NCT07008287Recruiting
Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 28 May 2025
- Start date
- 4 Jun 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07008287
What you commit to
- Study type: Observational
- Planned participants: 100
- From 4 Jun 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .
- Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.
Other illness
- Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.
Lab values
- Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.
Other
- Patient presenting with any of the following criteria will not be included in the study：
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.