Non-Small Cell Lung CancerNCT06694129
Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC
An observational study of Non-Small Cell Lung Cancer and ROS1 Gene Rearrangement, run by National Cancer Center, China.
Trial summary
The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, ROS1 Gene Rearrangement, Resistance
- What is being tested?
- Entrectinib
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2027
- How long will I take part?
- 3 Years
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with non-small cell lung cancer exhibiting ROS1 rearrangement.
Who may be able to join
- 1) Histologically or cytologically confirmed non-small cell lung cancer;
- 2) TNM stage of the ninth edition is IIIB, IIIC, or IV;
- 3) ROS1 fusion positive confirmed by one of the following qualified results: next-generation sequencing technology, fluorescence in situ hybridization, reverse transcription polymerase chain reaction;
- 4) No prior systemic chemotherapy, radiation therapy, or surgery;
- 5) Aged 18 years or older;
- 6) ECOG PS score of 0-1.
Who cannot join
- 1) any prior history of NSCLC and/or any prior treatment for NSCLC;
- 2) prior systemic chemotherapy or radiation therapy or surgical treatment;
- 3) the presence of a second primary tumor;
- 4) hypersensitivity to ROS1-TKI or intolerance to it.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.
Read the detailed description
The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.
- Being tested
- Entrectinib
- Keywords
- Non-Small Cell Lung Cancer, ROS1 Gene Rearrangement, Targeted therapy
- 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.
EntrectinibDrug
Also called Rozlytrek
Patients in each cohort were treated with Entrectinib.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | For eligible patients with advanced ROS1-positive NSCLC who have not received TKI treatment, receive entrectinib therapy until disease progression or intolerance. Receives: Drug: Entrectinib | |
| Cohort 2 | For patients with NSCLC who have progressed after receiving first-generation ROS1 TKI crizotinib and meet the eligibility criteria, they can receive entrectinib treatment until disease progression or intolerance. Receives: Drug: Entrectinib | |
| Cohort 3 | For patients with ROS1-positive NSCLC who have failed multi-line therapy, receive entrectinib until disease progression or intolerance. Receives: Drug: Entrectinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: From enrollment to the end of treatment at 1 year.
Secondary outcomes (3)
Objective remission rate
Measured: From enrollment to the end of treatment at 1 year.
Time to CNS progression
Measured: From enrollment to the end of treatment at 1 year.
Overall survival
Measured: From enrollment to the end of treatment at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- National Cancer Center, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Puyuan Xing, National Cancer Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694129
- Sponsor's protocol ID
- NCC4601
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: It involves patient privacy and cannot be disclosed at will.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC
- ClinicalTrials.gov ID
- NCT06694129
- Acronym / sponsor ID
- NCC4601
- Keywords
- Non-Small Cell Lung Cancer, ROS1 Gene Rearrangement, Targeted therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Center, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Nov 2024 (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 purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.
Detailed description
The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: EntrectinibFor eligible patients with advanced ROS1-positive NSCLC who have not received TKI treatment, receive entrectinib therapy until disease progression or intolerance. |
| Cohort 2 | – | Drug: EntrectinibFor patients with NSCLC who have progressed after receiving first-generation ROS1 TKI crizotinib and meet the eligibility criteria, they can receive entrectinib treatment until disease progression or intolerance. |
| Cohort 3 | – | Drug: EntrectinibFor patients with ROS1-positive NSCLC who have failed multi-line therapy, receive entrectinib until disease progression or intolerance. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non-small cell lung cancer exhibiting ROS1 rearrangement.
Key inclusion criteria (6 listed)
- 1) Histologically or cytologically confirmed non-small cell lung cancer;
- 2) TNM stage of the ninth edition is IIIB, IIIC, or IV;
- 3) ROS1 fusion positive confirmed by one of the following qualified results: next-generation sequencing technology, fluorescence in situ hybridization, reverse transcription polymerase chain reaction;
- 4) No prior systemic chemotherapy, radiation therapy, or surgery;
- 5) Aged 18 years or older;
Key exclusion criteria (4 listed)
- 1) any prior history of NSCLC and/or any prior treatment for NSCLC;
- 2) prior systemic chemotherapy or radiation therapy or surgical treatment;
- 3) the presence of a second primary tumor;
- 4) hypersensitivity to ROS1-TKI or intolerance to it.
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 |
|---|---|---|
| EntrectinibAlso: RozlytrekPatients in each cohort were treated with Entrectinib. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Progression free survival
Time frame: From enrollment to the end of treatment at 1 year.
3 secondary outcomes
Objective remission rate
Time frame: From enrollment to the end of treatment at 1 year.
Time to CNS progression
Time frame: From enrollment to the end of treatment at 1 year.
Overall survival
Time frame: From enrollment to the end of treatment at 1 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 19 Nov 2024.
- Individual participant dataSharing planned: No. It involves patient privacy and cannot be disclosed at will.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and ROS1 Gene Rearrangement, run by National Cancer Center, 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 6 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: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Puyuan Xing (+86 135 2100 5935, xingpuyuan@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From enrollment to the end of treatment at 1 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 19 Nov 2024.