Bemotuzumab with chemotherapy and anlotinib, then targeted radiotherapy for extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, open-label trial enrolling about 25 patients with previously untreated extensive-stage small cell lung cancer. Participants receive induction therapy with bemotuzumab plus standard chemotherapy and anlotinib, followed by consolidation therapy with bemotuzumab, anlotinib, and thoracic radiotherapy, then maintenance with bemotuzumab and anlotinib. The study's primary goals are to see if the regimen can extend progression-free survival and to evaluate safety. Endpoints include PFS, response rates, and adverse events. Eligibility requires confirmed ES-SCLC, measurable disease, good organ function, and acceptable performance status.

Why it matters

Who can join: the full rules

\*\*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.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Dingzhi Huang, Doctor — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Dingzhi Huang, Doctor
• Email: dingzhih72@163.com
• Phone: 86-22-23340123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.