Pemetrexed vs Pemetrexed Plus Cisplatin in EGFR-mutant NSCLC Patients After First Line EGFR-TKIs Failure
Status:
Recruiting
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
The study is a prospective, multi-center, open-label, randomized, and controlled phase II
clinical trial. The investigators hope to figure out the better chemotherapy regimen for the
post-EGFR-TKI failure setting. The primary objective of this trial is to compare
progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin and
single-agent pemetrexed treatment arms.
The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease
progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2
arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500
mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged
by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as
maintenance until progression or intolerable toxicities. Patients in arm B will receive
pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.