Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060363) titled 'Efficacy of ALK-TKIs for IHC-positive/Multiplex-negative ALK lung cancer' on Jan. 16.

Study Type: Observational

Primary Sponsor: Institute - Kyushu University

Condition: Condition - Non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - The objective of this study is to evaluate the efficacy of ALK inhibitors in ALK fusion-positive lung cancer that tested negative by multiplex testing but positive by IHC, and to examine the positivity rate of ALK fusions using other testing modalities. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key exclusion criteria - None Target Size - 140

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 10 Day Date of IRB - 2025 Year 12 Month 25 Day Anticipated trial start date - 2026 Year 01 Month 16 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067512

Disclaimer: Curated by HT Syndication.