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Recruiting Phase 2

A Study of Bemotuzumab Plus Chemotherapy and Anlotinib Induction Followed by Bemotuzumab, Anlotinib and Consolidative Thoracic Radiotherapy in Extensive-Stage Small Cell Lung Cancer

NCT07358676 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-02-01
Last updated
2026-07-06

Condition(s) studied

Small Cell Lung Cancer (SCLC)SCLC, Extensive Stage

Investigational drug(s) / intervention(s)

Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy

Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy: This 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
\*\*Inclusion Criteria:\*\* 1. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per VALG staging. 2. No prior systemic therapy for ES-SCLC. 3. At least one measurable lesion as defined by RECIST 1.1 criteria. 4. Age 18-75 years. 5. ECOG performance status of 0-2. 6. Life expectancy of ≥3 months. 7. 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%. 8. For females of childbearing potential: negative serum pregnancy test within 3 days prior to dosing and agreement to use highly effective contraception. 9. For males: agreement to use barrier contraception. 10. Willing and able to provide written informed consent and comply with study procedures. \*\*Exclusion Criteria:\*\* 1. Symptomatic brain metastases. (Asymptomatic, treated, and stable brain metastases for ≥1 month without steroids are allowed). 2. Prior thoracic radiotherapy for SCLC. 3. Prior treatment with anti-angiogenic agents (e.g., anlotinib, bevacizumab) or anti-PD-1/PD-L1 therapies. 4. Factors affecting oral medication intake (e.g., inability to swallow, major gastrointestinal resection). 5. Uncontrolled effusions requiring repeated drainage (pleural, pericardial, or ascites). 6. Imaging evidence of tumor invasion of major blood vessels or high risk of fatal hemorrhage as judged by the investigator. 7. 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. 8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment. 9. Arterial/venous thrombotic events within 6 months prior to enrollment (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism). 10. Active autoimmune disease requiring systemic treatment within 2 years prior to first dose. 11. Any other condition that, in the investigator's judgment, increases risk or renders the patient unsuitable for the study.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — From enrollment until disease progression or death from any cause, assessed up to approximately 24 months.
    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).

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358676 on ClinicalTrials.gov ↗ ← All trials in China