A Study of Bemotuzumab Plus Chemotherapy and Anlotinib Induction Followed by Bemotuzumab, Anlotinib and Consolidative Thoracic Radiotherapy in Extensive-Stage Small Cell Lung Cancer
Recruiting · NCT07358676 · Interventional (participants receive a specific treatment) · Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy
What this trial is about
This is a phase II study evaluating a new combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial phase with the drug Bemotuzumab plus standard chemotherapy and anlotinib, followed by a phase combining Bemotuzumab, anlotinib, and chest radiation. The primary objectives are to assess the efficacy of this approach in delaying cancer growth (progression-free survival) and to evaluate its safety in approximately 25 patients.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
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- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per VALG staging.
- No prior systemic therapy for ES-SCLC.
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- Age 18-75 years.
- ECOG performance status of 0-2.
- Life expectancy of ≥3 months.
- Adequate hematologic and organ function:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L.
- Platelet count ≥ 100 × 10\^9/L.
- Hemoglobin ≥ 80 g/L.
- Creatinine clearance ≥ 50 mL/min.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- AST and ALT ≤ 2.5 × ULN.
- Albumin ≥ 28 g/L.
- INR and APTT ≤ 1.5 × ULN.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- For females of childbearing potential: negative serum pregnancy test within 3 days prior to dosing and agreement to use highly effective contraception.
- For males: agreement to use barrier contraception.
- Willing and able to provide written informed consent and comply with study procedures.
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Exclusion criteria
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- Symptomatic brain metastases. (Asymptomatic, treated, and stable brain metastases for ≥1 month without steroids are allowed).
- Prior thoracic radiotherapy for SCLC.
- Prior treatment with anti-angiogenic agents (e.g., anlotinib, bevacizumab) or anti-PD-1/PD-L1 therapies.
- Factors affecting oral medication intake (e.g., inability to swallow, major gastrointestinal resection).
- Uncontrolled effusions requiring repeated drainage (pleural, pericardial, or ascites).
- Imaging evidence of tumor invasion of major blood vessels or high risk of fatal hemorrhage as judged by the investigator.
- History of significant bleeding tendency or coagulopathy, including clinically significant hemoptysis (\>1 tablespoon daily within 3 months) or significant bleeding within 4 weeks prior to enrollment.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.
- Arterial/venous thrombotic events within 6 months prior to enrollment (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism).
- Active autoimmune disease requiring systemic treatment within 2 years prior to first dose.
- Any other condition that, in the investigator's judgment, increases risk or renders the patient unsuitable for the study.
Where it is running
1 location listed.
- Tianjin Medical University Cancer Institute & Hospital - Tianjin, Tianjin Municipality, China