Scientists investigate drug resistance in lung cancer treatment
NCT ID NCT07199959
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This observational study aims to understand how ROS1-positive non-small cell lung cancer develops resistance to the drug entrectinib. Researchers will analyze blood and tissue samples from 38 patients who have already taken entrectinib as part of their regular care. By looking at genetic changes, they hope to identify the mechanisms behind acquired resistance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Entrectinib
- What this could lead to
- If successful, this could help doctors understand why some lung cancers stop responding to entrectinib, potentially leading to better treatment strategies.
- What could go wrong
- This is a small, observational study that only looks back at past data. It won't test new treatments, and findings may not apply to all patients.
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 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Clinically staged as IIIB-IV, unresectable locally advanced, recurrent, or metastatic ROS1 fusion positive non small cell lung cancer
- Ages
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18 years and older
- Sex
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Anyone
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 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; * 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. Exclusion Criteria: * 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.
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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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Fudan university shanghai cancer center
RECRUITINGShanghai, Shanghai Municipality, China
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