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Completed

NCT Number: NCT07700836

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

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.

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Key information

Conditions

ROS1 Fusion-Positive Lung Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Cancer Hospital & Institute, Beijing, Beijing 100142

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ROS1-TKI Therapy

Drug

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

Primary outcomes

  1. Major pathological response rate

    Time frame: At surgical resection

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

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.