Actively Recruiting
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
100
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study is designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with extensive-stage small cell lung cancer.
CONDITIONS
Official Title
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 75 years
- Expected survival time of at least 3 months
- ECOG performance status of 0 or 1
- Confirmed extensive-stage small cell lung cancer by histopathology or cytology
- Patients who failed or cannot tolerate 3 or more lines of systemic antitumor therapy (Cohort A)
- Patients with previous failure or intolerance to standard therapy (Cohort B Stage I)
- Patients who have not received any systemic antitumor therapy (Cohort B Stage II)
- Consent to provide archival or fresh tumor tissue samples within 3 years, or meet other criteria if unable
- At least one measurable lesion per RECIST v1.1
- Adequate organ function including blood counts, kidney, liver, coagulation, and heart function
- Toxicity from previous therapies returned to grade 1 or less (with some exceptions)
- Negative pregnancy test for premenopausal women and use of effective contraception during and 6 months after treatment
You will not qualify if you...
- Previous treatment with EGFR or HER3 monoclonal antibodies
- Recent antineoplastic therapy within specified washout periods
- Prior systemic therapy in Cohort B Stage II patients
- History of severe immune-related adverse events or myocarditis from immunotherapy
- Use of immunomodulatory drugs within 14 days before study drug
- Severe cardiovascular or cerebrovascular diseases
- Active autoimmune or inflammatory diseases requiring systemic treatment
- Other malignancies progressing or needing treatment within 5 years (with some exceptions)
- History or presence of interstitial lung disease or pulmonary inflammation requiring steroids
- Poorly controlled diabetes or hypertension
- Recent thrombosis or embolism requiring intervention
- Active or treated but unstable central nervous system metastases or carcinomatous meningitis
- Symptomatic or recurrent pleural, pericardial effusion or ascites
- Allergy to study drugs or excipients
- Prior organ or stem cell transplantation
- Active infections including HIV, tuberculosis, hepatitis B or C
- Participation in another clinical trial within 4 weeks
- History of psychotropic drug abuse or uncontrolled mental disorders
- Any other conditions deemed unsuitable 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
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here