SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study)

摘要: Abstract Introduction The objective of the Lung-MAP sub-study S1400A was to evaluate response rate durvalumab, an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with squamous non–small-cell lung cancer (SqNSCLC). Patients and Methods who progressed on at least prior platinum-based chemotherapy were eligible. study designed as a phase II/III trial comparing durvalumab docetaxel but modified single-arm, II primary endpoint when immunotherapy became approved treatment. Results A total 116 registered this sub-study; 78 38 docetaxel. Of patients, 9 ineligible, not evaluable for endpoints. Responses achieved 11 among 68 eligible (overall rate, 16%; 95% confidence interval [CI], 7%-25%). disease control 54% (95% CI, 43%-66%), median overall survival 11.6 months 10.2-14.3 months), progression-free 2.9 2.0-4.0 months). PD-L1 data available 43 14 (33%) PD-L1–positive (≥ 25%) 2 responses 14%; 0%-33%), 57% 31%-83%), 10.7 9.2-14.3 months) 2.3 1.4-4.2 respectively. Grade ≥ 3 treatment-related adverse events occurred 22 (32%) 6 discontinuing owing drug-related (9%; 2%-16%). Conclusions Durvalumab shows single-agent activity toxicities sub-group that is comparable other cell death protein 1/PD-L1 antibodies.