Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with a histological diagnosis of non-small cell lung cancer. (2) Patients who meet any of the following criteria (i) through (iv): (i) Unresectable Stage III or Stage IV, ineligible for curative radiotherapy. (ii) Postoperative recurrence. (iii) Recurrence after curative thoracic radiotherapy, occurring 168 days or more after the final day of irradiation. (iv) Postoperative pathological Stage II-III without recurrence. (3) Patients who meet the following criteria 1) and 2) for driver genes. 1) For the ALK fusion gene, meets one of the following (However, for patients with postoperative pathological Stage II-III, only those who meet (a) are eligible): (a) Tested negative by a multi-gene panel test (e.g., Oncomine, Amoy, Lung Cancer Compact Panel, etc.) performed between June 1, 2019, and March 31, 2025, and confirmed positive by ALK-IHC (e.g., iAEP, D5F3, etc.). (b) Confirmed positive by a multi-gene panel test performed between June 1, 2019, and March 31, 2025. 2) Negative or unknown status for the following: EGFR mutations, ROS1 fusion gene, BRAF V600E mutation, MET exon 14 skipping alterations, RET fusion gene, and NTRK fusion gene.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, TTF, Positivity rate of the ALK fusion gene in other modalities, Patient background that are negative by multiplex testing but positive by IHC (in comparison with cases positive by multiplex testing). | — |
Countries
Japan
Contacts
Public ContactTaichi Matsubara
Kyushu University Hospital Thoracic Surgery
Outcome results
None listed