Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial

摘要: Summary Background Treatments for small-cell lung cancer (SCLC) after failure of platinum-based chemotherapy are limited. We assessed safety and activity nivolumab plus ipilimumab in patients with SCLC who progressed one or more previous regimens. Methods The cohort this phase 1/2 multicentre, multi-arm, open-label trial was conducted at 23 sites (academic centres hospitals) six countries. Eligible were 18 years age older, had limited-stage extensive-stage SCLC, disease progression least platinum-containing regimen. Patients received (3 mg/kg bodyweight intravenously) every 2 weeks (given until unacceptable toxicity), (1 1 mg/kg, 3 four cycles, followed by weeks. either assigned to monotherapy a dose-escalating the nivolumab/ipilimumab combination beginning mg/kg. Depending on tolerability, then primary endpoint objective response investigator assessment. All analyses included enrolled 90 days before database lock. This is ongoing; here, we report an interim analysis cohort. study registered ClinicalTrials.gov, number NCT01928394. Findings Between Nov 18, 2013, July 28, 2015, 216 treated (98 three 61 54 mg/kg). At lock 6, median follow-up continuing (including those died discontinued treatment) 198·5 (IQR 163·0–464·0) 302 not calculable) 361·0 (273·0–470·0) 260·5 (248·0–288·0) An achieved ten (10%) 98 receiving (33%) 14 (23%) (19%) Grade 4 treatment-related adverse events occurred 13 (13%) cohort, (30%) cohort; most commonly reported grade increased lipase (none vs 5 [8%] none) diarrhoea [5%] [2%]). No event. Six (6%) group, seven (11%) (7%) group treatment due events. Two from (myasthenia gravis worsening renal failure), patient pneumonitis. Interpretation Nivolumab showed antitumour durable responses manageable profiles previously SCLC. These data suggest potential new approach population limited options support evaluation randomised controlled trials Funding Bristol-Myers Squibb.