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A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) versus Platinum Based Chemotherapy in Treatment Naïve Subjects with PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)

Trial Profile

A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) versus Platinum Based Chemotherapy in Treatment Naïve Subjects with PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2019

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At a glance

  • Drugs Pembrolizumab (Primary) ; Carboplatin; Paclitaxel; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-042
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 02 Oct 2019 According to a Merck and Co media release, based on results from this trial, the National Medical Products Administration (NMPA) in China has approved KEYTRUDA as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), whose tumors express PD-L1 (tumor proportion score [TPS] =1%) as determined by a NMPA-approved test, with no EGFR or ALK genomic tumor aberrations.
    • 10 Sep 2019 Results of Taylor-Expansion Adjustment for Survival Analyses in Immunotherapy Trials, presented at the 20th World Conference on Lung Cancer.
    • 10 Sep 2019 Results of a pooled analysis from two studies (KEYNOTE-042 global and China extension; n=262) presented at the 20th World Conference on Lung Cancer.
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