NCT05588388

Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases

IIT2022-05-Sankar-BELIEVE: Phase II Study of Bevacizumab in Combination With Chemoimmunotherapy and Maintenance Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Kamya Sankar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to assess whether the addition of bevacizumab to atezolizumab and chemotherapy can improve response to treatment and progression-free survival in patients with extensive-stage small cell lung cancer (ES-SCLC) with liver metastases. The main questions it aims to answer are: * In patients with ES-SCLC with liver metastases, can bevacizumab in combination with atezolizumab and chemotherapy prolong the length of time that the cancer does not progress? * Is bevacizumab safe and tolerable when combined with atezolizumab and chemotherapy in patients with ES-SCLC and liver metastases? The study treatment includes two phases: * Induction phase: bevacizumab will be administered in combination with atezolizumab and chemotherapy on a 21-day cycle for four cycles. * Maintenance: atezolizumab and bevacizumab will be administered every 21 days for up to 12 months, or until unacceptable toxicity or disease progression. Participants will undergo blood tests every 3 weeks and tumor assessments every 6 weeks.

Detailed description

This is a phase II, open-label, multicenter, single-arm study designed to evaluate the efficacy and safety of bevacizumab plus atezolizumab plus carboplatin plus etoposide (ABCE) followed by bevacizumab plus atezolizumab (AB) maintenance in Extensive-Stage Small Cell Lung Cancer patients (ES-SCLC patients) with Liver Metastases (LM) who have received no prior systemic treatment.

Conditions

• Extensive-stage Small-cell Lung Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Bevacizumab	Addition of Bevacizumab to current standard of care treatment (atezolizumab, carboplatin and etoposide) followed by maintenance Bevacizumab plus Atezolizumab for patients with ES-SCLC with LM

Timeline

• Start date: 2024-08-11
• Primary completion: 2026-12-28
• Completion: 2027-12-28
• First posted: 2022-10-20
• Last updated: 2025-11-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study