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

NCT07700836 | Completed DMC

• 1 other identifier: 2025YJZ132
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

ROS1 Fusion-Positive Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Major pathological response rate

  Proportion of patients with 10% or fewer residual viable tumor cells in the resected primary tumor.

  At surgical resection

Study Arms (1)

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

ROS1-TKI Therapy DRUG

Preoperative ROS1 tyrosine kinase inhibitor therapy, including entrectinib or crizotinib, administered according to routine clinical practice before surgical resection.

Preoperative ROS1-TKI Therapy Cohort

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 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute, Beijing, Beijing 100142

Beijing, Beijing Municipality, 100142, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2021
• Primary Completion: September 3, 2025
• Study Completion: November 17, 2025
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CN (1)