drugset / Trial / NCT03544814

EGFR-TKI Combined With Concurrent or Sequential Chemotherapy for Patients of Gradual Progression

NCT03544814

Phase 2 Completed 99 enrolled Shanghai Chest Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the efficacy of simultaneous EGFR-TKI and chemotherapy with that of sequential treatment after patients gradually progressed from first-line EGFR-TKI treatment. Patients who had gradual progression and EGFR-T790M mutation-negative were randomly divided into two groups: in concurrent group, patients were treated with pemetrexed plus cisplatin along with the same EGFR-TKI; in sequential group, patients continued with EGFR-TKI until the disease progressed again according to the RECIST criteria, and then switched to chemotherapy. We evaluated progression-free survival (PFS) and overall survival (OS) time of patients. For sequential group, PFS was PFS1 (gradual progression to discontinue EGFR-TKI) plus PFS2 (chemotherapy alone).

Timeline

Start
2015-01-01
Primary completion
2017-06-01
Completion
2017-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2
Subject Icotinib Small molecule 125 mg
Subject Pemetrexed Small molecule 500 mg/m2

Indications