🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07199010
Starting soon Observational

Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression

NCT07199010 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Observational
Started
2025-10
Last updated
2025-09-30

Condition(s) studied

Non-small 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) following Entrectinib progression. 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: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai East Hospital (The East Hospital Affiliated to Tongji University) Shanghai Shanghai Municipality

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 NCT07199010 on ClinicalTrials.gov ↗ ← All trials in China