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Necitumumab plus gemcitabine and cisplatin vs 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 Jan 21, 2019

Watanabe S, et al. - In this open-label, multicenter, phase 1b/2 study, researchers assessed necitumumab plus gemcitabine and cisplatin (GC + N) in patients with previously untreated squamous non-small cell lung cancer in Japan. They randomized patients 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). GC + N led to significantly improved overall survival, improved progression-free survival and objective response rate when compared with GC. Patients with epidermal growth factor receptor-positive tumors also displayed significantly prolonged survival with GC + N vs GC. Outcomes thus suggest that these patients could tolerate GC + N with significant and clinically meaningful treatment benefit in the first-line treatment.

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