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Study design: CheckMate 9LA (NSCLC with chemo)


  • Phase 3 randomized study in patients with recurrent/metastatic NSCLC1
  • Primary endpoint: OS1
  • Secondary endpoints: PFS by BICRa; ORR by BICRa; efficacy by tumor PD-L1 expression1

aHierarchically statistically tested. bDetermined by the PD-L1 IHC 28-8 pharmDx assay (Dako). cPatients unevaluable for PD-L1 were stratified to PD-L1 <1% and capped to 10% of all randomized patients. dNSQ: pemetrexed + cisplatin or carboplatin; SQ: paclitaxel + carboplatin. Figure adapted from Paz-Ares et al. 2021.1
ALK, anaplastic lymphoma kinase; BICR, blinded independent central review; chemo, chemotherapy; ECOG PS, Eastern Clinical Oncology Group Performance Status; EGFR, epidermal growth factor receptor; IHC, immunohistochemistry; IPI, ipilimumab; NIVO, nivolumab; NSCLC, non-small cell lung cancer; NSQ, non-squamous; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; QxW, every x weeks; R, randomization; SQ, squamous.

1. Paz-Ares L, et al. Lancet Oncol 2021;22:198–211.