ROS1 Fusion PositiveNCT07199959
Study on the Mechanism of Acquired Resistance of Entrectinib
An observational study of ROS1 Fusion Positive and Non Small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the mechanism of acquired resistance in first line trearment of ROS1-positive NSCLC with entrectinib. The main question it aims to answer is: what is the acquired resistant mechanism of entrectinib as first line treatment setting in patients? Tissue or blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ROS1 Fusion Positive, Non Small Cell Lung Cancer
- What is being tested?
- venipuncyure and Entrectinib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Clinically staged as IIIB-IV, unresectable locally advanced, recurrent, or metastatic ROS1 fusion positive non small cell lung cancer
Who may be able to join
- Age ≥ 18 years old;
- Histologically or cytologically diagnosed as non-small cell lung cancer (NSCLC);
- Clinically staged as IIIB-IV, unresectable locally advanced, recurrent, or metastatic NSCLC according to the 8th edition of the AJCC Lung Cancer Staging Manual;
- ROS1 fusion detected in tissue, cytological, or liquid biopsy specimens (such as plasma, cerebrospinal fluid, pleural effusion, or ascites) through molecular testing methods such as FISH, RT-PCR, NGS, etc.;
- At least one measurable lesion according to RECIST 1.1 criteria;
- No prior systemic anti-cancer treatment for locally advanced/metastatic disease (such as chemotherapy, targeted therapy, immunotherapy, anti-angiogenic therapy, etc.); patients who have previously received platinum-based adjuvant/neoadjuvant chemo/radiotherapy or radical chemo/radiotherapy for progressive disease are eligible if disease progression occurs more than 6 months after the last treatment;
Show all 10Show fewer
- For patients who have progressed on first-line treatment with entrectinib and have tissue specimens or peripheral blood samples before and after treatment with entrectinib, they may participate in this study;
- For patients who are currently on first-line treatment with entrectinib and have not yet progressed, if they have tissue specimens or peripheral blood samples before treatment with entrectinib and agree to participate in this study and sign an informed consent form to collect tissue specimens or peripheral blood samples at the time of first treatment follow-up progression, they may participate in this study;
- For newly diagnosed patients who have not yet received any drug treatment, those who need first-line treatment with entrectinib according to the clinical standard of care, after agreeing to participate in this study and signing an informed consent form, will have tissue specimens or peripheral blood samples collected before treatment with entrectinib, followed by routine drug use and treatment follow-up, and additional tissue specimens or peripheral blood samples will be collected at the time of first treatment follow-up progression;
- Cooperate with the researchers to provide clinical and pathological data, imaging data, biological specimen collection, follow-up, etc., required for the study process, and agree to use the testing data for this study.
Who cannot join
- Patients with mixed small cell lung cancer components.
- Carrying other clearly druggable targets, such as EGFR sensitive mutations, EGFR exon 20 insertions, ALK fusions, RET fusions, KRAS activating mutations, BRAF V600E mutations, NTRK1/2/3 fusions, ERBB2 exon 20 insertions, MET exon 14 skipping, MET amplification, etc.
- Having received prior systemic treatment (such as chemotherapy, targeted therapy, immunotherapy, anti-angiogenic therapy, etc.).
- Suffering from other malignant tumors within the past 5 years, with the exception of those with very low risks of metastasis or death (5-year RFS rate > 90%, such as early-stage prostate cancer, breast cancer, etc.).
- Having any contraindications to entrectinib treatment.
- Being unable to understand the informed consent form, unable to cooperate with sample collection and follow-up, or refusing to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality
Jialei Pro. Wang, 86+02164175590, luwangjialei@126.com
Xinming Pro. Zhao
About this study
Official title: A Multi-center Retrospective Study of the Mechanism of Acquired Resistance in First Line Treatment of ROS1fusion Positive NSCLC With Entrectinib
The goal of this observational study is to learn about the mechanism of acquired resistance in first line trearment of ROS1-positive NSCLC with entrectinib. The main question it aims to answer is:
what is the acquired resistant mechanism of entrectinib as first line treatment setting in patients?
Tissue or blood samples of participants who have already taken entrectinib as their regular medical care for NSCLC will send for Next gene sequencing for genomic profiles and bioinformatic analysis.
- Conditions
- ROS1 Fusion Positive, Non Small Cell Lung Cancer
- Being tested
- venipuncyure, Entrectinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venipuncyureProcedure or surgery
venipuncture as clinical practical setting
EntrectinibDrug
600mg, oral, once daily
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarker profile
Measured: Analysis will occur when all patient samples have collected. From enrollment to the study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start15 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ROS1 Fusion PositiveStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of Shanghai Jiaotong University
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199959
- Sponsor's protocol ID
- EQTN-IIT-01
- Status last verified
- Sep 2025
- First submitted
- 12 Nov 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Retrospective Study of the Mechanism of Acquired Resistance in First Line Treatment of ROS1fusion Positive NSCLC With Entrectinib
- ClinicalTrials.gov ID
- NCT07199959
- Acronym / sponsor ID
- EQTN-IIT-01
- Conditions
- ROS1 Fusion Positive, Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of Shanghai Jiaotong University
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (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.
The goal of this observational study is to learn about the mechanism of acquired resistance in first line trearment of ROS1-positive NSCLC with entrectinib. The main question it aims to answer is:
what is the acquired resistant mechanism of entrectinib as first line treatment setting in patients?
Tissue or blood samples of participants who have already taken entrectinib as their regular medical care for NSCLC will send for Next gene sequencing for genomic profiles and bioinformatic analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Clinically staged as IIIB-IV, unresectable locally advanced, recurrent, or metastatic ROS1 fusion positive non small cell lung cancer
Key inclusion criteria (10 listed)
- Age ≥ 18 years old;
- Histologically or cytologically diagnosed as non-small cell lung cancer (NSCLC);
- Clinically staged as IIIB-IV, unresectable locally advanced, recurrent, or metastatic NSCLC according to the 8th edition of the AJCC Lung Cancer Staging Manual;
- ROS1 fusion detected in tissue, cytological, or liquid biopsy specimens (such as plasma, cerebrospinal fluid, pleural effusion, or ascites) through molecular testing methods such as FISH, RT-PCR, NGS, etc.;
- At least one measurable lesion according to RECIST 1.1 criteria;
Key exclusion criteria (6 listed)
- Patients with mixed small cell lung cancer components.
- Carrying other clearly druggable targets, such as EGFR sensitive mutations, EGFR exon 20 insertions, ALK fusions, RET fusions, KRAS activating mutations, BRAF V600E mutations, NTRK1/2/3 fusions, ERBB2 exon 20 insertions, MET exon 14 skipping, MET amplification, etc.
- Having received prior systemic treatment (such as chemotherapy, targeted therapy, immunotherapy, anti-angiogenic therapy, etc.).
- Suffering from other malignant tumors within the past 5 years, with the exception of those with very low risks of metastasis or death (5-year RFS rate > 90%, such as early-stage prostate cancer, breast cancer, etc.).
- Having any contraindications to entrectinib treatment.
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 |
|---|---|---|
| venipuncyurevenipuncture as clinical practical setting | Procedure or surgery | – |
| Entrectinib600mg, oral, once daily | Drug | – |
Primary outcome
biomarker profile
Time frame: Analysis will occur when all patient samples have collected. From enrollment to the study completion, an average of 2 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for ROS1 Fusion Positive
RecruitingPhase 2
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity
Non-Small Cell Lung Cancer
Not yet recruitingObservational study
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion
Non-Small Cell Lung Cancer
RecruitingPhase 3
Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)
Non-small Cell Lung Cancer (NSCLC)
Enrolling by invitationObservational study
Integrated Genomics in Oncogene-driven NSCLC With Acquired Resistance
Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation
Active, not recruitingPhase 2
A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene
Non Small Cell Lung Cancer
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.
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 and Non Small Cell Lung Cancer, run by Fudan University 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jialei Wang (18017312369, wangjialei@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarker profile (time frame: Analysis will occur when all patient samples have collected. From enrollment to the study completion, an average of 2 year.). 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 30 Sep 2025.