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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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