Clinical Trial

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)

MOA: Adagrasib is an oral, selective inhibitor of KRASG12C mutant

Key Eligibility:

• Histologically or cytologically confirmed diagnosis of Nsq NSCLC
• Measurable disease per RECIST v1.1
• Evidence of KRASG12Cmutation via tumor sample and/or ctDNA by
  approved testing
• Any PD-L1 expression (0-100%) as determined by Ventana or pharmDx IHC
• Tumor tissue (archival or fresh) should be submitted
• Prior systemic anti-cancer tx given for advanced NSCLC is not allowed
  • Prior systemic neoadjuvant, adjuvant, or peri-operative systemic tx is
    allowed if completed at least 6 months prior to first dose
• Pts with brain metastases are eligible if pts are asymptomatic and not in
  need of immediate local therapy
• Pts with leptomeningeal metastases or brainstem lesions are excluded
• Pts with documented additional targetable oncogenic driver mutation or
  alteration genes such as EGFR, ALK, BRAF V600E, HER2, MET exon 14,
  ROS1, RET, or NTRK1/2/3 for which there is a SoC treatment available are
  excluded
• Pts who received previous treatment targeting KRASG12C mutation in any
  setting are excluded