click on circles to display study description...
atezolizumab plus SoC (n=201) vs. placebo plus SoC (n=202)
randomized controlled trial
atezolizumab (as induction and maintenance therapy) plus carboplatin and etoposide
atezolizumab (at a dose of 1200 mg, administered intravenously on day 1 of each cycle) and(induction phase, four 21-day cycles of carboplatin (area under the curve of 5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle))
placebo plus carboplatin and etoposide
carboplatin and etoposide (induction phase, four 21-day cycles of carboplatin (area under the curve of 5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle))
Extensive stage SCLC (Es-SCLC) - 1st Line (L1)
no information about EGFR or ALK status
double-blind
106 sites in 21 countries
P3/ two sided and one interim analysis. Alpha split between coprimary endpoint and reallocation possible
The addition of atezolizumab to chemotherapy in the first-line treatment of extensive- stage small-cell lung cancer resulted in significantly longer overall survival and progression-free survival than chemotherapy alone.
durvalumab plus etoposide and platin (n=268) vs. etoposide plus platin (n=269)
randomized controlled trial
durvalumab, etoposide plus either cisplatin or carboplatin
durvalumab 1500 mg with or without tremelimumab 75 mg every 3 weeks followed by maintenance durvalumab 1500 mg every 4 weeks, associated with
etoposide plus either cisplatin or carboplatin
up to six cycles of platinum-etoposide every 3 weeks plus prophylactic cranial irradiation (investigator's discretion) Platinum-etoposide consisted of etoposide 80-100 mg/m2 on days 1-3 of each cycle with investigator's choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle)
all patients received etoposide plus either cisplatin or carboplatinIn /3 arms : durvalumab, with or without tremelimumab. Crossover from the platinum–etoposide to the immunotherapy plus platinum–etoposide groups was not allowed.
Extensive stage SCLC (Es-SCLC) - 1st Line (L1)
no specific information about EGFR or ALK status at inclusion
open-label
209 sites in 23 countries across Europe, Asia, North America, and South America
P3/ two sided and one interim analysi. Hierarchical multiple testing procedure with an α-exhaustive recycling strategy (OS/D : 4% and OS/DT 1% (recycle OS D)) then hierarchical testing with PFS/D and then PDS/DT
Durvalumab without tremelimumab plus platinum–etoposide significantly improved overall survival in patients with ES-SCLC versus a clinically relevant control group.
pembrolizumab plus SoC (n=228) vs. placebo plus SoC (n=225)
randomized controlled trial
pembrolizumab plus etoposide plus platine
pembrolizumab (200 mg fixed dose on Day 1 of each 21-day cycle) in combination with etoposide (100 mg/m2 on Days 1, 2 and 3) and investigator's choice of platinum chemotherapy (carboplatin titrated to AUC 5 on Day 1 or cisplatin 75 mg/m2 on Day 1)
placebo plus etoposide plus platine
Placebo in combination with etoposide (100 mg/m2 on Days 1, 2 and 3) and investigator's choice of platinum chemotherapy (carboplatin titrated to AUC 5 mg/mL/min on Day 1 or cisplatin 75 mg/m2 on Day 1).
Extensive stage SCLC (Es-SCLC) - 1st Line (L1)
double-blind
133 sites in 18 countries
P3/ one sided and two interim analysis. the study had 96% power to demonstrate a PFS HR of 0.65 at a = .006 with 387 PFS events at thefinal PFS analysis and 94%power to demonstrate an OS HRof 0.65 at a = .019 with 294 deaths at the final OS analysis. Then ORR can be tested with 0.001a reallocated from each PE.
Pembro plus etoposide/platine significantly improved PFS compared with placebo plus etoposide/platine as first-line therapy for patients with ES-SCLC but OS did not meet its significance treshold.
powered by vis.js Network