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

Preoperative ROS1-TKI Therapy for ROS1 Fusion-Positive Locally Advanced Lung Adenocarcinoma: A Multicenter Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: ROS1 Fusion-Positive Lung Adenocarcinoma
• Intervention / Treatment: Drug: ROS1-TKI Therapy

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital & Institute, Beijing, Beijing 100142

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Preoperative ROS1 tyrosine kinase inhibitor therapy, including entrectinib or crizotinib, administered according to routine clinical practice before surgical resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): November 17, 2025

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025YJZ132

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No