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.
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.
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).
Single group
Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy
Combination productThis is a multi-phase combined modality regimen. Induction Phase (4 cycles): Bemotuzumab (1200mg IV, Day1 q3w) + Platinum/Etoposide chemotherapy (Carboplatin \[AUC5\] or Cisplatin \[75-80 mg/m²\] on Day1, plus Etoposide \[100 mg/m² IV, Days1-3\]) + oral Anlotinib (12mg, Days1-14, then 7 days off). Consolidation Phase (2 cycles): Bemotuzumab (same dose) + Anlotinib (same schedule) + concurrent Thoracic Radiotherapy (5 Gy per fraction for 5 fractions). Maintenance Phase: Bemotuzumab (q3w) + Anlotinib until disease progression or unacceptable toxicity. Anlotinib Dose Modification: The dose may be increased to 12mg if well tolerated. For toxicity, it can be reduced sequentially (12mg→10mg→8mg). Treatment is discontinued if 8mg is not tolerated. For subjects at 8mg, one dose re-escalation is permitted if, in the investigator's judgement, clinical benefit is possible and safety is stable.
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression according to RECIST 1.1 criteria or death from any cause, whichever occurs first. Tumor assessments are performed every 6 weeks (every 2 treatment cycles).
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to RECIST 1.1 criteria.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)
The incidence of treatment-emergent adverse events assessed as immune-related and graded ≥3 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Click on the lead sponsor to view all of their trials.
