Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases

Inclusion criteria

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

• Age ≥ 18 years.
• Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).
• At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.
• Radiographically confirmed brain metastasis(es) , with stable CNS symptoms within 2 weeks prior to enrollment.
• Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
• 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).
• Signed Informed Consent.

Exclusion criteria

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

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