Lung cancer is the most common cancer in the world and the leading cause of cancer-related deaths in Western countries. Unfortunately, at the time of diagnosis, the majority of patients already have metastatic disease and a systemic, palliative treatment is the primary therapeutic option. Guidelines for PS 2 patients or older than 75 years old patients at the time of diagnosis recommend for fit patients a carboplatin doublet chemotherapy. Nivolumab has proven efficacy in 3rd line squamous cell lung carcinoma and is superior to chemotherapy in 2nd line treatment of squamous and non-squamous lung cancer in term of overall survival. In 1st line, nivolumab failed to show superiority compared to a platin based doublet in terms of progression free survival and overall survival in tumors ≥ 5% PD-L1 expression. The association Nivolumab plus Ipilimumab showed encouraging results in first line setting in phase 1 study. The investigators think that with regard to the manageable toxicity of nivolumab in lung cancer population and the possibility to obtain long responses, this association could be a valid option for this population of elderly and/or PS2 patients in term of overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
217
Nivolumab dosed intravenously over 30 minutes at 240 mg every 2 weeks combined with Ipilimumab dosed intravenously over 30 minutes at 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol.
Doublet of chemotherapy according to standard of care carboplatin (AUC 5) with a dose that will be capped to 700 mg and pemetrexed (500 mg/m²) over 4 to 6 hours every three weeks (restricted to non-squamous histology) or carboplatin (AUC 6) with a dose that will be capped to 700 mg and paclitaxel (90 mg/m²) D1 D8 D15 over 4 to 6 hours every 4 weeks, with a maximum of 4 cycles of carboplatin based doublet, and the possibility to use maintenance with pemetrexed.
CH du Pays d'Aix
Aix-en-Provence, France
CHU d'Angers
Angers, France
CH de Beauvais
Beauvais, France
CHU de Brest
Brest, France
Centre Francois Baclesse
Caen, France
CH René Dubos
Cergy-Pontoise, France
CH de Charleville-Mézières
Charleville-Mézières, France
HIA Percy
Clamart, France
CH Intercommunal
Créteil, France
CH Intercommunal des Alpes du Sud
Gap, France
...and 20 more locations
Overall survival
Time frame: From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 3 years maximum
Survival rate
Time frame: 1 year
Objective response rate
according to RECIST 1.1
Time frame: 2 years
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum
Safety rate
Incidence of Treatment-Emergent Adverse Events according to CTCAE version 4.0
Time frame: 2 years
Tolerability rate
Incidence of Treatment-Emergent Adverse Events according to CTCAE version 4.0
Time frame: 2 years
Quality of life score
according to EQ-5D questionnaire
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum
Quality of life score
according to EORTC QLQ-ELD14 questionnaire
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum
PD-L1
testing by immunochemistry
Time frame: 2 years
Geriatric evaluation
according to geriatric mini data set
Time frame: inclusion and 2 months
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