An Exploratory Phase II Study of Bemotuzumab Combined With Chemotherapy and Anlotinib as Induction Therapy, Followed by Bemotuzumab, Anlotinib, and Consolidative Thoracic Radiotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 25
Overview
Brief Summary
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.
Detailed Description
This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a novel three-phase sequential treatment strategy: patients first receive induction therapy with Bemotuzumab combined with standard chemotherapy and Anlotinib; those achieving disease control then proceed to consolidation therapy with Bemotuzumab, Anlotinib, and concurrent thoracic radiotherapy; followed by a maintenance phase with Bemotuzumab plus Anlotinib. The primary objectives are to assess the regimen's efficacy in prolonging progression-free survival (PFS) and to observe its safety profile. The study plans to enroll approximately 25 patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
This is an open-label study. No masking (blinding) is used.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •\*\*Inclusion Criteria:\*\*
- •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-
- •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.
Exclusion Criteria
- •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.