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Scientists investigate drug resistance in lung cancer treatment

NCT ID NCT07199959

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fudan university shanghai cancer center

    RECRUITING

    Shanghai, Shanghai Municipality, China

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