Completely resected pathological stage IA2-IIA EGFR-mutated NSCLC
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven non-squamous non-small cell lung cancer 2) Pathological stage IA2 and high risk, or stage IA3, IB, IIA (TNM 8th edition) Pathological high-risk cases are satisfying any of the following factors. - Lymphovascular invasion - High-grade histological type (micropapillary, solid, or complex gland adenocarcinoma >= 20%) 3) Total tumor diameter <= 5 cm 4) No preoperative treatment 5) Complete resection by lobectomy or segmentectomy. 6) MRI or CT scan of the brain must be done prior to surgery. Patients in whom this was not done prior to surgery may still be enrolled if MRI or CT scan is performed prior to registration . 7) EGFR gene mutations have been identified (two frequent EGFR mutations [Ex19del or L858R] expressed alone or simultaneously with other EGFR mutations [T790M, G719X, exon 20 insertion, S7681, L861Q, etc.]) 8) Postoperative adjuvant therapy with tegafur-uracil or Osimertinib, or observation without treatment is planned. 9) Age at consent: 18 years and older 10) ECOG performance status (PS) 0-1 11) Latest laboratory values within 56 days prior to enrollment meet all of the following. (postoperative, same day of the week 8 weeks prior to enrollment is acceptable) - Neutrophil count (absolute) >= 1,500 /mm3 - Platelet count >= 100,000 /mm3 - Hemoglobin >= 9.0 g/dL - ALT <= 105 U/L (male), <= 57.5 U/L (female) - AST <= 75 U/L - Total bilirubin <= 2.25 mg/dL or confirmed Gilbert's syndrome (unconjugated hyperbilirubinemia), total bilirubin <= 4.5 mg/dL - Creatinine <= 1.605 mg/dL (male), <= 1.185 mg/dL (female) or creatinine clearance >= 50 mL/min (measured value or value calculated by the Cockcroft-Gault formula should be used). Creatinine clearance will be evaluated only when creatinine exceeds 1.605 mg/dL (male) or 1.185 mg/dL (female). 12) Written consent is obtained.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, proportion of treatment completion, type of recurrence, type of treatment after recurrence, adverse events | — |
Countries
Japan
Contacts
Public ContactNaoki Ishizuka
West Japan Oncology Group WJOG datacenter
Outcome results
None listed