Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061120) titled 'A Multicenter Prospective Observational Study of Taletrectinib in Patients with Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer (ROSETTA study)(WJOG22925L)' on April 1.

Study Type: Observational

Primary Sponsor: Institute - West Japan Oncology Group

Condition: Condition - Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To evaluate the efficacy and safety of Taletrectinib in ROS1 fusion positive advanced or recurrent non small cell lung cancer (NSCLC)through real-world clinical data collection and biomarker measurements. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with advanced or recurrent ROS1 fusion positive non small cell lung cancer (NSCLC) that is not amenable to curative treatment. 2. Patients meet one of the following prior treatment criteria: Cohort A: patients who have not previously received treatment with a ROS1 TKI; or Cohort B: patients who have previously received treatment with one or more ROS1 TKI. *There are no restrictions regarding prior treatment with cytotoxic chemotherapy, immune checkpoint inhibitors, or other therapies. 3. Patients who have not previously received taletrectinib and are scheduled to initiate taletrectinib in routine clinical practice in accordance with the latest Japanese package insert. (In principle, treatment with taletrectinib should be initiated after written informed consent has been obtained and patient registration in the electronic data capture (EDC) system has been completed. However, initiation of treatment before EDC registration will be permitted, provided that EDC registration is completed by the next business day after informed consent is obtained.) 4. Patients have undergone radiologic evaluation with CT, including the chest, within 42 days prior to the date of registration, and brain MRI or CT within 56 days prior to the date of registration.Contrast enhanced CT and MRI are preferred; however, non contrast imaging will also be permitted. 5. Patients are aged 18 years or older. 6. Patients have provided written informed consent prior to study registration after receiving a full explanation of the study. Key exclusion criteria - Patients who are deemed unsuitable for participation in this clinical study by the investigator or treating physician. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2032 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069875

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