Study on Bevacizumab with Chemoimmunotherapy and Atezolizumab for Extensive Stage Small Cell Lung Cancer with Liver Metastases

Sponsor: Kamya Sankar

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05588388

Provider View

This clinical trial is testing whether adding bevacizumab to the standard treatment of atezolizumab and chemotherapy can help improve treatment outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC) that has spread to the liver.

Patient Parameters

Program Overview

The study aims to find out if adding bevacizumab to the usual treatment of atezolizumab and chemotherapy can help patients with extensive-stage small cell lung cancer (ES-SCLC) and liver metastases by slowing down the cancer's progression and improving survival without the disease getting worse. The study will also check if this combination is safe and tolerable for patients. The treatment is divided into two phases: an induction phase where bevacizumab, atezolizumab, and chemotherapy are given every 21 days for four cycles, and a maintenance phase where bevacizumab and atezolizumab are given every 21 days for up to 12 months or until the cancer progresses or side effects become unacceptable. Participants will have blood tests every 3 weeks and tumor assessments every 6 weeks.

Description

This is a phase II study that will test the effectiveness and safety of a combination of drugs: bevacizumab, atezolizumab, carboplatin, and etoposide (ABCE) for patients with extensive-stage small cell lung cancer (ES-SCLC) that has spread to the liver. The study will also include a maintenance phase with bevacizumab and atezolizumab (AB) for patients who have not received any prior systemic treatment for their cancer.

Eligibility Criteria

Inclusion Criteria

  • Ability to understand and sign a consent form and follow the study requirements.
  • Confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) with liver metastases.
  • Patients with a history of a specific type of lung cancer that has changed to small cell lung cancer and has spread to the liver, who have not had chemotherapy or immunotherapy, are eligible.
  • No previous treatment for ES-SCLC, except for those who had treatment for a limited stage of the disease and have been treatment-free for at least six months.
  • Measurable disease according to specific medical criteria.
  • Patients with treated or untreated brain lesions can participate if there is no progression and certain conditions are met, such as no recent brain radiation or surgery.
  • Good overall health with a performance status score of 0-2.
  • Adequate blood and organ function based on specific lab tests.
  • For patients with hepatitis C, certain conditions must be met regarding the virus's activity and treatment.
  • Negative pregnancy test for women who can have children.
  • Women must agree to use effective birth control during the study and for a period after treatment.
  • Men must agree to use condoms or abstain from intercourse and not donate sperm during and after treatment.

Exclusion Criteria

  • History of certain brain or spinal cord diseases.
  • Recent history of blood clots or significant bleeding issues.
  • Uncontrolled high blood pressure.
  • Tumors near major blood vessels.
  • Recent severe heart or blood vessel problems.
  • Recent significant bleeding or blood disorders.
  • Recent use of certain blood-thinning medications.
  • Recent major surgery or certain medical procedures.
  • Active or history of autoimmune diseases, with some exceptions.
  • Active lung diseases or infections.
  • Significant heart disease or recent heart attack.
  • Recent severe infections or antibiotic use.
  • Previous organ transplants.
  • Other medical conditions that could interfere with the study.
  • Known HIV or hepatitis B infection.
  • Recent use of live vaccines.
  • Recent use of certain medications that suppress the immune system.
  • Allergies to study drugs or their components.
  • Use of traditional herbal medicines.
  • Participation in another clinical trial recently.

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