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nivolumab plus SoC (n=179) vs. placebo plus SoC (n=179)
randomized controlled trial
nivolumab plus platinum doublet
nivolumab 360 mg plus histology-based platinum doublet chemotherapy every three weeks for up to three doses
placebo plus platinum doublet
placebo plus platinum doublet chemotherapy every three weeks for up to three doses, followed by surgery
locally advanced NSCLC - (neo)adjuvant (NA)
open label
P3
nivolumab plus SoC (n=177) vs. pemetrexed plus platin (n=186)
randomized controlled trial
nivolumab plus pemetrexed plus platine
nivolumab (3 mg per kilogram of body weight every 2 weeks)
platinum based chemotherapy (pemetrexed plus platine)
platinum doublet chemotherapy based on tumor histologic type every 3 weeks for up to four cycles : pemetrexed (500 mg per square meter of body-surface area) plus cisplatin (75 mg per square meter) or carboplatin (area under the concentration-time curve [AUC], 5 or 6), every3 weeks for up to four cycles.Crossover between treatment groups within the trial was not permitted.
3 arms: Nivolumab, or Nivolumab Plus Ipilimumab.Crossover between treatment groups within the trial was not permitted.
mNSCLC - L1 - PDL1 negative
Patients with known EGFR mutations or ALK translocations sensitive to targeted therapy, an autoimmune disease, or untreated central nervous system metastases were excluded.Tumor mutational burden was determined by the FoundationOne CDx assay,
open label
NA
P3/ two sided and one interim analysis. Repartition between coprimary end point and hierarchy with secondary endpoint
Progression-free survival was significantly longer with first-line nivolumab plus ipilimumab than with chemotherapy among patients with NSCLC and a high tumor mutational burden, irrespective of PD-L1 expression level.
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.
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=338) vs. docetaxel (n=166)
randomized controlled trial
nivolumab
nivolumab 3 mg/kg every 2 weeks
docetaxel
docetaxel 75 mg/m2 every 3 weeks
mNSCLC - L2 - all population
patients with EGFR-mutation–positive tumors or knownALK receptor tyrosine kinase (ALK) translocation–positive tumors were excluded.
open label
32 hospitals and cancer/medical centers in China, Russia, and Singapore
P3/ two sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
In this predominantly Chinese population with previously treated advanced NSCLC, nivolumab improved OS (ORR and PFS as secondary endpoints) versus docetaxel.
nivolumab alone (n=292) vs. docetaxel (n=290)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks, Reductions in the nivolumab dose were not permitted.
docetaxel
docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks
non squamous - mNSCLC - L2 - all population
Patients with known EGFR mutation or ALK translocation were allowed to have received or be receiving an additional line of tyrosine kinase inhibitor therapy,
open-label
NA
P3/ two sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
IA results (stopped)/this trial meet its primary endpoint of OS and secondary endpoint ORR but not PFS
nivolumab alone (n=135) vs. docetaxel (n=137)
randomized controlled trial
Nivolumab
nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, Reductions in the nivolumab dose were not permitted.
Docetaxel
docetaxel, at a dose of 75 mg per square meter of body-surface area every 3 weeks
squamous - mNSCLC - L2 - all population
no information about EGFR or ALT status
open label
NA
P3/ two sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
IA results (stopped) / this trial meet its primary endpoint of OS and secondary endpoint ORR and PFS
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