Non-small Lung Cancer
Conditions
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) 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
DRUGTaletrectinib
Taletrectinib, 600mg, QD
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6 months | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 51 months | Overall survival |
| iORR | 6 months | Intracranial objective response rate |
| iPFS | 25 months | Intracranial progress free survival |
| iDoR | 6 months | Intracranial duration of response |
| DCR | 6 months | Disease control rate |
| DoR | 25 months | 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 |
| PFS | 25 months | Description: Progression free survival |
Countries
China
Contacts
Primary ContactJoshua GUO
Outcome results
None listed