Non-small Cell Lung Cancer Stage III
Conditions
Brief summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.
Detailed description
In this trial, the treatment group receives BL-B01D1 in combination with osimertinib, while the control group receives osimertinib monotherapy.
Interventions
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 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.
Design outcomes
Primary
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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