RecruitingPhase 2NCT05588388

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


Sponsor

Kamya Sankar

Enrollment

39 participants

Start Date

Aug 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — bevacizumab (which cuts off blood supply to tumors), atezolizumab (an immunotherapy), and standard chemotherapy — for people with advanced small cell lung cancer that has spread to the liver. The goal is to see if adding bevacizumab to the standard treatment improves outcomes. **You may be eligible if...** - You have confirmed extensive-stage small cell lung cancer (SCLC) with liver metastases - You have not previously received chemotherapy or immunotherapy for this cancer - You are well enough to tolerate treatment **You may NOT be eligible if...** - You have had a blood clot (deep vein thrombosis or pulmonary embolism) in the last 3 months - You have poorly controlled high blood pressure (above 150/100) - You have a history of cancer spreading to the lining of the brain (leptomeningeal disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBevacizumab

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


Locations(3)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

V.A. Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

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NCT05588388


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