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,cisplatinDrug: 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
Inclusion Criteria
- 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
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Exclusion Criteria
- Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
- Patients with interstitial lung disease
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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