Taletrectinib for advanced ROS1-positive non-small cell lung cancer with brain metastases (real-world use)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, non-interventional observational study enrolls adults with stage IV ROS1-positive NSCLC and radiographically confirmed brain metastases who are prescribed taletrectinib by their treating physicians. Taletrectinib is given according to routine clinical practice and data on treatment patterns, tumor response (per RECIST v1.1), progression, survival, and adverse events are collected during standard visits. The study accepts prospective patients and retrospective patients with up to 6 months of prior taletrectinib exposure, with a consent waiver allowed for deceased retrospective patients when permitted. Collected real-world data will be analyzed to describe effectiveness and safety of taletrectinib in this specific population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for enrollment into the study:

1. Age ≥ 18 years.
2. Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).
3. At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.
4. Radiographically confirmed brain metastasis(es) , with stable CNS symptoms within 2 weeks prior to enrollment.
5. Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
6. Considered by the investigator to be candidates for Taletrectinib treatment ; OR Patients with ≤6 months of prior Taletrectinib exposure enrolled retrospectively. (Note: For retrospective patients deceased before enrollment, waiver of informed consent is required. Patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible).
7. Signed Informed Consent.

Exclusion Criteria:

Patient presenting with any of the following criteria will not be included in the study：

1. Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.
2. Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .
3. Pregnancy or breastfeeding.
4. Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.
5. Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.