Study on Adding Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Without PD-L1 Marker

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04929041

Provider View

This clinical trial is exploring whether adding radiation therapy to the usual treatment of immunotherapy, with or without chemotherapy, can improve outcomes for patients with advanced non-small cell lung cancer that does not have the PD-L1 marker.

Patient Parameters

Program Overview

This study is testing if adding a special type of radiation therapy, called stereotactic body radiation therapy (SBRT), to the usual treatment can help control advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body and does not have the PD-L1 marker. SBRT uses high-energy x-rays to target and kill cancer cells more precisely, potentially causing less damage to normal tissue. The usual treatment involves immunotherapy drugs like nivolumab and ipilimumab, which help the immune system attack cancer cells. The study aims to see if this combination can stop the cancer from growing and help patients live longer.

Description

The main goal of this study is to find out if adding stereotactic body radiation therapy (SBRT) can improve the time patients live without their cancer getting worse (progression-free survival) and overall survival in patients with advanced non-small cell lung cancer (NSCLC) who do not have the PD-L1 marker.

Secondary goals include comparing the side effects between the treatment groups, evaluating how well the cancer responds to treatment, and assessing the quality of life for patients in both groups. The study will also look at changes in the immune system between the groups.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will receive immunotherapy drugs nivolumab and ipilimumab through an IV every 6 weeks for up to 24 months, along with standard care. They will also have regular imaging tests like MRI, CT, or PET scans, and may have blood samples and tissue biopsies taken.

  • Group B: Patients will receive the same immunotherapy treatment as Group A, but will also receive SBRT every other day for three sessions. They will also have regular imaging tests and may have blood samples and tissue biopsies taken.

After completing the study treatment, patients will have follow-up visits every 3 months for 3 years, then every 6 months for up to 5 years, to monitor their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV non-small cell lung cancer (NSCLC) or certain stage III cancers that cannot be treated with combined chemotherapy and radiation.
  • Tumor does not have the PD-L1 marker (less than 1% expression).
  • For non-squamous cancer types, specific genetic tests must be done, and certain mutations that can be treated with oral medications are not allowed.
  • Have at least two cancerous areas, with one that can be measured and one that can be treated with SBRT.
  • Aged 18 years or older.
  • In good overall health, able to carry out daily activities with some restrictions.
  • Have not received more than three weeks of treatment with chemotherapy or immunotherapy for advanced NSCLC.
  • Have not received treatment for non-metastatic cancer within 6 months before joining the study.
  • Not taking certain immune system-affecting drugs recently.
  • Have not had a tissue or organ transplant.
  • No serious ongoing illnesses that would interfere with the study.
  • No current or past lung inflammation requiring steroids.
  • HIV-positive patients must have an undetectable viral load.
  • No active autoimmune diseases requiring treatment in the past 2 years.
  • No active hepatitis B or C infections.
  • No active brain metastases causing symptoms.
  • Not pregnant or nursing, and women of childbearing potential must have a negative pregnancy test.
  • No other active cancers requiring treatment in the past 2 years.
  • No severe allergies to immunotherapy drugs.
  • No recent live vaccines, except for certain flu and COVID-19 vaccines.
  • Meet specific blood count and organ function requirements.

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