Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases

NCT07008287 | Recruiting

• 1 other identifier: IBI344-RWS-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate

  6 months

• iORR

  Intracranial objective response rate

  6 months

Secondary Outcomes (8)

• PFS

  25 months

• DoR

  25 months

• DCR

  6 months

• OS

  51 months

• iPFS

  25 months

Study Arms (1)

cohort 1

ROS1 fusion positive NSCLC patients with brain metastases who received taletrecitnib

Drug: Taletrectinib

Interventions

Taletrectinib DRUG

Taletrectinib, 600mg, QD

Also known as: AB-106, DS-6051b

cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ROS1-positive non-small cell lung cancer (NSCLC) with brain metastasis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 201107, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

taletrectinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)