Status:
UNKNOWN
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.
Lead Sponsor:
Yonsei University
Conditions:
Completely Resected NSCLC With Common EGFR Mutations
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 mutation...
Eligibility Criteria
Inclusion
- 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
- Tumors with common EGFR mutations (19del or L858R)
- Adequate oran function
Exclusion
- Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
- Patients with interstitial lung disease
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT03381066
Start Date
April 10 2018
End Date
December 1 2022
Last Update
January 11 2019
Active Locations (1)
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1
Department of Oncology, Yonsei University College of Medicine
Seoul, South Korea, 03722