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New drug duo aims to outperform standard pill for common lung cancer

NCT ID NCT06838273

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This phase 3 trial is testing whether adding an experimental IV drug called BL-B01D1 to the standard pill osimertinib works better than osimertinib alone for people with advanced EGFR-mutated non-small cell lung cancer. About 720 participants will be randomly assigned to one of the two treatment groups. The main goal is to see if the combination delays cancer growth longer.

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 (a drug given by IV) combined with osimertinib (a daily pill)
What this could lead to
If successful, this combination could become a new first-line treatment option that delays cancer progression longer than osimertinib alone for people with EGFR-mutated lung cancer.
What could go wrong
This is an early-phase 3 trial, so results are not yet known. The combination may cause more side effects than osimertinib alone, and it might not improve survival or quality of life.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 720 people

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

Started

Feb 2025

Expected to finish

Dec 2028

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: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Age ≥18 years old; 3. Expected survival time ≥3 months; 4. Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer; 5. Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples; 6. Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. ECOG 0 or 1; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period; 12. Urinary protein ≤2+ or \< 1000mg/24h; 13. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Previous histologic or cytological evidence of small cell or mixed small/non-small cell components; 2. Patients with previous systemic therapy; 3. Patients had received EGFR-TKI therapy; 4. Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization; 5. History of severe heart disease and cerebrovascular disease; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded; 7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 8. Were diagnosed with active malignancy within 3 years before randomization; 9. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg); 10. Patients with poor glycemic control; 11. A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease; 12. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 13. Patients with active central nervous system metastasis; 14. Had a severe infection within 4 weeks before randomization; 15. Patients with massive or symptomatic effusions or poorly controlled effusions; 16. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx; 17. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 19. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea; 20. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1; 21. Had autologous or allogeneic stem cell transplantation history; 22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection; 23. A history of severe neurological or psychiatric illness; 24. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization; 25. Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization; 26. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of 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

    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, Shanghai Municipality, China

More trials for these conditions

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