NCT07358676RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 14 Jan 2026
- Start date
- Feb 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07358676
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From Feb 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \*\*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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.