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 University225 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

225

Conditions

Completely Resected NSCLC With Common EGFR Mutations

Interventions

gefitinib, pemetrexed,cisplatinDRUG

* Intercalation phase (Duration: 3weeks x 4 cycles = 12 weeks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, every 3week * Maintenance phase (Duration: 1 year) Gefitinib 250mg D1-2

Vinorelbine, cisplatinDRUG

Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Oncology, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

disease-free survival

Time from the randomization to recurrence or any cause of death.

Time frame: 5 years

Secondary Outcomes

Overall survival

Time from the randomization to death of any cause

Time frame: 5 year

Number of participants with treatment-related adverse events as assessed by CTCAE4.0

Time frame: 5 years

Central Contacts

Byoung Chul Cho, MD

CONTACT

82 2 2228 0880 cbc1971@yuhs.ac

Data from ClinicalTrials.gov

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