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 | Not Yet Recruiting Phase 2

• 1 other identifier: E20260033
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer (SCLC); SCLC, Extensive Stage

Keywords

Small Cell Lung Cancer (SCLC); bemotuzumab; anlotinib; hypofractionated radiotherapy; Induction therapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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 Outcomes (3)

• Objective Response Rate (ORR)

  From enrollment until the first documented CR or PR, assessed up to approximately 24 months.

• Overall Survival (OS)

  From enrollment until death from any cause, assessed up to approximately 24 months.

• Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)

  From first dose of study drug until 28 days after the last dose, assessed up to approximately 24 months.

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Interventions

Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy COMBINATION_PRODUCT

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.

Also known as: Anlotinib Hydrochloride, Bemotuzumab Injection, Fucovee, Hypofractionated Radiotherapy

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib; Drug Therapy; Radiotherapy; Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Dose Fractionation, Radiation; Radiotherapy Dosage

Study Officials

• Dingzhi Huang, Doctor

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Ningbo Liu, Doctor

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingzhi Huang, Doctor

CONTACT

86-22-23340123; dingzhih72@163.com

Ningbo Liu, Doctor

CONTACT

+8615602036608; liuningbo@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. No masking (blinding) is used.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, exploratory study. All enrolled participants receive the same intervention sequence.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)