Completely Resected NSCLC With Common EGFR Mutations
Conditions
Keywords
NSCLC, EGFR, adjuvant, gefitinib, intercalating
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.
Interventions
DRUGgefitinib, pemetrexed,cisplatin
* 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
Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 5 years | Time from the randomization to recurrence or any cause of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
South Korea
Contacts
Primary ContactByoung Chul Cho, MD
Outcome results
None listed