Randomized phase III study of nivolumab and ipilimumab versus carboplatin-based doublet in first-line treatment of PS 2 or elderly (≥ 70 years) patients with advanced non–small cell lung cancer (Energy-GFPC 06-2015 study)
Abstract
9011 Background: Combination of anti-PD1 and CTLA4 have showed superiority to chemotherapy (CT) in advanced non–small cell lung cancer (NSCLC), but data for fit elderly or PS2 patients are scarce. Methods: eNErgy compared the combination of nivolumab ipilimumab (N-I) to a platinum doublet in elderly or PS2 patients with advanced NSCLC. Primary endpoint was overall survival (OS), secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Main inclusion criteria were: stage IV histologically proven NSCLC, age ≥ 70 y, and PS 0/1/2 or age < 70 and PS2, EGFR ALK/ROS1 negative, judged fit enough to receive a platinum doublet. The main exclusion criteria were active cerebral metastasis or contraindication to N-I. Patients were randomly selected 1/1, stratified by age (≥ 70 vs. < 70 y), PS (0/1 vs. 2), and histology (squamous vs. no-squamous). Nivolumab (240 mg, 2w), ipilimumab, 1 mg/kg, 6w, was administrated until progression or unacceptable toxicity. CT was planned for 4 cycles, with carboplatin (AUC5) and pemetrexed (500 mg/m2, 3w) or paclitaxel (90 mg/m2, d1,d8, d15); 242 patients had to be randomized to detect a treatment effect hazard ratio (HR) on OS of 0.65, with a 85% power at a 2-sided alpha level of 5%. Results: A preplanned interim analysis carried out after observation of 33% of deaths, out of 174 randomized patients, showed a risk of futility especially for PS 2 patients, HR: 1.8 (95% CI, 0.99-3.3). This led to a halt in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 242 participants or records.
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