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cemiplimab (n=356) vs. Standard of Care (SoC) (n=354)
randomized controlled trial
cemiplimab
cemiplimab 350 mg administered intravenously over aperiod of 30 min every 3 weeks (for up to 108 weeks[ie, up to 36 treatment cycles]) Cemiplimab dose modification was not allowed
ICC
four to six cycles ofinvestigator’s choice of platinum-doublet chemotherapy (n=128 paclitaxel plus carboplatin102 pemetrexed plus carboplatin39 pemetrexed plus cisplatin37 gemcitabine plus carboplatin37 gemcitabine plus cisplatin11 paclitaxel plus cisplatin) 74% crossed over to cemiplimab
Crossover from chemotherapy tocemiplimab was allowed following disease progression
mNSCLC - L1 - all population
Patients were ineligible if they had never smoked
open label
138 clinics in 24 countries
P3/ two sided and 5 interim analysis. To control type 1 error, two sided alpha 0.05 split between the analyses of overall survival (0·04)and progression-free survival (0·01). The α allocated to progression-free survival was subject to reallocation to overall survival, provided the progression-free survival analysis was positive, and vice versa.The key secondary endpoint of objective response rate was tested hierarchically when both analyses of overall survival and progression-free survival were significant
Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%,providing a potential new treatment option for this patient population.
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.
sintillimab plus SoC (n=266) vs. placebo plus SoC (n=131)
randomized controlled trial
Sintilimab plus pemetrexed plus platine
Sintilimab 200 mg was intravenously (IV) administered on day 1 of each cycle, once every 3 weeks (Q3W)
placebo plus pemetrexed plus platine
placebo was intravenously (IV) administered on day 1 of each cycle, once every 3 weeks (Q3W)
Patients in the placebo-combination group were eligible to cross over to receive sintilimab
mNSCLC - L1 - all population
including patient ineligible for radical surgery or radiotherapy, who had no sensitive EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements
double blind
47 hospitals in the People’s Republic of China.
P3/ one sided and one interim analysis. Only PFS tested stopped at AI1
AI 1 stopped : In Chinese patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC, the addition of sintilimab to chemotherapy with pemetrexed and platinum resulted in considerably longer PFS than with chemotherapy alone
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