Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032

Neal Ready, Anna F. Farago, Filippo de Braud, Akin Atmaca, Matthew D. Hellmann, Jeffrey G. Schneider, David R. Spigel, Victor Moreno, Ian Chau, Christine L. Hann, Joseph Paul Eder, Nicola L. Steele, Anne Pieters, Justin Fairchild, Scott J. Antonia

Research output: Contribution to journalArticlepeer-review


Introduction: For patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open-label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies. We report results of third- or later-line nivolumab monotherapy treatment in SCLC. Methods: In this analysis, patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety. Results: Between December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy. At a median follow-up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5–19.5) with a median duration of response of 17.9 months (range 3.0–42.1). At 6 months, 17.2% of patients were progression-free. The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment-related adverse events. Conclusions: Nivolumab monotherapy provided durable responses and was well tolerated as a third- or later-line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third- or later-line treatment for this patient population.

Original languageEnglish
Pages (from-to)237-244
Number of pages8
JournalJournal of Thoracic Oncology
Issue number2
Publication statusPublished - Feb 2019


  • Immunotherapy
  • Nivolumab
  • PD-1 inhibitor
  • SCLC
  • Third-line

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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