drugset / Trial / NCT01719536

Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

NCT01719536 ↗

Phase 3 Completed 296 enrolled Betta Pharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Timeline

Start
2012-12
Primary completion
2016-09
Completion
2017-02-07

Outcome

Met primary endpoint

paper Independent response evaluation committee-assessed PFS was significantly longer in the icotinib group (11.2 versus 7.9 months; hazard ratio, 0.61, 95% confidence interval 0.43-0.87; P = 0.006). PMID 28945850 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified — —
Subject Icotinib Small molecule 125 mg Oral
Comparator Pemetrexed Small molecule — —