A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.

Yonsei University

Status and phase: Unknown; Phase 3

Conditions: Completely Resected NSCLC With Common EGFR Mutations

Treatments: Drug: gefitinib, pemetrexed,cisplatin; Drug: Vinorelbine, cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03381066

4-2016-0763

Details and patient eligibility

About

This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.

Enrollment: 225 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
2. Tumors with common EGFR mutations (19del or L858R)
3. Adequate oran function

Exclusion criteria

1. Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
2. Patients with interstitial lung disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

225 participants in 2 patient groups

Intercalating arm

Experimental group

Description:

gefitinib, pemetrexed,cisplatin

Treatment:

Drug: gefitinib, pemetrexed,cisplatin

chemotherapy alone arm

Active Comparator group

Description:

Vinorelbine, cisplatin

Treatment:

Drug: Vinorelbine, cisplatin