drugset / Trial / NCT03544814
EGFR-TKI Combined With Concurrent or Sequential Chemotherapy for Patients of Gradual Progression
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Icotinib | Small molecule | 125 mg | — |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | — |