Phase I/II Study on Enhancing Response to Atezolizumab and Chemotherapy with Total Body Radiation for Extensive Stage Small Cell Lung Cancer

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06110572

Provider View

This clinical trial is exploring whether adding low-dose radiation to the whole body and higher-dose radiation to cancer areas can improve the effectiveness of standard treatment with atezolizumab and chemotherapy in patients with extensive stage small cell lung cancer.

Patient Parameters

Program Overview

This study aims to find out if using low-dose radiation to the entire body and higher-dose radiation to specific cancer areas, along with the immunotherapy drug atezolizumab and chemotherapy drugs carboplatin and etoposide, can improve treatment outcomes for patients with extensive stage small cell lung cancer (ES-SCLC). The study will assess the safety and effectiveness of this combined approach, which may help the immune system better attack cancer cells and prevent them from growing and spreading.

Description

The study is divided into two phases:

Induction Phase:

  • Patients will receive chemotherapy drugs carboplatin and etoposide, along with the immunotherapy drug atezolizumab, over a 21-day cycle for four cycles.
  • During the first cycle, patients will also receive low-dose radiation to the whole body and higher-dose radiation to known cancer areas.

Maintenance Phase:

  • Patients will continue to receive atezolizumab every 21 days for up to 12 cycles.

Throughout the study, patients will undergo regular CT and MRI scans to monitor the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every 3-4 months for up to three years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of extensive stage small cell lung cancer.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control with appropriate treatments.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during and for five months after treatment.
  • Men must agree to use condoms or abstain from intercourse during and for five months after treatment.
  • Be eligible for immunotherapy-based treatments as determined by the study doctor.
  • Be able to provide written informed consent to participate in the study.

Exclusion Criteria

  • Have had major surgery within four weeks before starting the study.
  • Have significant infections or cardiovascular disease within three months before starting the study.
  • Have uncontrolled high blood pressure.
  • Have had another type of cancer within the past three years, except for certain non-threatening cancers.
  • Have received prior chemotherapy or immunotherapy for the current cancer, except for one cycle of first-line treatment.
  • Have received prior radiation that would interfere with the study treatment.
  • Have received a live vaccine within 28 days before starting the study.
  • Be participating in another clinical trial.
  • Have uncontrolled fluid buildup around the lungs or heart.
  • Have a history of autoimmune diseases or immune deficiencies, with some exceptions.
  • Have severe lung diseases or infections within four weeks before starting the study.
  • Be pregnant or breastfeeding, or planning to become pregnant during the study or within five months after treatment.

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