drugset / Trial / NCT02795884
Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will be performed as a local multicenter, randomized, phase III clinical study. It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy alone. The patients will be randomly assigned to the Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the ratio of 1:1. The treatment regimen of each arm is as follows.
Timeline
- Start
- 2016-06
- Primary completion
- 2020-11
- Completion
- 2020-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |