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durvalumab plus osimertinib (n=14) vs. osimertinib (n=15)
randomized controlled trial
durvalumab plus osimertinib
durvalumab (10 mg/kg administered intravenously every 2 weeks) plus osimertinib (80 mg once daily)
osimertinib
osimertinib (80 mg once daily)
mNSCLC - L2 - EGFR mutant
Disease progression after EGFR-TKI therapy was mandatory; other lines of therapy also may have been given.
open design
nine centers in South Korea, Canada, and the Republic of China
P3/ no alpha no interim analysis. All results are exploratory. CAURAL recruitment was terminated early because of increased incidence of interstitial lung disease–like events in the osimertinib plus durvalumab arm from the separate phase Ib TATTON trial (NCT02143466).
efficacy related objectives are considered exploratory
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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