Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed non-small cell lung cancer. (In the osimertinib cohort, with proven EGFR gene mutations.) 2) Frozen specimens (about 5 mm square) of tumor tissue that can be analyzed for whole genome analysis are stored. 3) Pulmonary resection for curative intent has been performed and the diagnosis of pathological stage II-III (TNM classification (UICC 8th edition)) 4) 18 years or older. 5) Performance status (ECOG) of 0-2. 6) With a plan to receive osimertinib or PD-1/PD-L1 inhibitors as postoperative adjuvant treatment. [Osimertinib cohort] patients will receive or has already started the treatment with osimertinib. [ICI cohort] patients will receive or has already started the treatment with PD-1/PD-L1 inhibitors. 7) Written informed consent concerning study participation
Exclusion criteria
Exclusion criteria: 1) Localized or systemically active infection requiring treatment. 2) Pregnant women, lactating women, women who may be currently pregnant, or cases of unwillingness to use contraception. 3) Clinically problematic psychiatric disorders precluding enrollment. 4) Requirement of continuous systemic administration of steroid, and the current use of an immunosuppressant. 5) History of severe hypersensitivity 6) History of interstitial lung disease, drug-induced interstitial lung disease, idiopathic pulmonary fibrosis, radiation pneumonitis requiring steroid therapy, or active interstitial lung disease. 7) Others judged by the investigator to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed