Study on Durvalumab and Grid Therapy for Non-small Cell Lung Cancer Progressing During or After PACIFIC Treatment

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05443971

Provider View

This clinical trial is exploring the safety and effects of combining durvalumab, an immunotherapy drug, with grid therapy, a type of radiation treatment, for patients with non-small cell lung cancer that has worsened during or shortly after previous treatment with the PACIFIC regimen.

Patient Parameters

Program Overview

This study aims to test if using durvalumab, an immunotherapy drug, along with grid therapy, a specialized form of radiation, can safely and effectively treat non-small cell lung cancer that has progressed during or within six months after treatment with the PACIFIC regimen. Durvalumab helps the immune system attack cancer cells, while grid therapy targets small areas of the tumor with high doses of radiation to kill cancer cells more effectively and spare healthy tissue. The combination may enhance the ability to control the cancer.

Description

Primary Goal:

  • To assess the safety of combining grid therapy with durvalumab using standard criteria for side effects.

Secondary Goals:

  • To evaluate how well the treatment works on cancer that has spread to other parts of the body.
  • To check if new cancer sites develop when the cancer returns locally or in a few areas.
  • To measure the response of the treated tumor using specific criteria.
  • To determine how long patients can stay on durvalumab before needing a different treatment.

Additional Goal:

  • To monitor changes in immune markers in the blood before and after grid therapy.

Treatment Plan:

  • Patients receive durvalumab through an IV every 28 days for up to 24 cycles, as long as the cancer does not worsen or side effects are manageable.
  • Grid therapy is given on the first day of treatment.
  • Starting 7-14 days after grid therapy, patients receive additional radiation therapy for five sessions.
  • Blood samples are collected at the start and throughout the study.

Follow-Up:

  • After treatment, patients are monitored at 30 days and then every 8-12 weeks for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have non-small cell lung cancer previously treated with the PACIFIC regimen.
  • Cancer must have worsened during or within six months after finishing durvalumab treatment.
  • Weigh more than 30 kg.
  • Have a tumor outside the brain that is 4 cm or larger and suitable for grid therapy.
  • Can have brain metastases or multiple cancer sites.
  • Must not have had rapid cancer spread or recent stereotactic body radiation therapy.
  • Can receive standard radiation for other symptoms.
  • Have a performance status score of 0-2, indicating good overall health.
  • Meet specific blood test requirements for hemoglobin, neutrophils, platelets, liver, and kidney function.
  • Negative pregnancy test for those who can become pregnant.
  • Agree to use contraception during and after treatment.
  • Life expectancy of at least 12 weeks.
  • Willing to provide blood samples for research.
  • Agree to return for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing individuals, or those unwilling to use contraception.
  • Have severe health conditions that could interfere with the study.
  • Have active autoimmune diseases requiring treatment, except for certain stable conditions.
  • Have uncontrolled infections or other serious illnesses.
  • Have had a heart attack or severe heart issues recently.
  • Are taking other investigational drugs for cancer.
  • Have allergies to durvalumab or similar drugs.
  • Have had severe side effects from previous immunotherapy.
  • Have another active cancer within the last six months, except for certain types.
  • Have had major surgery recently.
  • Have a history of organ transplant or primary immune deficiency.
  • Have active hepatitis or tuberculosis.
  • Have received a live vaccine recently.
  • Are using immunosuppressive medications, with some exceptions.

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