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nivolumab alone (n=211) vs. Standard of Care (SoC) (n=212)
randomized controlled trial
Nivolumab
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression
platinum-based chemotherapy
investigator’s choice of platinum doublet chemotherapy (every 3 weeks for four to six cycles) Squamous: gemcitabine 1250 mg/m2 plus cisplatin 75 mg/m2 (11.1%); gemcitabine 1000 mg/m2 plus carboplatin AUC 5 (12.5%); paclitaxel 200 mg/m2 plus carboplatin AUC 6(6.1%); nonsquamous: pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 (32.7%); pemetrexed 500 mg/m2 plus carboplatin AUC 6(43.7%) (% for ITT pop)
Patients who progressed on chemotherapy could crossover to nivolumab as second line treatment.
mNSCLC - L1 - PDL1 positive
Patients with EGFR activating mutations and ALK translocations, which are sensitive to targeted therapy, were excluded. Determination of PD-L1 status using the analytically validated IHC assay.
open label
NA
P3/ two sided no interim analysis planned. no specific testing procedure for secondary endpoints
nivolumab monotherapy did not result in longer progression-free survival than platinum-based chemotherapy as first-line treatment for stage IV or recurrent NSCLC in a broad population of patients with a PD-L1 expression level of 5% or more.
nivolumab alone (n=271) vs. Standard of Care (SoC) (n=270)
randomized controlled trial
Nivolumab
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression
platinium doublet chemotherapy
investigator’s choice of platinum doublet chemotherapy (every 3 weeks for four to six cycles) Squamous: gemcitabine 1250 mg/m2 plus cisplatin 75 mg/m2 (11.1%); gemcitabine 1000 mg/m2 plus carboplatin AUC 5 (12.5%); paclitaxel 200 mg/m2 plus carboplatin AUC 6(6.1%); nonsquamous: pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 (32.7%); pemetrexed 500 mg/m2 plus carboplatin AUC 6(43.7%)
Patients who progressed on chemotherapy could crossover to nivolumab as second line treatment. Maintenance therapy with pemetrexed was allowed in patients with nonsquamous NSCLC
mNSCLC - L1 - PDL1 positive
Patients with EGFR activating mutations and ALK translocations, which are sensitive to targeted therapy, were excluded.
open label
NA
P3/ two sided no interim analysis planned. no specific testing procedure for secondary endpoints
nivolumab monotherapy did not result in longer progression-free survival than platinum-based chemotherapy as first-line treatment for stage IV or recurrent NSCLC in a broad population of patients with a PD-L1 expression level of 5% or more.
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