Study on Staggered Chemo-Immunotherapy with Durvalumab, Pemetrexed, and Carboplatin for Advanced Non-Squamous Lung Cancer

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04163432

Provider View

This clinical trial is testing two different schedules of combining chemotherapy and immunotherapy to treat advanced non-squamous non-small cell lung cancer. The study aims to find out which schedule is more effective in activating the immune system and fighting cancer.

Patient Parameters

Program Overview

This study is exploring two different ways to combine chemotherapy and immunotherapy for treating advanced non-squamous non-small cell lung cancer. The trial will test if starting with chemotherapy or immunotherapy first makes a difference in how well the treatment works. Researchers will measure how the immune system responds and how the cancer is affected. The goal is to see if staggering the treatments can improve patient outcomes.

Description

In this trial, researchers are testing two different schedules for giving chemotherapy and immunotherapy together to patients with advanced non-squamous non-small cell lung cancer. In one group, patients will receive chemotherapy first, followed by immunotherapy a week later. In the other group, patients will receive immunotherapy first, followed by chemotherapy a week later. This staggered approach allows researchers to see how each treatment contributes to fighting the cancer. The study will also look at how the body responds to the treatments and any factors that might affect the results. The hope is that this approach will lead to better outcomes for patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have confirmed lung cancer that is non-squamous and has spread.
  • Weigh more than 30 kg (about 66 pounds).
  • Have cancer that can be measured by scans.
  • Have not received chemoimmunotherapy before.
  • Be in good general health with a performance status of 0 to 2.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate blood cell counts and organ function.
  • Women must not be pregnant and must use effective birth control during the study and for 3 months after.
  • Must be willing to follow the study procedures and attend all visits.
  • Must be able to give informed consent.

Exclusion Criteria

  • Have a specific type of lung cancer with ALK or EGFR mutations.
  • Have had radiation therapy within 2 weeks before starting the study, except for certain cases.
  • Have had major surgery within 28 days before starting the study.
  • Have a history of organ transplantation.
  • Have active autoimmune or inflammatory disorders, with some exceptions.
  • Have used immunosuppressive medication within 14 days before starting the study, with some exceptions.
  • Have a history of primary immunodeficiency.
  • Have another cancer diagnosis within 2 years, with some exceptions.
  • Have uncontrolled brain metastases.
  • Have a history of leptomeningeal carcinomatosis.
  • Have uncontrolled illnesses that could interfere with the study.
  • Have an uncontrolled HIV infection.
  • Have active infections like tuberculosis, hepatitis B, or hepatitis C.
  • Have received a live vaccine within 30 days before starting the study.
  • Be pregnant or breastfeeding, or not willing to use birth control.
  • Have severe allergies to the study drugs or their components.
  • Be taking medications that are not allowed during the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.