Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line treatment for stage IV squamous non-small cell lung cancer: A phase 1b and randomized, open-label, multicenter, phase 2 trial in Japan

Satoshi Watanabe, Hiroshige Yoshioka, Hiroshi Sakai, Katsuyuki Hotta, Mitsuhiro Takenoyama, Kazuhiko Yamada, Shunichi Sugawara, Yuichi Takiguchi, Yukio Hosomi, Keisuke Tomii, Seiji Niho, Nobuyuki Yamamoto, Makoto Nishio, Yuichiro Ohe, Terufumi Kato, Toshiaki Takahashi, Ami Kamada, Kazumi Suzukawa, Yukie Omori, Sotaro EnatsuKazuhiko Nakagawa, Tomohide Tamura

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objectives: This open-label, multicenter, phase 1b/2 study assessed necitumumab plus gemcitabine and cisplatin (GC + N) in patients with previously untreated squamous non-small cell lung cancer in Japan. Materials and methods: The phase 1b part determined the gemcitabine dose for the phase 2 part, in which patients were randomized 1:1 to GC + N or gemcitabine and cisplatin (GC) (gemcitabine 1250 mg/m2 on days 1 and 8; cisplatin 75 mg/m2 on day 1 of maximum four 3-week cycles; nectimumab 800 mg on days 1 and 8 of a 3-week cycle continued until progressive disease or unacceptable toxicity). The primary endpoint of the phase 2 part was overall survival. Results: In the phase 2 part, 181 patients received GC + N (N = 90) or GC (N = 91). Overall survival was significantly improved with GC + N versus GC (median, 14.9 months vs 10.8 months; hazard ratio [HR] = 0.66, 95% CI: 0.47 – 0.93, p = 0.0161). Improvements were also observed in progression-free survival (median, 4.2 months vs 4.0 months; HR = 0.56; p = 0.0004) and objective response rate (51% vs 21%; p < 0.0001). Survival was also significantly prolonged with GC + N versus GC for patients with epidermal growth factor receptor-positive tumors. Grade ≥3 treatment-emergent adverse events at ≥5% higher incidence with GC + N than GC were neutrophil count decreased (42% vs 35%), febrile neutropenia (12% vs 3%), decreased appetite (11% vs 4%), and dermatitis acneiform (6% vs 0%). Conclusion: GC + N is well tolerated and has significant and clinically meaningful treatment benefit in the first-line treatment of patients with squamous non-small cell lung cancer in Japan. Clinicaltrials.gov identifier: NCT01763788.

Original languageEnglish
Pages (from-to)55-62
Number of pages8
JournalLung Cancer
Volume129
DOIs
Publication statusPublished - Mar 2019

Keywords

  • Cisplatin
  • Gemcitabine
  • Japan
  • Necitumumab
  • Non-small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Watanabe, S., Yoshioka, H., Sakai, H., Hotta, K., Takenoyama, M., Yamada, K., Sugawara, S., Takiguchi, Y., Hosomi, Y., Tomii, K., Niho, S., Yamamoto, N., Nishio, M., Ohe, Y., Kato, T., Takahashi, T., Kamada, A., Suzukawa, K., Omori, Y., ... Tamura, T. (2019). Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line treatment for stage IV squamous non-small cell lung cancer: A phase 1b and randomized, open-label, multicenter, phase 2 trial in Japan. Lung Cancer, 129, 55-62. https://doi.org/10.1016/j.lungcan.2019.01.005