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)

Published:November 10, 2020DOI:



      The objective of the Lung-MAP sub-study S1400A was to evaluate the response rate to durvalumab, an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with squamous non–small-cell lung cancer (SqNSCLC).

      Patients and Methods

      Patients who progressed on at least 1 prior platinum-based chemotherapy were eligible. The study was designed as a phase II/III trial comparing durvalumab with docetaxel but was modified to a single-arm, phase II trial with the primary endpoint of objective response when immunotherapy became an approved treatment.


      A total of 116 patients were registered to this sub-study; 78 to durvalumab and 38 to docetaxel. Of the 78 patients, 9 were ineligible, and 1 was not evaluable for endpoints. Responses were achieved in 11 patients among the 68 eligible and evaluable patients on durvalumab (overall response rate, 16%; 95% confidence interval [CI], 7%-25%). The disease control rate was 54% (95% CI, 43%-66%), the median overall survival was 11.6 months (95% CI, 10.2-14.3 months), and the median progression-free survival was 2.9 months (95% CI, 2.0-4.0 months). PD-L1 data was available for 43 patients on durvalumab, with 14 (33%) patients who were PD-L1–positive (≥ 25%) and 2 responses (overall response rate, 14%; 95% CI, 0%-33%), the disease control rate was 57% (95% CI, 31%-83%), the median overall survival and progression-free survival were 10.7 months (95% CI, 9.2-14.3 months) and 2.3 months (95% CI, 1.4-4.2 months), respectively. Grade ≥ 3 treatment-related adverse events occurred in 22 (32%) patients on durvalumab, with 6 discontinuing owing to drug-related adverse events (9%; 95% CI, 2%-16%).


      Durvalumab shows single-agent activity and toxicities in this sub-group of patients that is comparable with other anti-programmed cell death protein 1/PD-L1 antibodies.


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        • Borghaei H.
        • Paz-Ares L.
        • Horn L.
        • et al.
        Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer.
        N Engl J Med. 2015; 373: 1627-1639
        • Brahmer J.
        • Reckamp K.L.
        • Baas P.
        • et al.
        Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer.
        N Engl J Med. 2015; 373: 123-135
        • Herbst R.S.
        • Baas P.
        • Kim D.W.
        • et al.
        Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial.
        Lancet. 2016; 387: 1540-1550
        • Cancer Genome Atlas Research Network
        Comprehensive genomic characterization of squamous cell lung cancers.
        Nature. 2012; 489: 519-525
        • Siegel R.L.
        • Miller K.D.
        • Jemal A.
        Cancer statistics, 2017.
        CA Cancer J Clin. 2017; 67: 7-30
        • Stewart R.
        • Morrow M.
        • Hammond S.A.
        • et al.
        Identification and Characterization of MEDI4736, an antagonistic anti-PD-L1 monoclonal antibody.
        Cancer Immunol Res. 2015; 3: 1052-1062
        • Rizvi N.A.
        • Brahmer J.R.
        • Ou S.H.I.
        • et al.
        Safety and clinical activity of MEDI4736, an antiprogrammed cell death-ligand 1 (PD-L1) antibody, in patients with non-small cell lung cancer (NSCLC).
        J Clin Oncol. 2015; 33: 8032
        • Garassino M.C.
        • Cho B.C.
        • Kim J.H.
        • et al.
        • ATLANTIC Investigators
        Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study.
        Lancet Oncol. 2018; 19: 521-536
        • Rizvi N.A.
        • Hellmann M.D.
        • Snyder A.
        • et al.
        Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer.
        Science. 2015; 348: 124-128
        • Carbone D.P.
        • Reck M.
        • Paz-Ares L.
        • et al.
        • CheckMate 026 Investigators
        First-line nivolumab in stage IV or recurrent non-small-cell lung cancer.
        N Engl J Med. 2017; 376: 2415-2426
        • Antonia S.J.
        • Villegas A.
        • Daniel D.
        • et al.
        • PACIFIC Investigators
        Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC.
        N Engl J Med. 2018; 379: 2342-2350
        • Rittmeyer A.
        • Barlesi F.
        • Waterkamp D.
        • et al.
        • OAK Study Group
        Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial.
        Lancet. 2017; 389: 255-265