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Clinical Trials in China / NCT07008287
Recruiting Observational

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

NCT07008287 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Observational
Started
2025-06-04
Last updated
2025-07-22

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Taletrectinib

Taletrectinib: Taletrectinib, 600mg, QD

Study summary

This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) with brain metastases. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

More Innovent Biologics (Suzhou) Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07008287 on ClinicalTrials.gov ↗ ← All trials in China