Alliance Foundation Trial 09: A Randomized, Multicenter, Phase 2 Trial Evaluating Two Sequences of Pembrolizumab and Standard Platinum-Based Chemotherapy in Patients With Metastatic NSCLC

Thomas A. Hensing*, Xiaofei Wang, Thomas E. Stinchcombe, Junheng Gao, Michael V. Knopp, Mark Watson, Arkadiusz Z. Dudek, Stephen L. Graziano, Jyoti D. Patel, Bryan A. Faller, Konstantin H. Dragnev, David Kozono, Everett E. Vokes

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: The sequence of chemotherapy and pembrolizumab may affect antitumor immune response and efficacy of immunotherapy. Methods: This multicenter, randomized, phase 2 trial was designed to evaluate the efficacy of two sequences of chemotherapy and pembrolizumab in patients with stage 4 NSCLC. Both arms were considered investigational, and the study used a “pick a winner” design. The primary end point was objective response rate by independent radiologic review after eight cycles (24 wk). Patients were randomized 1:1 to arm A (chemotherapy for four cycles followed by pembrolizumab for four cycles) or arm B (pembrolizumab for four cycles followed by chemotherapy for four cycles). Patients in both arms without disease progression after the initial eight cycles continued pembrolizumab until disease progression, unacceptable toxicity, or a maximum of 2 years. Results: From March 2016 to July 2018, a total of 90 eligible patients were randomized (43 patients to arm A and 47 patients to arm B). The objective response rate at 24 weeks in arms A and B was 39.5 % (95 % confidence interval [CI]: 24.9%–54.1 %) and 40.4 % (95 % CI: 26.4%–54.5 %), respectively (p = 0.93). The progression-free survival in arms A and B was as follows: hazard ratio of B versus A equals to 1.06, 95 % CI: 0.68–1.66, p value equals to 0.84, and median progression-free survival of 5.8 months and 4 months, respectively. The overall survival was as follows: hazard ratio of B versus A equals to 1.04, 95 % CI: 0.63–1.74, p value equals to 0.85, and median overall survival of 15.5 months and 14 months, respectively. Conclusions: Additional evaluation of either sequence in a phase 3 trial is not warranted.

Original languageEnglish (US)
Article number100208
JournalJTO Clinical and Research Reports
Volume2
Issue number8
DOIs
StatePublished - Aug 2021

Keywords

  • Clinical trial
  • Immunotherapy
  • Immunotherapy and chemotherapy sequencing
  • Metastatic non–small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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