Non-small Lung CancerNCT07199010
Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression
An observational study of Non-small 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) following Entrectinib progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Lung Cancer
- What is being tested?
- Taletrectinib
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 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) who progressed following Entrectinib treatment
Who may be able to join
- 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.
- Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
- Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.
- 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
- 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
Shanghai East Hospital (The East Hospital Affiliated to Tongji University)
Shanghai, Shanghai Municipality, 200120
Joshua GUO, +86-18819430923, joshua.guo@innoventbio.com
About this study
Official title: A Multicenter, Non-interventional, Observational Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression
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) following Entrectinib progression. 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 Lung Cancer
- Being tested
- Taletrectinib
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 following Entrectinib progression 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
Secondary outcomes (9)
PFS
Description: 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
iORR
Intracranial objective response rate
Measured: 6 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 posted30 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionSep 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 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
- 50 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
- NCT07199010
- Sponsor's protocol ID
- IBI344-RWS-001
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-interventional, Observational Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression
- ClinicalTrials.gov ID
- NCT07199010
- Acronym / sponsor ID
- IBI344-RWS-001
- Conditions
- Non-small Lung Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (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.
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) following Entrectinib progression. 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 following Entrectinib progression 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) who progressed following Entrectinib treatment
Key inclusion criteria (7 listed)
- 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.
- Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).
- Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.
Key exclusion criteria (5 listed)
- 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.
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
9 secondary outcomes
PFS
Time frame: 25 months
DoR
Time frame: 25 months
DCR
Time frame: 6 months
OS
Time frame: 51 months
iORR
Time frame: 6 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 30 Sep 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 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 7 inclusion and 5 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 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 Joshua GUO (+86-18819430923, joshua.guo@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 months). 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.