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

NCT ID: NCT07199010

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-12-31

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.

Conditions

Non-small Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

ROS1 fusion positive NSCLC patients following Entrectinib progression who received taletrecitnib

Taletrectinib

Intervention Type: DRUG

Taletrectinib, 600mg, QD

Interventions

Taletrectinib

Taletrectinib, 600mg, QD

Intervention Type: DRUG

Other Intervention Names

AB-106; DS-6051b

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital (The East Hospital Affiliated to Tongji University)

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Joshua GUO

Role: CONTACT

joshua.guo@innoventbio.com

+86-18819430923

Facility Contacts

Joshua GUO

Role: primary

joshua.guo@innoventbio.com

+86-18819430923

Other Identifiers

IBI344-RWS-001

Identifier Type: -

Identifier Source: org_study_id