click on circles to display study description...
atezolizumab plus carboplatin plus nab-paclitaxel (n=343) vs. carboplatin plus nab-paclitaxel (n=340)
randomized controlled trial
atezolizumab plus carboplatine plus nab-paclitaxel(ACnP)
Atezolizumab was administered at 1200 mg intravenously plus carboplatin at an area under the concentration-time curve of 6 mg/mL/min IV (day 1), nab-paclitaxel at 100 mg/m2 IV (days 1, 8, and 15).
carboplatine plus nab-paclitaxel (CnP)
carboplatin at an area under the concentration-time curve of 6 mg/mL/min IV (day 1), nab-paclitaxel at 100 mg/m2 IV (days 1, 8, and 15).
Crossover to atezolizumab was not allowed
squamous - mNSCLC - L1 - all population
Patients known to have EGFR mutations or ALK fusion oncogene were eligible
open label
317 study sites across 26 countries
P3/ two sided and two interim analysis. Alpha split between coprimary endpoint (ACnP) and hierarchy with OS/PFS (ACP)
Adding atezolizumab to platinum-based chemotherapy significantly improved PFS in patients with first-line squamous NSCLC; OS was similar between arms.
atezolizumab plus carboplatin plus paclitaxel (n=338) vs. nab-paclitaxel (n=340)
randomized controlled trial
atezolizumab plus carboplatine plus paclitaxel (ACP)
Atezolizumab was administered at 1200 mg intravenously and paclitaxel at 200 mg/m2 IV (175 mg/m2 for Asian race/ethnicity; day 1)
carboplatine plus nabpaclitaxel (CnP)
carboplatin at an area under the concentration-time curve of 6 mg/mL/min IV (day 1), nab-paclitaxel at 100 or 200 mg/m2 IV (days 1, 8, and 15)
Crossover to atezolizumab was not allowed
squamous - mNSCLC - L1 - all population
Patients known to have EGFR mutations or ALK fusion oncogene were eligible
open label
317 study sites across 26 countries
P3/ two sided and two interim analysis. Alpha split between coprimary endpoint (ACnP) and hierarchy with OS/PFS (ACP)
Adding atezolizumab to platinum-based chemotherapy significantly improved PFS in patients with first-line squamous NSCLC; OS was similar between the arms.No efficay results for this arm because of hierarchy
ipilimumab plus SoC (n=479) vs. placebo plus SoC (n=477)
randomized controlled trial
ipilimumab plus paclitaxel and carboplatin
ipilimumab 10 mg/kg or placebo IV given every 12 weeks
placebo plus paclitaxel and carboplatin
ipilimumab matched placebo IV given every 12 weeks and paclitaxel 175 mg/m2 plus carboplatinarea under the concentration-time curve 6, both given intravenously (IV) every 3 weeks for six 3-week cycles
treatment given as induction and maintenance. No subject crossover between treatment arms is allowed in this study.
squamous - mNSCLC - L1 - all population
double blind
233 sites in 34 countries
P3 / two-sided test procedure with no formal interim analysis. Hierachical testing procedure with secondary endpoint : OS (ITT) then PFS. Study with randomization at the beginning of the induction period is inappropriate to evaluate only maintenance treatment interest.
The addition of ipilimumab to first-line chemotherapy did not prolong OS compared with chemotherapy alone in patients with advanced squamous NSCLC.
pembrolizumab plus SoC (n=278) vs. placebo plus SoC (n=281)
randomized controlled trial
pembrolizumab plus platine and (nab)paclitaxel
200 mg of pembrolizumab on day 1 for up to 35 cycles in 3-week cycles and for the first 4 cycles, carboplatin (at a dose calculated to produce an area under the concentration–time curve of 6 mg per milliliter per minute)on day 1 and either paclitaxel (200 mg per square meter of body-surface area) on day 1 or nab-paclitaxel (100 mg per square meter) on days 1, 8, and 15
placebo plus platine and (nab)paclitaxel
placebo on day 1 for up to 35 cycles in 3-week cycles and for the first 4 cycles, carboplatin (at a dose calculated to produce an area under the concentration–time curve of 6 mg per milliliter per minute)on day 1 and either paclitaxel (200 mg per square meter of body-surface area) on day 1 or nab-paclitaxel (100 mg per square meter) on days 1, 8, and 15
patients with progression will have the opportunity to crossover to receive open-label pembrolizumab monotherapy
squamous - mNSCLC - L1 - all population
no information about EGFR or ALK status
open-label
137 sites in 17 countries
P3/ one sided and three interim analysis. Repartition and reallocation between coprimary endpoint PFS OS and then ORR
AI2 (stopped) In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab-paclitaxelresulted in significantly longer overall survival and progression-free survival than chemotherapyalone
powered by vis.js Network