New hope for lung cancer patients when first targeted drug stops working
NCT ID NCT07199010
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well the drug taletrectinib works in people with advanced ROS1-positive non-small cell lung cancer whose cancer has gotten worse after treatment with entrectinib. Researchers will follow 50 patients in real-world clinics to see if the drug shrinks tumors and how long it keeps the cancer under control. The goal is to gather practical information on effectiveness and safety outside of a strict clinical trial setting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Taletrectinib (a targeted cancer drug)
- What this could lead to
- If it works, this could offer a new treatment option for people with a specific type of lung cancer that has stopped responding to an earlier drug.
- What could go wrong
- This is an early, small observational study (50 people) that just watches what happens in real-world practice. It may not prove the drug works better than other options, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with ROS1-positive non-small cell lung cancer (NSCLC) who progressed following Entrectinib treatment
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai East Hospital (The East Hospital Affiliated to Tongji University)
Shanghai, Shanghai Municipality, 200120, China
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