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

January 14, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a novel three-phase sequential treatment strategy: patients first receive induction therapy with Bemotuzumab combined with standard chemotherapy and Anlotinib; those achieving disease control then proceed to consolidation therapy with Bemotuzumab, Anlotinib, and concurrent thoracic radiotherapy; followed by a maintenance phase with Bemotuzumab plus Anlotinib. The primary objectives are to assess the regimen's efficacy in prolonging progression-free survival (PFS) and to observe its safety profile. The study plans to enroll approximately 25 patients.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

**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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group

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.
Combination product: 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.

Other Names:
  • Hypofractionated Radiotherapy
  • Anlotinib Hydrochloride
  • Bemotuzumab Injection
  • Fucovee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 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).
From enrollment until disease progression or death from any cause, assessed up to approximately 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From enrollment until the first documented CR or PR, assessed up to approximately 24 months.
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.
From enrollment until the first documented CR or PR, assessed up to approximately 24 months.
Overall Survival (OS)
Time Frame: From enrollment until death from any cause, assessed up to approximately 24 months.
OS is defined as the time from enrollment to death from any cause.
From enrollment until death from any cause, assessed up to approximately 24 months.
Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)
Time Frame: From first dose of study drug until 28 days after the last dose, assessed up to approximately 24 months.
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.
From first dose of study drug until 28 days after the last dose, assessed up to approximately 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Dingzhi Huang, Doctor, Tianjin Medical University Cancer Institute and Hospital
  • Principal Investigator: Ningbo Liu, Doctor, Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20260033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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