Taletrectinib for advanced ROS1-positive non-small cell lung cancer with brain metastases (real-world use)

A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases

This will try taletrectinib in adults with ROS1-positive non-small cell lung cancer that has spread to the brain to see how well it works and whether it is safe in routine care.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: Taletrectinib
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07008287 on ClinicalTrials.gov

What this trial studies

This multicenter, non-interventional observational study enrolls adults with stage IV ROS1-positive NSCLC and radiographically confirmed brain metastases who are prescribed taletrectinib by their treating physicians. Taletrectinib is given according to routine clinical practice and data on treatment patterns, tumor response (per RECIST v1.1), progression, survival, and adverse events are collected during standard visits. The study accepts prospective patients and retrospective patients with up to 6 months of prior taletrectinib exposure, with a consent waiver allowed for deceased retrospective patients when permitted. Collected real-world data will be analyzed to describe effectiveness and safety of taletrectinib in this specific population.

Who should consider this trial

Good fit: Adults (≥18) with stage IV NSCLC and a documented ROS1 fusion, at least one measurable lesion, radiographically confirmed brain metastases with stable CNS symptoms, and who are judged by their physician to be candidates for taletrectinib (or who received ≤6 months of taletrectinib retrospectively) are ideal candidates.

Not a fit: Patients without a confirmed ROS1 fusion, without brain metastases, with unstable CNS symptoms, or who are not candidates for taletrectinib are unlikely to be eligible or to benefit from this study's findings.

Why it matters

Potential benefit: If successful, the results could show taletrectinib helps control brain metastases and is tolerable in routine practice, supporting its use for ROS1-positive NSCLC patients with CNS involvement.

How similar studies have performed: Other ROS1-targeted drugs have shown intracranial activity in clinical trials, but published real-world data specifically for taletrectinib in patients with brain metastases remain limited.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Conditions Non-Small Cell Lung Cancer