drugset / Trial / NCT02795884

Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation

NCT02795884

Phase 3 Withdrawn Yonsei University
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

EvaluationDrugModalityDoseRoute
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