Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study (WJOG17123L)
- Conditions
- Completely resected pathological stage IA2-IIA EGFR-mutated NSCLC
- Registration Number
- JPRN-UMIN000053514
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 800
Not provided
1) Patients with active double cancers *1 2) Patients with a localized or systemically active infection requiring treatment 3) Pregnant women, lactating women, and women who may be currently pregnant 4) Patients with clinically problematic psychiatric disorders that would preclude enrollment in the study 5) Patients receiving continuous systemic administration of steroids or immunosuppressive agents 6) Patients with history of serious hypersensitivity 7) Exclusions for complications (i) History of ILD, drug-induced ILD, radiation pneumonitis requiring steroid therapy, or active ILD. (ii) Viral hepatitis HBs antigen positive or HCV antibody positive (iii) HIV-positive (but negative confirmation by serologic testing is not required). 8) Other cases deemed inappropriate by the physician in charge *1 Double cancers are defined as synchronous duplications and heterochronic duplications with a disease-free interval of 5 years or less. Carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active double cancers.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method Overall survival, proportion of treatment completion, type of recurrence, type of treatment after recurrence, adverse events