Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lungcancer Patients Previsouly Treated EGFR-TKI
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
This is a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to
evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo combined with
chemotherapyin Advanced Non-small Cell Lung Cancer (NSCLC) Participants with TKI-resistant
EGFR-mutated Tumors; and evaluate the population with the best predictive biomarkers, i.e.,
positive diagnosis population.
About 350 subjects with advanced non-small cell lung cancer with activated EGFR mutation will
be 1:1 randomized into two groups, JS001 combined with the standard 1st-line chemotherapy
will be given in the study group whereas placebo combined with standard 1st-line chemotherapy
will be given in the control group. The stratification will be based on the following
factors:
The history of the previous lines of EGFR-TKI treament ( 1st or 2nd line of TKI vs. 3rd line
of TKI vs. 1st or 2nd line of TKI + 3rd line of TKI) ; Disease stage (IIIB-C vs. IV);