New combo therapy targets Hard-to-Treat lung cancer

NCT ID NCT07206498

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called WSD0922-FU combined with the standard drug osimertinib for people with advanced non-small cell lung cancer that has a specific genetic change (EGFR mutation). The trial aims to see if the combination is safe and can shrink tumors. About 48 adults whose cancer has progressed on previous treatment or has spread to the brain will participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
WSD0922-FU combined with osimertinib (Tagrisso)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced lung cancer that has stopped responding to standard therapy or has spread to the brain.
What could go wrong
This is an early-phase trial with only 48 participants, so the benefits and risks are not yet well understood. The drug combination may cause side effects or fail to shrink tumors.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 48 people

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

Started

Oct 2025

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

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, gender is not limited; * Locally advanced or metastatic NSCLC confirmed by pathology; * Patients who have been genetically tested to carry EGFR sensitive mutations; * Blood/Tissue samples must be provided for testing; * Must have a minimum life expectancy of \>= 3 months; * At least one measurable tumor lesion according to RECIST version 1.1; ● Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions. * Physical Status (ECOG PS) score was 0-1; * Have full organ function; * Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ; * Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily. Exclusion Criteria: * Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug. * Have previously received more than two EGFR-TKI inhibitors for part A; * Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period. * Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs. * Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy). * Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds. * History of severe allergies, or allergies to any active or inactive ingredients of the study drug; * Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration; * Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema); * Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive . * Patients with interstitial lung disease. * History of severe cardiovascular diseases. * Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher; Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage). * Known alcohol or drug dependence. * Mental disorders or poor compliance; * Pregnant or lactating women; * The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer (NSCLC) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200123, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.