Non-Small Cell Lung CancerNCT07008287
Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
An observational study of Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) with brain metastases. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Taletrectinib
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to Dec 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ROS1-positive non-small cell lung cancer (NSCLC) with brain metastasis
Who may be able to join
- Patients must meet all of the following criteria to be eligible for enrollment into the study:
- Age ≥ 18 years.
- Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).
- At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.
- Radiographically confirmed brain metastasis(es) , with stable CNS symptoms within 2 weeks prior to enrollment.
- Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
- Considered by the investigator to be candidates for Taletrectinib treatment ; OR Patients with ≤6 months of prior Taletrectinib exposure enrolled retrospectively. (Note: For retrospective patients deceased before enrollment, waiver of informed consent is required. Patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible).
- Signed Informed Consent.
Who cannot join
- Patient presenting with any of the following criteria will not be included in the study：
- Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.
- Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .
- Pregnancy or breastfeeding.
- Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.
- Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 201107
Joshua GUO, +86-18819430923, joshua.guo@innoventbio.com
About this study
Official title: A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) with brain metastases. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Taletrectinib
- 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.
TaletrectinibDrug
Also called AB-106, DS-6051b
Taletrectinib, 600mg, QD
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | ROS1 fusion positive NSCLC patients with brain metastases who received taletrecitnib Receives: Drug: Taletrectinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 6 months
iORR
Intracranial objective response rate
Measured: 6 months
Secondary outcomes (8)
PFS
Progression free survival
Measured: 25 months
DoR
Duration of response
Measured: 25 months
DCR
Disease control rate
Measured: 6 months
OS
Overall survival
Measured: 51 months
iPFS
Intracranial progress free survival
Measured: 25 months
iDoR
Intracranial duration of response
Measured: 6 months
iDCR
Intracranial disease control rate
Measured: 6 months
Adverse events
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE 5.0
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start4 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 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.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008287
- Sponsor's protocol ID
- IBI344-RWS-002
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases
- ClinicalTrials.gov ID
- NCT07008287
- Acronym / sponsor ID
- IBI344-RWS-002
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Jun 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.
This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) with brain metastases. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | – | Drug: TaletrectinibROS1 fusion positive NSCLC patients with brain metastases who received taletrecitnib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ROS1-positive non-small cell lung cancer (NSCLC) with brain metastasis
Key inclusion criteria (8 listed)
- Patients must meet all of the following criteria to be eligible for enrollment into the study:
- Age ≥ 18 years.
- Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).
- At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.
- Radiographically confirmed brain metastasis(es) , with stable CNS symptoms within 2 weeks prior to enrollment.
Key exclusion criteria (6 listed)
- Patient presenting with any of the following criteria will not be included in the study：
- Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.
- Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .
- Pregnancy or breastfeeding.
- Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.
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 |
|---|---|---|
| TaletrectinibAlso: AB-106, DS-6051bTaletrectinib, 600mg, QD | Drug | cohort 1 |
Primary outcome
ORR
Time frame: 6 months
Objective response rate
iORR
Time frame: 6 months
Intracranial objective response rate
8 secondary outcomes
PFS
Time frame: 25 months
DoR
Time frame: 25 months
DCR
Time frame: 6 months
OS
Time frame: 51 months
iPFS
Time frame: 25 months
iDoR
Time frame: 6 months
iDCR
Time frame: 6 months
Adverse events
Time frame: 25 months
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 22 Jul 2025.
- Individual participant dataSharing planned: No
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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.
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 Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. 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 8 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 22 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 months). The study lists 2 primary outcomes in all. 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 22 Jul 2025.