Seven (2%) deaths in the experimental group (acute kidney failure, diarrhoea, hepatotoxicity, hepatitis, pneumonitis, sepsis with acute renal insufficiency, and thrombocytopenia one patient each) and six (2%) deaths in the control group (anaemia, febrile neutropenia, pancytopenia, pulmonary sepsis, respiratory failure, and sepsis one patient each) were treatment related. Serious treatment-related adverse events of any grade occurred in 106 (30%) patients in the experimental group and 62 (18%) in the control group. The most common grade 3-4 treatment-related adverse events were neutropenia (in 24 patients in the experimental group vs 32 in the control group), anaemia (21 vs 50 ), diarrhoea (14 vs two ), increased lipase (22 vs three ), and asthenia (tjree vs eight ). With 3♵ months longer median follow-up (median 13♲ months ), median overall survival was 15♶ months (95% CI 13♹-20♰) in the experimental group versus 10♹ months (9♵-12♶) in the control group (HR 0♶6 ). At the pre-planned interim analysis (median follow-up 9♷ months ), overall survival in all randomly assigned patients was significantly longer in the experimental group than in the control group (median 14♱ months vs 10♷ months hazard ratio 0♶9 p=0♰0065).
Checkmate 9la brain metastases plus#
This study is active but no longer recruiting patients, and is registered with, number NCT03215706.īetween Aug 24, 2017, and Jan 30, 2019, 1150 patients were enrolled and 719 (62♵%) randomly assigned to nivolumab plus ipilimumab with two cycles of chemotherapy (n=361 ) or four cycles of chemotherapy alone (n=358 ). Results reported here are from a pre-planned interim analysis (when the study met its primary endpoint) and an exploratory longer-term follow-up analysis. Safety was analysed in all treated patients. The primary endpoint was overall survival in all randomly assigned patients. Randomisation was stratified by tumour histology, sex, and PD-L1 expression. Patients were randomly assigned (1:1) by an interactive web response system via permuted blocks (block size of four) to nivolumab (360 mg intravenously every 3 weeks) plus ipilimumab (1 mg/kg intravenously every 6 weeks) combined with histology-based, platinum doublet chemotherapy (intravenously every 3 weeks for two cycles experimental group), or chemotherapy alone (every 3 weeks for four cycles control group). Eligible patients were aged 18 years or older with treatment-naive, histologically confirmed stage IV or recurrent NSCLC, and an Eastern Cooperative Oncology Group performance status of 0-1.
Checkmate 9la brain metastases trial#
This randomised, open-label, phase 3 trial was done at 103 hospitals in 19 countries. We aimed to investigate whether the addition of a limited course (two cycles) of chemotherapy to this combination would further enhance the clinical benefit.
21 Austin Hospital, Heidelberg, VIC, Australia.20 Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.19 Pulmonary and Thoracic Oncology, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France.18 Léon Bérard Cancer Center, Lyon, France.17 Instituto Alexander Fleming, Buenos Aires, Argentina.16 Barretos Cancer Hospital, Barretos, Brazil.15 Hôpital Lyon Sud, Lyon, Pierre Bénite, France.14 Fundacion Arturo Lopez Perez, Santiago, Metropolitana, Chile.13 Instituto Medico Rio Cuarto SA, Córdoba, Argentina.12 Saitama Cancer Center, Saitama, Japan.
11 Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha, Bucharest, Romania.10 Hospital Universitario La Fe, Valencia, Spain.9 Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.8 Thoracic Oncology Unit, University Hospital of Nantes and INSERM, CRCINA, Nantes, France.7 Instituto Oncológico De Córdoba, Córdoba, Argentina.6 Hospital Nossa Senhora Da Conceição, Porto Alegre, Brazil.
Electronic address: 2 Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania.
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