Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression

Innovent Biologics

Status

Not yet enrolling

Conditions

Non-small Lung Cancer

Treatments

Drug: Taletrectinib

Study type

Observational

Funder types

Industry

Identifiers

NCT07199010

IBI344-RWS-001

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.