Testing Radiation Therapy with Atezolizumab for Extensive Stage Small Cell Lung Cancer: The RAPTOR Trial

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04402788

Provider View

This clinical trial is exploring whether adding radiation therapy to the usual treatment with the immunotherapy drug atezolizumab can improve outcomes for patients with extensive stage small cell lung cancer that has spread beyond the lungs.

Patient Parameters

Program Overview

This study is testing if adding radiation therapy to the standard treatment with atezolizumab, an immunotherapy drug, can help control small cell lung cancer that has spread outside the lungs. Atezolizumab helps the immune system attack cancer cells, while radiation uses high-energy rays to kill cancer cells and shrink tumors. The trial aims to see if this combination can delay the growth or spread of cancer more effectively than atezolizumab alone.

Description

The study has two main goals:

  1. To compare how long patients live without their cancer getting worse when treated with atezolizumab plus radiation versus atezolizumab alone.
  2. To compare the overall survival of patients receiving the combination treatment versus atezolizumab alone.

Secondary goals include assessing the side effects of the treatments and understanding how the number of tumors affects treatment outcomes. The study will also explore how the amount of cancer present before treatment relates to the benefits of the therapy.

Participants will be randomly assigned to one of two groups:

  • Group 1: Receives atezolizumab through an IV every 21 days.
  • Group 2: Receives atezolizumab through an IV every 21 days and radiation therapy daily for five weeks.

Throughout the trial, participants will have various scans and tests, including PET/CT, CT, and MRI, and provide blood and tissue samples. After completing the treatment, participants will have follow-up visits every three months for two years, then every six months for three years, and annually after that.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with extensive stage small cell lung cancer.
  • Cancer has responded partially or is stable after initial treatment with chemotherapy and atezolizumab.
  • Must be enrolled within a specific time after completing initial treatment.
  • Have measurable cancer and no more than three liver metastases.
  • Meet specific health criteria, including blood counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • HIV-positive patients must have an undetectable viral load and stable treatment.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Cancer has spread to more than three liver sites or other critical areas.
  • Have another cancer that could interfere with the study.
  • Previous radiation in the chest that overlaps with the study treatment area.
  • Active autoimmune diseases or severe health conditions that could complicate treatment.
  • Active infections like tuberculosis or significant liver disease.
  • Pregnant or breastfeeding women.
  • History of organ transplant or certain lung conditions.
  • Recent heart problems or other serious health issues.

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