Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression
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 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 in Advanced ROS1+ NSCLC Following Entrectinib Progression
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) following Entrectinib progression. 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]
Secondary outcome measures (9)
- PFS [Time frame: 25 months]
- DoR [Time frame: 25 months]
- DCR [Time frame: 6 months]
- OS [Time frame: 51 months]
- iORR [Time frame: 6 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
- 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.
- Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
- Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.
- 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
- 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
- Shanghai East Hospital (The East Hospital Affiliated to Tongji University) — Shanghai
Identifiers
NCT: NCT07199010 · IBI344-RWS-001