Non-small Cell Lung Cancer
Conditions
Brief summary
This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.
Interventions
DRUGCarboplatin
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGPemetrexed
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGCisplatin
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGBL-B01D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGOsimertinib
Oral administration for a cycle of 3 weeks.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response (MPR) | Up to approximately 24 months | MPR is defined as the presence of viable tumor tissue ≤10% in the surgical specimen at the time of tumor resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response (pCR) | Up to approximately 24 months | pCR is defined as the absence of any residual tumor (lesions) in the primary tumor upon surgical resection. |
| Event-Free Survival (EFS) | Up to approximately 24 months | EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first. |
| Overall Survival (OS) | Up to approximately 24 months | Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death. |
| Treatment Emergent Adverse Event (TEAE) | Up to approximately 24 months | TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1. |
| Anti-drug antibody (ADA) | Up to approximately 24 months | Frequency of anti-BL-B01D1 antibody (ADA) will be investigated. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed