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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07700836
Enrollment
12
Registered
2026-07-14
Start date
2021-07-01
Completion date
2025-11-17
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ROS1 Fusion-Positive Lung Adenocarcinoma

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.

Interventions

DRUGROS1-TKI Therapy

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

Sponsors

Peking University Cancer Hospital & Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Major pathological response rateAt surgical resectionProportion of patients with 10% or fewer residual viable tumor cells in the resected primary tumor.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026