Actively Recruiting
A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
160
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase Ib: To observe the safety and tolerability of the combination of SI-B001 and SI-B003, and to determine the recommended dose of phase II clinical study (RP2D) in the indication of locally advanced or metastatic non-small cell lung cancer. Phase II: To evaluate the efficacy of SI-B001+SI-B003 combination with or without chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer.
CONDITIONS
Official Title
A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and comply with protocol requirements
- No gender restrictions
- Age 18 years or older and 75 years or younger
- Expected survival time of 3 months or more
- Agree to complete ctDNA testing during screening
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer
- Agree to provide archived or fresh tumor tissue samples from primary or metastatic lesions
- Have at least one measurable lesion as defined by RECIST v1.1
- Performance status score of 0 or 1 on the ECOG scale
- Toxicity from prior anti-tumor therapy has recovered to Grade 1 or lower as defined by NCI-CTCAE v5.0
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) 50% or higher
- Organ function levels meet requirements without need for transfusion, albumin, colony-stimulating factors, any cell growth factors, or platelet-raising drugs within 14 days before first dose
- Coagulation function: International Normalized Ratio (INR) 1.5 or less, and activated partial thromboplastin time (APTT) 1.5 times the upper limit of normal or less
- Urine protein 1+ or 1000 mg/24h or less
- Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before first dose until 24 weeks after last dose
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before first dose
You will not qualify if you...
- Relevant genetic alterations indicated before signing informed consent
- Phase II patients suitable for and willing to undergo local therapy or who have received systemic chemotherapy
- Symptomatic brain parenchymal or leptomeningeal metastases deemed ineligible by investigator
- Participation in any other clinical trial within 4 weeks prior to administration of this trial's investigational product
- Use of chemotherapy, biologic therapy, immunotherapy, or similar within 4 weeks or 5 half-lives prior to first dose, or palliative radiotherapy, small-molecule targeted therapy, or other antitumor treatments within 2 weeks before first dose
- Major surgery within 4 weeks prior to first dose
- Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks before study drug administration
- Pulmonary diseases graded 3 or higher, history or current or suspected interstitial lung disease
- Concurrent pulmonary disease causing significant respiratory impairment
- Unstable thrombotic events requiring treatment within 6 months before screening (excluding catheter-related thrombosis)
- Active infection requiring intravenous anti-infective therapy
- Imaging showing tumor invasion or encasement of major blood vessels with bleeding risk after treatment
- Prior immunotherapy causing Grade 3 or higher immune-related adverse events or Grade 2 or higher immune-related myocarditis
- Use of live attenuated vaccines within 4 weeks before first dose
- Use of immunomodulatory drugs within 14 days before first dose
- Risk of active autoimmune diseases or history of autoimmune diseases
- History of other malignancies within 5 years before first dose
- Positive for HIV antibodies, active tuberculosis, active hepatitis B or hepatitis C infection
- Poorly controlled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
- History of severe cardiovascular or cerebrovascular diseases
- Significant serous cavity effusion, symptomatic or poorly controlled effusion
- History of allogeneic stem cell, bone marrow, or organ transplantation
- History of hypersensitivity to recombinant humanized antibodies or any excipients of SI-B001 or SI-B003
- History of autologous or allogeneic stem cell transplantation
- Pregnant or lactating women
- Any other condition deemed unsuitable for participation 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 Pulmonary 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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