Study on Pembrolizumab and Radiation Therapy for Treating Non-Small Cell Lung Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02444741

Provider View

This clinical trial is exploring the combination of pembrolizumab, an immunotherapy drug, with two types of radiation therapy to treat patients with non-small cell lung cancer. The study aims to find the best dose and assess how well this combination works in shrinking tumors.

Patient Parameters

Program Overview

This study is testing how well pembrolizumab, an immunotherapy drug, works when combined with two types of radiation therapy to treat non-small cell lung cancer. Pembrolizumab helps the immune system attack cancer cells, while radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. The study will compare two methods of radiation: stereotactic body radiation therapy, which targets tumors precisely with fewer doses, and conventional wide-field radiation therapy. Researchers want to see if combining pembrolizumab with these radiation therapies can kill more cancer cells and improve treatment outcomes.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of pembrolizumab when combined with either stereotactic body radiation therapy (SBRT) or conventional wide-field radiation therapy (WFRT) in patients with metastatic non-small cell lung cancer. They will also identify any side effects. In Phase II, the study will evaluate how well the combination treatment works in shrinking tumors and improving progression-free survival compared to pembrolizumab alone.

Participants will be assigned to different groups based on the size and location of their lung tumors. Some will receive pembrolizumab with SBRT, while others will receive it with WFRT. The treatment will be repeated every 21 days for up to 16 cycles, as long as the cancer does not progress and side effects are manageable.

After completing the treatment, patients will have follow-up visits to monitor their health and the effectiveness of the therapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer or other solid tumors for certain groups.
  • Stage IV metastatic cancer during Phase II.
  • At least one tumor in the chest or liver that can be treated with radiation.
  • Willing to provide informed consent and follow study procedures.
  • Have measurable disease based on specific criteria.
  • Good overall health with a performance status of 0 or 1.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Men must agree to use contraception during the study and for 120 days after the last treatment.
  • Previous radiation to other sites is allowed if at least one measurable site remains untreated.

Exclusion Criteria

  • Currently in another clinical trial or using an investigational device.
  • Have an immune deficiency or are on immunosuppressive therapy.
  • Have active autoimmune diseases that prevent safe radiation therapy.
  • Have had prior radiation to all available tumor sites.
  • Have had recent monoclonal antibody or chemotherapy treatments without recovery from side effects.
  • Have another progressing cancer requiring treatment.
  • Have active brain metastases or carcinomatous meningitis.
  • Have active infections or require systemic treatment for autoimmune diseases.
  • Have interstitial lung disease or active pneumonitis.
  • Have conditions that could interfere with the trial or are not in the best interest of the patient.
  • Pregnant or breastfeeding women, or those planning to conceive during the study.
  • Have a history of HIV, active hepatitis B or C.
  • Have received a live vaccine recently.
  • Have experienced severe side effects from previous radiation or immunotherapy.

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