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Taking people in ChinaPhase 2

Bemotuzumab, anlotinib, chemotherapy and chest radiation for extensive-stage small cell lung cancer

Tests bemotuzumab and anlotinib with chemotherapy and radiation in untreated extensive-stage small cell lung cancer.

Key facts

Who runs it
Tianjin Medical University Cancer Institute and Hospital
Where
Tianjin, ChinaSee the site
Trial code
Registry title
A Study of Bemotuzumab Plus Chemotherapy and Anlotinib Induction Followed by Bemotuzumab, Anlotinib and Consolidative Thoracic Radiotherapy in Extensive-Stage Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
People taking part
25 people, planned
Started
1 Feb 2026
Expected to end
1 Jan 2028
Type of study
Interventional
Treatments tested
  • Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy
Record updated
6 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with extensive-stage small cell lung cancer who have not yet had any drug treatment for it.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Extensive-stage small cell lung cancer (ES-SCLC) per VALG staging, confirmed by tissue or cell tests, with at least one lesion that can be measured (RECIST 1.1).
Earlier treatment
No earlier systemic therapy for ES-SCLC. No earlier chest radiotherapy for SCLC. No earlier anti-angiogenic drugs (for example anlotinib, bevacizumab) or anti-PD-1/PD-L1 therapy.

Main reasons for not taking part

  • Brain metastases that cause symptoms
  • Fluid build-up that needs repeated drainage
  • Tumor growing into major blood vessels, or high risk of fatal bleeding
  • Bleeding problems, or coughing up blood (more than 1 tablespoon daily within 3 months)
  • Blood clot events within 6 months, or active autoimmune disease needing systemic treatment within 2 years

The registry criteria, word for word

Show all 22 criteriaShow less

Other 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 0-2
  • 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; 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%
  • For females of childbearing potential: negative serum pregnancy test within 3 days prior to dosing and agreement to use highly effective contraception
  • For males: agreement to use barrier contraception
  • Willing and able to provide written informed consent and comply with study procedures; **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
  • Any other condition that, in the investigator's judgment, increases risk or renders the patient unsuitable for the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaContact: Ningbo Liu, DoctorTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Experimental GroupTreatment being tested

    Participants receive a multi-phase experimental regimen. Induction (4 cycles, q3w): Bemotuzumab (1200 mg IV, Day 1) combined with investigator's choice of platinum-etoposide chemotherapy (Carboplatin AUC=5 or Cisplatin 75-80 mg/m² on Day 1, plus Etoposide 100 mg/m² IV on Days 1-3) and oral Anlotinib (12 mg once daily on Days 1-14, then 7 days off). Consolidation (2 cycles, q3w): Bemotuzumab (same dose) + Anlotinib (same schedule) with concurrent hypofractionated thoracic radiotherapy (5 Gy per fraction for 5 fractions). Maintenance: Bemotuzumab (q3w) + Anlotinib (same schedule) until disease progression, unacceptable toxicity, or other withdrawal criteria. Anlotinib dose may be reduced (12mg → 10mg → 8mg) for managing toxicity.

    Treatment: Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Bemotuzumab, anlotinib, chemotherapy and chest radiation for extensive-stage small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07358676, who can take part
Publications
Record updated
6 July 2026