Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Taletrectinib

• Registration Number: NCT07008287
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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) 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cohort 1	Taletrectinib	ROS1 fusion positive NSCLC patients with brain metastases who received taletrecitnib

Primary Outcome Measures

Name	Time	Method
ORR	6 months	Objective response rate
iORR	6 months	Intracranial objective response rate

Secondary Outcome Measures

Name	Time	Method
PFS	25 months	Progression free survival
DoR	25 months	Duration of response
DCR	6 months	Disease control rate
OS	51 months	Overall survival
iPFS	25 months	Intracranial progress free survival
iDoR	6 months	Intracranial duration of response
iDCR	6 months	Intracranial disease control rate
Adverse events	25 months	Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE 5.0