Clinical Trial: Co-occurring genomic alterations and outcomes of ALK inhibitor therapy in ALK-positive non-small cell lung cancer (Japan)

Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063214) titled 'Co-occurring genomic alterations and outcomes of ALK inhibitor therapy in ALK-positive non-small cell lung cancer' on Oct. 8.

Study Type: Observational

Primary Sponsor: Institute - Saiseikai Matsusaka Municipal Hospital

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

Objective: Narrative objectives1 - To describe the distribution of pretreatment co-occurring genomic alterations in ALK-positive non-small cell lung cancer and to exploratorily evaluate the associations of TP53, RB1, and MTAP alterations with progression-free survival and overall survival after first-line ALK inhibitor therapy. An exploratory composite genomic group based on these alterations will also be evaluated, and supportive external analyses will be performed, primarily focusing on RB1, using available clinico-genomic datasets. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with pathologically or cytologically confirmed non-small cell lung cancer 2. Patients with confirmed ALK rearrangement 3. Patients treated at the study institution between March 2012 and May 2025 4. Patients with available genomic data obtained by comprehensive genomic profiling 5. Patients with available clinical information required to evaluate ALK inhibitor treatment and clinical outcomes Key exclusion criteria - 1. Patients with insufficient genomic information for evaluation of the association with treatment outcomes 2. Patients for whom the clinical course after ALK inhibitor therapy or survival information cannot be adequately evaluated 3. Patients considered inappropriate for analysis by the principal investigator Target Size - 30

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 08 Month 15 Day Date of IRB - 2026 Year 08 Month 21 Day Anticipated trial start date - 2026 Year 08 Month 21 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072325

Disclaimer: Curated by HT Syndication.