protocol therapy, including necessary surgery
  • If male, agree to use contraception or practice abstinence as well as refrain from donating sperm for at least 180 days after the last dose of study treatment
  • If female, are not pregnant, not breastfeeding, and at least one of the following conditions apply:
    • Not a woman of childbearing potential (WOCBP)
    • WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment
  • Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission (If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 [PD-L1] testing)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization
  • Have adequate organ function

Excluding patients who:

  • Have one of the following tumor locations/types:
    • NSCLC involving the superior sulcus
    • Large cell neuro-endocrine cancer (LCNEC)
    • Sarcomatoid tumor
  • Have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or have current pneumonitis/interstitial lung disease that requires steroids
  • Have an active infection requiring systemic therapy
  • Have had an allogenic tissue/sold organ transplant
  • Have a known severe hypersensitivity (≥ grade III) to pembrolizumab, its active substance and/or any of its excipients
  • Have a known severe hypersensitivity (≥ grade III) to any of the study chemotherapy agents and/or to any of their excipients
  • Have an active autoimmune disease that has required systemic treatment in past two years
  • Have a known history of human immunodeficiency virus (HIV) infection
  • Have a known history of hepatitis B or hepatitis C
  • Have a known history of active tuberculosis
  • Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate
  • Have known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial
  • Have received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor
  • Have received prior systemic anti-cancer therapy, including investigational agents for the current malignancy prior to randomization/allocation
  • Have received prior radiotherapy within two weeks of start of trial treatment
  • Have received a live vaccine within 30 days prior to the first dose of trial drug
  • Are currently participating in or have participated in a trial of an investigational agent or have used an investigational device within four weeks prior to the first dose of trial treatment
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Patricia Rich

Ashish Sangal

Shayma Master Kazmi