Actively Recruiting
A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-05-07
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.
CONDITIONS
Official Title
A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent and follow the protocol requirements
- Any gender
- 18 years old or older
- Expected survival time of 3 months or more
- Histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer
- Documented EGFR sensitive mutations from tumor tissue or blood samples
- Consent to provide archived or fresh tumor tissue samples within 2 years for biomarker testing
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 1 or less
- Toxicity from previous antineoplastic therapy resolved to grade 1 or lower
- No severe cardiac dysfunction with left ventricular ejection fraction 50% or higher
- Adequate organ function without recent blood transfusion or cell growth factor use
- Blood coagulation within defined international standardization ratio and clotting time limits
- Urine protein level 2+ or less, or 1000 mg/24h or less
- Use of highly effective contraception from 7 days before first dose until 6 months after dose for fertile participants
- Negative serum pregnancy test within 7 days before first dose for females of childbearing potential
You will not qualify if you...
- Prior systemic therapy
- Previous treatment with EGFR-TKI
- Participation in another clinical trial within 4 weeks before dosing
- Use of traditional Chinese medicine with radiotherapy within 4 weeks or anti-tumor indications within 2 weeks before study drug
- Major surgery within 4 weeks before first dose
- History of severe heart disease or cerebrovascular disease
- Unstable thrombotic events requiring intervention within 6 months before screening
- QT prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmia
- Previous or current interstitial lung disease requiring steroids or grade 2 or higher radiation pneumonitis
- Severe pulmonary diseases causing significant respiratory impairment
- Severe systemic infection within 4 weeks before screening
- Risk or history of active autoimmune disease
- Other malignancies within 5 years before first dose
- HIV positive, active tuberculosis, active hepatitis B or C infection
- Poorly controlled hypertension despite two drugs
- Poor glycemic control
- Massive or symptomatic effusions poorly controlled
- Active central nervous system metastases
- Tumor invasion or encasement of large blood vessels
- Severe unhealed wounds, ulcers, or fractures within 4 weeks before consent
- Significant bleeding or bleeding tendency within 4 weeks before consent
- History of allogeneic stem cell, bone marrow, or organ transplantation
- Allergy to recombinant humanized antibodies or BL-B01D1 excipients
- Severe neurological or psychiatric illness
- Pregnant or lactating women
- Planned or recent live vaccine within 28 days before randomization
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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