About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy
Treatment groups
Locations
1Sponsors and collaborators
Tianjin Medical University Cancer Institute and Hospital
Lead sponsor