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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

1
Tianjin Medical University Cancer Institute & Hospital300000, TianjinTianjin Municipality, China

Sponsors and collaborators

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor