non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically confirmed non-small cell lung cancer. 2) Patients who are confirmed to be EGFR mutation-positive based on a tumor tissue sample or cytological sample (including uncommon mutation). However, an EGFR mutation test must have been performed before the date of confirmation of recurrence if the patient has started or completed postoperative adjuvant chemotherapy, or if the patient is being followed up without postoperative adjuvant chemotherapy and is enrolled after confirmation of recurrence. 3) Patients who have undergone anatomic lung resection (except wedge resection) with curative intent and were confirmed to be at pathological stage II to III (TNM classification [UICC 9th edition]). 4) R0, R0 (un), R1 (is), or R1 (cy+) has been pathologically confirmed based on a sample resected in surgery. 5) Patients who are >= 18 years at the time of informed consent. 6) ECOG performance status (PS) is 0 to 2 at the time of enrollment. 7) Patients who have had surgery within 56 weeks (392 days) (the same day of the week 56 weeks after the date of surgery is allowed for enrollment). Enrollment can be before or after the start of postoperative adjuvant chemotherapy. 8) Patients with no history of neoadjuvant therapy (chemotherapy, immunotherapy, molecular targeted therapy, radiotherapy, or combination of these) for the target non-small cell lung cancer. 9) Patients who have given written informed consent after receiving thorough explanation of the study details prior to this study enrollment.
Exclusion criteria
Exclusion criteria: 1) Pregnant women, lactating women, women who may be pregnant at the moment, or persons who have no intention of using birth control. 2) Patients with double cancer requiring treatment at the time of enrollment (however, carcinoma in situ and lesions equivalent to intramucosal carcinoma that are clinically or pathologically confirmed are not included in double cancer even if they are untreated.) 3) Patients with concurrent psychiatric disease or symptom that, in the opinion of the treating physician, would make it difficult for them to participate in the study. 4) Persons who are judged by the treating physician to be inappropriate for safe implementation of this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Countries
Japan
Contacts
Public ContactNaoki Ishizuka
West Japan Oncology Group WJOG datacenter
Outcome results
None listed