Extensive-stage Small-cell Lung Cancer
Conditions
Brief summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer.
Interventions
DRUGBL-B01D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGTislelizumab
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGCarboplatin
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGEtoposide
Administration by intravenous infusion 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 No maximum
Healthy volunteers
No
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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. Patients with histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer; 6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesions within 3 years, or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%; 10. Organ function levels must meet the requirements; 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, and the serum pregnancy test must be negative; patients must not be breastfeeding. All enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.
Exclusion criteria
1. Pathology indicates small cell carcinoma containing non-small cell carcinoma components; 2. Patients who have previously received systemic treatment; 3. Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor; 4. Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug; 5. History of severe heart disease or cerebrovascular disease; 6. Receiving long-term systemic corticosteroid therapy at a dose \>10 mg/day of prednisone or equivalent prior to the first dose; 7. Active autoimmune diseases and inflammatory diseases; 8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; 9. Prolonged QT interval, complete left bundle branch block, etc.; 10. Diagnosis of active malignancy within 3 years prior to study randomization; 11. Hypertension inadequately controlled with two antihypertensive medications; 12. Poorly controlled diabetes mellitus; 13. History of interstitial lung disease (ILD)/pneumonitis requiring steroid therapy, etc.; 14. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function; 15. Patients with active central nervous system (CNS) metastases; 16. Severe infection within 4 weeks prior to study randomization; 17. Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.; 18. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx; 19. Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent; 20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent; 21. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea; 22. History of allergy to recombinant humanized antibodies or any excipient component of BL-B01D1; 23. History of autologous or allogeneic stem cell transplantation; 24. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection; 25. History of severe neurological or psychiatric disorders; 26. Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization; 27. Subjects planning to receive or having received live vaccines within 28 days prior to study randomization; 28. Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial due to complications or other circumstances.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 24 months | Overall survival (OS) is defined as the time between the subject's randomization date and subject's death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 24 months | Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death. |
| Objective Response Rate (ORR) | Up to approximately 24 months | Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS). |
| Disease Control Rate (DCR) | Up to approximately 24 months | Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria. |
| Duration of Response (DOR) | Up to approximately 24 months | Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of 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