New drug combo aims to keep lung cancer at bay
NCT ID NCT07640789
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests whether adding a new drug (BL-B01D1) to the standard pill osimertinib can help people with a certain type of Stage III lung cancer stay cancer-free longer. Participants must have an EGFR gene mutation and have already completed chemotherapy and radiation without their cancer growing. The trial will compare the combination against osimertinib alone in about 418 adults.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 418 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 and ≤ 75 years, regardless of gender; 3. Expected survival time ≥ 3 months; 4. Unresectable Stage III non-small cell lung cancer; 5. Detection of one of the EGFR-sensitive mutation types in tumor tissue; 6. Agree to provide archived primary tumor tissue specimens or fresh tissue samples within 1 year; 7. In platinum-based radical chemoradiotherapy, the platinum-containing chemotherapy regimen must include one of the specified drugs in addition to the platinum agent; 8. In platinum-based radical chemoradiotherapy, patients must have received a total radiation dose of 60 Gy ± 10% before randomization; 9. Toxicities from prior chemoradiotherapy must have resolved to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. ECOG performance status score of 0 or 1; 11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%; 12. Organ function levels must meet the requirements; 13. Urine protein ≤ 1+ or \< 1000 mg/24h; 14. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the test must rule out pregnancy; they must not be lactating; all enrolled trial participants must take adequate barrier contraceptive measures throughout the treatment period and for 7 months after treatment ends. Exclusion Criteria: 1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types; 2. The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy; 3. Major surgery within 4 weeks prior to the first dose; 4. Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies/ADCs targeting EGFR and/or HER3; 5. History of severe heart disease or cerebrovascular disease; 6. Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 7. Any thrombotic events such as deep vein thrombosis, arterial thrombosis, or pulmonary embolism within 6 months prior to screening; 8. Diagnosis of active malignancy within 5 years prior to study randomization; 9. Hypertension poorly controlled by two antihypertensive medications; 10. Trial participants with poorly controlled blood glucose levels; 11. Current radiation pneumonitis of Grade ≥2 as defined by CTCAE; 12. Concurrent lung disease resulting in clinically severe respiratory impairment; 13. Severe infection within 4 weeks prior to study randomization; 14. Large serous cavity effusions or symptomatic serous cavity effusions; 15. Imaging findings suggesting tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx; 16. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent; 17. Trial participants with clinically significant bleeding or a clear tendency for bleeding within 4 weeks prior to signing informed consent; 18. Trial participants with a history of inflammatory bowel disease, extensive bowel resection, or immune-mediated enteritis; 19. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug; 20. History of autologous or allogeneic stem cell transplantation; 21. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection; 22. History of severe neurological or psychiatric disorders, or a history of substance abuse, alcoholism, or drug addiction; 23. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization; 24. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other reasons.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cancer Hospital of Shandong First Medical University
RECRUITINGJinan, Shandong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can surgery after chemoradiation boost lung cancer control?
- Step counts may predict trouble during lung cancer therapy
- New pill targets Hard-to-Treat lung cancer in patients who Can't have standard therapy
- New drug cocktail aims to shrink inoperable lung tumors enough for surgery
- New combo therapy aims to stop lung cancer from returning