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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.
durvalumab plus tremelimumab plus SoC (n=268) vs. etoposide plus platin (n=269)
randomized controlled trial
durvalumab plus tremelimumab and 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,
etoposide plus either cisplatin or carboplatin
etoposide plus either cisplatin or carboplatin In up to six cycles of platinum-etoposide every 3 weeks (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) plus prophylactic cranial irradiation (investigator's discretion).
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 analysis. A 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
only durvalumab without tremelimumab plus platinum–etoposide significantly improved overall survival in patients with ES-SCLC versus a clinically relevant control group.
ipilimumab plus SoC (n=566) vs. placebo plus SoC (n=566)
randomized controlled trial
Ipilimumab plus etoposide plus platine
ipilimumab 10 mg/kg intravenously (IV) (3-week cycles and then 12 week cycles for maintenance) plus etoposide 100 mg/m2 IV on days 1, 2, and 3 of each cycle and investigator’s choice of platinum agent on day 1 of each cycle (cisplatin 75 mg/m2 IV or carboplatin area under the concentration-time curve 5 IV) during cycles one to four of induction
Placebo plus etoposide plus platine
placebo (3-week cycles), etoposide 100 mg/m2 IV on days 1, 2, and 3 of each cycle and investigator’s choice of platinum agent on day 1 of each cycle (cisplatin 75 mg/m2 IV or carboplatin area under the concentration-time curve 5 IV) during cycles one to four of induction
No dose reductions were permitted for ipilimumab or placebo
Extensive stage SCLC (Es-SCLC) - 1st Line (L1)
double-blind
224 study sites in 34 countries,
P3 / two-sided test procedure with no formal interim analysis. Secondary efficacy endpoints will be tested in the following hierarchical order: OS in the population of all randomized subjects followed by PFS per mWHO among randomized subjects who received at least one dose of blinded study therapy. study with randomization at the beginning of the induction period is inappropriate to evaluate only maintenance interest.
Addition of ipilimumab to chemotherapy did not prolong OS versus chemotherapy alone in patients with newly diagnosed extensive-stage disease SCLC.
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.
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