Completely Resected NSCLC With Common EGFR Mutations Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 225 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Oncology, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-free survival | Time from the randomization to recurrence or any cause of death. | 5 years | |
Secondary | Overall survival | Time from the randomization to death of any cause | 5 year | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE4.0 | 5 years |