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Can a novel drug combo outperform standard chemo for lung cancer?

NCT ID NCT07739186

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This trial is investigating whether a new combination of drugs—BL-B01D1 plus a PD-1/VEGF bispecific antibody—can work better than the current standard treatment (tislelizumab plus chemotherapy) for people with locally advanced or metastatic non-squamous non-small cell lung cancer. The study will compare how well each treatment shrinks tumors and delays cancer progression, as well as overall survival. Participants will be randomly assigned to receive one of the two treatment regimens.

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 a PD-1/VEGF bispecific antibody
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced non-squamous non-small cell lung cancer, potentially improving tumor shrinkage and extending life.
What could go wrong
This is an early-to-mid-stage trial, so the combination may not prove more effective than current standard care. Side effects from the drug combination could also be significant.

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 120 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age ≥ 18 years; 3. Expected survival time ≥ 3 months; 4. Patients with locally advanced non-squamous non-small cell lung cancer; 5. Agree to provide tumor tissue samples obtained at or after diagnosis of locally advanced or metastatic cancer; 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. ECOG performance status score of 0 or 1; 8. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%; 10. Organ function levels must meet the required criteria; 11. Urinary protein ≤ 2+ or \< 1000 mg/24h; 12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must rule out pregnancy; patients must be non-lactating and must use highly effective contraceptive measures throughout the treatment period and for 7 months after the last dose. For male participants whose partners are women of childbearing potential, adequate barrier contraceptive measures must be used throughout the treatment period and for 7 months after the end of treatment. Exclusion Criteria: 1. Presence of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma components, or squamous carcinoma components exceeding 10%; 2. Evidence suggesting the presence of EGFR-sensitive mutations, etc.; 3. Patients who have received prior systemic therapy; 4. Prior receipt of therapies targeting the mechanism of tumor immunity; 5. Prior receipt of antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, etc.; 6. Trial participants who have received prior systemic anti-angiogenic therapy; 7. Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization; 8. History of severe cardiac or cerebrovascular disease; 9. Receiving long-term systemic corticosteroid therapy (e.g., \>10 mg/day prednisone) prior to the first dose; 10. Active autoimmune diseases and inflammatory diseases; 11. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 12. Prolonged QT interval, complete left bundle branch block, etc.; 13. Diagnosis of active malignancy within 3 years before study randomization; 14. Hypertension poorly controlled by two antihypertensive medications; 15. Patients with poorly controlled blood glucose; 16. History of ILD requiring steroid therapy, current ILD, or ≥ grade 2 radiation pneumonitis, etc.; 17. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function; 18. Patients with active central nervous system metastases; 19. Occurrence of severe infection within 4 weeks before study randomization; 20. Presence of large serous cavity effusions, or symptomatic serous cavity effusions, etc.; 21. Imaging findings suggesting tumor invasion or encasement of abdominal, thoracic, or other regions; 22. Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent; 23. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent; 24. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.; 25. History of allergy to recombinant humanized antibodies or allergy to the investigational drug, etc.; 26. History of autologous or allogeneic stem cell transplantation; 27. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection; 28. History of severe neurological or psychiatric disorders; 29. Receipt of other unapproved investigational drugs or treatments within 4 weeks before study randomization; 30. Trial participants who plan to receive or have received live vaccines within 28 days before study randomization; 31. Other conditions that, in the investigator's opinion, make the patient 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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

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