Preoperative ROS1-TKI Therapy for ROS1 Fusion-Positive Lo... | NCT07700836

Studies
Preoperative ROS1-TKI Therapy for ROS1 Fusion-Positive Locally Advanced Lung Adenocarcinoma

NCT07700836

Sponsor

Peking University Cancer Hospital & Institute

Status

Completed

Last Update Posted

Jul 15, 2026Actual

Enrollment

12Actual

Phase

Not provided

Conditions

ROS1 Fusion-Positive Lung Adenocarcinoma

Interventions

ROS1-TKI Therapy

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

Jul 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Sep 3, 2025Actual

Completion Date

Nov 17, 2025Actual

First Submitted Date

Jul 8, 2026

First Submission Date that Met QC Criteria

Jul 8, 2026

First Posted Date

Jul 14, 2026Actual

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

Jul 13, 2026

Last Update Posted Date

Jul 15, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wu Nan, Professor, Peking University Cancer Hospital & InstitutePrincipal Investigator

Lead Sponsor

Peking University Cancer Hospital & InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 multicenter retrospective study evaluates preoperative ROS1-TKI therapy in patients with ROS1 fusion-positive locally advanced lung adenocarcinoma. Patients who received ROS1-TKI therapy before surgical resection were retrospectively identified from four tertiary hospitals in China. The study describes clinicopathological characteristics, radiographic response, treatment-related adverse events, surgical outcomes, pathological response, and follow-up outcomes.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preoperative ROS1-TKI Therapy Cohort		Patients with ROS1 fusion-positive locally advanced lung adenocarcinoma who received ROS1-TKI therapy before surgical resection.	Drug: ROS1-TKI Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ROS1-TKI Therapy	Drug	Preoperative ROS1 tyrosine kinase inhibitor therapy, including entrectinib or crizotinib, administered according to routine clinical practice before surgical resection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major pathological response rate	Proportion of patients with 10% or fewer residual viable tumor cells in the resected primary tumor.	At surgical resection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older.
Histologically confirmed lung adenocarcinoma.
ROS1 fusion positivity confirmed in tumor tissue at the DNA or RNA level.
M0 disease at baseline.
Receipt of targeted therapy before surgery.
Surgical resection performed after ROS1-TKI therapy.
Availability of comprehensive clinical, radiographic, treatment, surgical, pathological, and follow-up data.

Exclusion Criteria:

Baseline M1 disease.
Receipt of radiotherapy or immunotherapy before ROS1-TKI therapy.
No surgical resection after ROS1-TKI therapy.
Lack of essential data for endpoint evaluation.

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 fusion-positive locally advanced lung adenocarcinoma who had baseline M0 disease, received ROS1-TKI therapy before surgery, and underwent surgical resection at four tertiary hospitals in China.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Cancer Hospital & Institute, Beijing, Beijing 100142		Beijing	Beijing Municipality	100142	China