Status:
NOT_YET_RECRUITING
Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Non-small Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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) following Entrectinib...
Eligibility Criteria
Inclusion
- 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.
- Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
- Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07199010
Start Date
October 1 2025
End Date
December 1 2027
Last Update
September 30 2025
Active Locations (1)
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1
Shanghai East Hospital (The East Hospital Affiliated to Tongji University)
Shanghai, Shanghai Municipality, China, 200120