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durvalumab alone (n=476) vs. placebo (n=237)
randomized controlled trial
Durvalumab as consolidation therapy
Durvalumab as consolidation therapy (at a dose of 10 mg per kilogram of body weight intravenously) every 2 weeks for up to 12 months, administered 1 to 42 days after the patients had received chemoradiotherapy
placebo
placebo every 2 weeks for up to 12 months
treatment received after chemoradiotherapy every 2 weeks as consolidation therapy for up to 12 months.
laNSCLC - M - all population
no specific information about EGFR or ALK status at inclusion
double-blind
NA
The overall 5% Type I error was equally split between the co-primary endpoints and the 2.5%v alpha can be recycled between PFS and OS, then hierarchical testing procedure with OS 24mo and ORR
Durvalumab therapy resulted in significantly longer OS and PFS than placebo
durvalumab alone (n=374) vs. Standard of Care (SoC) (n=372)
randomized controlled trial
durvalumab
durvalumab (20 mg/kg every 4 weeks)
platinum-based doublet chemotherapy
4 to 6 cycles of platinum-based doublet chemotherapy of the investigator’s choice : pemetrexed plus carboplatin (138 of 253 patients [54.5%]) and gemcitabine plus carboplatin (49 of 99 patients [49.5%])
3 arms: durvalumab with or without tremelimumab vs platinum-based doublet chemotherapy
mNSCLC - L1 - all population
only patient with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type were included
open-label
203 cancer treatment centers in 17 countries
P3/ two sided and two interim analysis. A hierarchical multiple testing procedure with a gatekeeping strategy was used to control family-wise type I error at a twosided 5% significance level.
The phase 3 MYSTIC study did not meet its primary end points of improved OS with durvalumab vs chemotherapy or improved OS or PFS with durvalumab plus tremelimumab vs chemotherapy in patients with ≥25% of tumor cells expressing PD-L1.
durvalumab alone (n=163) vs. Standard of Care (SoC) (n=162)
randomized controlled trial
durvalumab
durvalumab (20 mg/kg every 4 weeks)
platinum-based doublet chemotherapy
4 to 6 cycles of platinum-based doublet chemotherapy of the investigator’s choice : pemetrexed plus carboplatin and gemcitabine plus carboplatin (no % for this sub-population)
3 arms: durvalumab with or without tremelimumab vs platinum-based doublet chemotherapy
mNSCLC - L1 - PDL1 positive
only patient with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type were included
open-label
203 cancer treatment centers in 17 countries
P3/ two sided and two interim analysis. A hierarchical multiple testing procedure with a gatekeeping strategy was used to control family-wise type I error at a twosided 5% significance level.
The phase 3 MYSTIC study did not meet its primary end points of improved OS with durvalumab vs chemotherapy or improved OS or PFS with durvalumab plus tremelimumab vs chemotherapy in patients with ≥25% of tumor cells expressing PD-L1.
durvalumab alone (n=62) vs. Standard of Care (SoC) (n=64)
randomized controlled trial
durvalumab
durvalumab (10 mg/kg intravenously (i.v.) q2w for up to 12 months)
standard of care : erlotinib, gemcitabine or vinorelbine
1 of 3 SoC regimens: erlotinib (150 mg once a day by oral administration); gemcitabine (1000 mg/m2 i.v. over 30 minutes onDays 1, 8, and 15 of a 28-day cycle); or vinorelbine (30mg/m2 i.v. on Days 1, 8, 15, and 22 of a 28-day cycle). Gemcitabine: 34.4% vinorelbine: 32.8% and erlotinib:31.3%.
Dose reductions are not permitted for durvalumab or tremelimuab (mono and combi)
mNSCLC - L2 - PDL1 positive
patients with >25% of tumor cells (TCs) expressing programmed cell death ligand-1 (PD-L1). Patients who do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements
open label
205 study centers in 26 countries
P3/two sided and no interim anaysis. Repartition between primary endpoint (0.04 OS and 0.01 PFS) for study B only
this study did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS). the results of this study (A) were exploratory
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