Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Taletrectinib.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
Overview
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.
Interventions
- Drug Taletrectinib
Taletrectinib, 600mg, QD
Primary outcome measures
- ORR [Time frame: 6 months]
- iORR [Time frame: 6 months]
Secondary outcome measures (8)
- PFS [Time frame: 25 months]
- DoR [Time frame: 25 months]
- DCR [Time frame: 6 months]
- OS [Time frame: 51 months]
- iPFS [Time frame: 25 months]
- iDoR [Time frame: 6 months]
- iDCR [Time frame: 6 months]
- Adverse events [Time frame: 25 months]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
Patient presenting with any of the following criteria will not be included in the study：
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07008287 · IBI344-RWS-002