Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC... | NCT07199010

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

NCT07199010

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Status

Not yet recruiting

Last Update Posted

Sep 30, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Non-small Lung Cancer

Interventions

Taletrectinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2025Estimated

Primary Completion Date

Sep 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Sep 22, 2025

First Submission Date that Met QC Criteria

Sep 22, 2025

First Posted Date

Sep 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		ROS1 fusion positive NSCLC patients following Entrectinib progression who received taletrecitnib	Drug: Taletrectinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taletrectinib	Drug	Taletrectinib, 600mg, QD	Cohort 1	AB-106

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	Objective response rate	6 months

Secondary Outcomes

Measure	Description	Time Frame
PFS	Description: Progression free survival	25 months
DoR	Duration of response	25 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with ROS1-positive non-small cell lung cancer (NSCLC) who progressed following Entrectinib treatment

Sampling Method

Non-Probability Sample