Actively Recruiting
Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-07-22
100
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed metastatic non-small cell lung cancer (Stage IV)
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Brain metastasis confirmed by imaging with stable symptoms within 2 weeks before enrollment
- Documented ROS1 gene fusion identified by approved molecular tests (FISH, RT-PCR, or NGS)
- Deemed eligible for Taletrectinib treatment by investigator or retrospectively enrolled with up to 6 months prior Taletrectinib exposure
- Signed informed consent
You will not qualify if you...
- Presence of other driver gene mutations with approved targeted therapies (e.g., EGFR, ALK, RET)
- Participation in other interventional clinical trials or investigational drug use within 4 weeks before enrollment
- Pregnancy or breastfeeding
- Uncontrolled co-morbid conditions preventing targeted therapy as assessed by investigator
- Any other condition deemed unsuitable for study participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 201107
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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