Clinical trial NCT07008287: Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
Official title: A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ROS1-positive non-small cell lung cancer (NSCLC) with brain metastasis

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.


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.

Primary outcomes:
measure: ORR
timeFrame: 6 months
measure: iORR
timeFrame: 6 months
Secondary outcomes:
measure: PFS
timeFrame: 25 months
measure: DoR
timeFrame: 25 months
measure: DCR
timeFrame: 6 months
measure: OS
timeFrame: 51 months
measure: iPFS
timeFrame: 25 months
measure: iDoR
timeFrame: 6 months
measure: iDCR
timeFrame: 6 months
measure: Adverse events
timeFrame: 25 months
Other outcomes:
Locations:
Study officials:
References: