ROS1 Fusion-Positive Lung AdenocarcinomaNCT07700836
Preoperative ROS1-TKI Therapy for ROS1 Fusion-Positive Locally Advanced Lung Adenocarcinoma
An observational study of ROS1 Fusion-Positive Lung Adenocarcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ROS1 Fusion-Positive Lung Adenocarcinoma
- What is being tested?
- ROS1-TKI Therapy
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 17 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital & Institute, Beijing, Beijing 100142
Beijing, Beijing Municipality, 100142
About this study
Official title: 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.
- Conditions
- ROS1 Fusion-Positive Lung Adenocarcinoma
- Being tested
- ROS1-TKI Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROS1-TKI TherapyDrug
Preoperative ROS1 tyrosine kinase inhibitor therapy, including entrectinib or crizotinib, administered according to routine clinical practice before surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative ROS1-TKI Therapy Cohort | Patients with ROS1 fusion-positive locally advanced lung adenocarcinoma who received ROS1-TKI therapy before surgical resection. Receives: Drug: ROS1-TKI Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate
Proportion of patients with 10% or fewer residual viable tumor cells in the resected primary tumor.
Measured: At surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jul 2021
- Primary completion3 Sep 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ROS1 Fusion-Positive Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Nan, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700836
- Sponsor's protocol ID
- 2025YJZ132
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative ROS1-TKI Therapy for ROS1 Fusion-Positive Locally Advanced Lung Adenocarcinoma: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07700836
- Acronym / sponsor ID
- 2025YJZ132
- Conditions
- ROS1 Fusion-Positive Lung Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative ROS1-TKI Therapy Cohort | – | Drug: ROS1-TKI TherapyPatients with ROS1 fusion-positive locally advanced lung adenocarcinoma who received ROS1-TKI therapy before surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROS1-TKI TherapyPreoperative ROS1 tyrosine kinase inhibitor therapy, including entrectinib or crizotinib, administered according to routine clinical practice before surgical resection. | Drug | Preoperative ROS1-TKI Therapy Cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ROS1 Fusion-Positive Lung Adenocarcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate (time frame: At surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.