BL-B01D1 with Osimertinib before/around surgery for EGFR-mutant resectable NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, multicenter study in adults with resectable NSCLC carrying EGFR mutations. Participants will receive BL-B01D1 in combination with osimertinib, with or without standard chemotherapy components such as carboplatin, pemetrexed, or cisplatin, prior to or around the time of surgery. The trial aims to assess safety and efficacy in a registrational setting. Enrollment requires adequate organ function, performance status, and tumor tissue availability for biomarker confirmation. Locations include two Shanghai hospitals, with Sichuan Baili Pharmaceutical as the lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.