A randomized phase II study comparing nivolumab with carboplatin-pemetrexed for patients with EGFR mutation–positive nonsquamous non–small cell lung cancer who acquire resistance to tyrosine kinase inhibitors not due to a secondary T790M mutation: rationale and protocol design for the WJOG8515L study

Antibodies to programmed cell death–1 (PD-1) such as nivolumab have shown promising clinical activity in patients with advanced non–small cell lung cancer (NSCLC), but their efficacy appears to be less pronounced in patients with such tumors harboring epidermal growth factor receptor gene (EGFR) mutations. Recent findings suggest that patients with EGFR mutation–positive NSCLC who develop resistance to tyrosine kinase inhibitors (TKIs) due to mechanisms other than acquisition of the secondary T790M mutation of EGFR are more likely to benefit from nivolumab treatment, possibly as a result of a higher level of expression of the PD-1 ligand PD-L1, than are T790M-positive patients.

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