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New drug cocktail aims to boost lung cancer surgery success

NCT ID NCT07642024

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests whether adding a new drug called BL-B01D1 to the standard targeted therapy osimertinib can improve outcomes for people with a specific type of lung cancer (EGFR-mutated non-small cell lung cancer) that can be removed with surgery. About 90 participants will receive the drug combination before and after surgery. The main goal is to see if the tumor shrinks significantly or disappears by the time of surgery.

What this could mean

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

Active substance
BL-B01D1 (izalontamab brengitecan) combined with osimertinib
What this could lead to
If successful, this combination could become a new standard perioperative therapy to improve outcomes for patients with EGFR-mutated lung cancer.
What could go wrong
This is an early-to-mid-stage trial with only 90 participants. The combination may cause significant side effects, and results may not generalize 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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 90 people

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

Started

Jul 2026

Expected to finish

Dec 2032

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 to 75 years

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: 1. Voluntarily sign informed consent and agree to comply with the protocol requirements; 2. Aged ≥18 years and ≤75 years, regardless of gender; 3. Expected survival time ≥3 months; 4. Patients with non-small cell lung cancer; 5. One of the EGFR sensitive mutation types detected in the tumor tissue; 6. Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples; 7. Undergo pulmonary function testing within 28 days prior to the first dose; 8. ECOG performance status score of 0 or 1; 9. No severe cardiac dysfunction; 10. Organ function levels must meet the required criteria; 11. Urine protein ≤1+ or \<1000 mg/24h; 12. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be lactating; all enrolled trial participants must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment. Exclusion Criteria: 1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types; 2. Trial participants who subsequently receive only segmentectomy or wedge resection; 3. Trial participants deemed surgically inoperable by the study center's surgical evaluation; 4. Undergoing major surgery within 4 weeks prior to the first dose, among others; 5. Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others; 6. Receiving long-term systemic corticosteroid therapy with prednisone \>10 mg/day within 2 weeks prior to randomization, among others; 7. History of severe heart disease or cerebrovascular disease; 8. Prolonged QTc interval, complete left bundle branch block, etc.; 9. Any thrombotic event within 6 months prior to screening; 10. Trial participants with known or suspected interstitial lung disease, among others; 11. Diagnosis of active malignant tumors within 5 years prior to study randomization; 12. Hypertension inadequately controlled by two antihypertensive medications; 13. Trial participants with poorly controlled blood glucose; 14. Severe infection occurring within 4 weeks prior to study randomization, among others; 15. Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.; 16. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.; 17. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent; 18. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent; 19. Inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, etc.; 20. History of allergy to the investigational drug, etc.; 21. History of solid organ transplantation, autologous or allogeneic stem cell transplantation; 22. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection; 23. History of severe neurological or psychiatric disorders; 24. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization; 25. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.

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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

    2 sites. 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, Shanghai Municipality, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

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