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.

Phase 3

• Conditions: Completely Resected NSCLC With Common EGFR Mutations
• Interventions: Drug: gefitinib, pemetrexed,cisplatin; Drug: Vinorelbine, cisplatin

• Registration Number: NCT03381066
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Study Start: 2018-04-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intercalating arm	gefitinib, pemetrexed,cisplatin	gefitinib, pemetrexed,cisplatin
chemotherapy alone arm	Vinorelbine, cisplatin	Vinorelbine, cisplatin

Primary Outcome Measures

Name	Time	Method
disease-free survival	5 years	Time from the randomization to recurrence or any cause of death.

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 year	Time from the randomization to death of any cause
Number of participants with treatment-related adverse events as assessed by CTCAE4.0	5 years

Trial Locations

Locations (1)

Department of Oncology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of