Study on RMT with Durvalumab and Chemotherapy for Untreated Adenocarcinoma Non-Small Cell Lung Cancer

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04105270

Provider View

This clinical trial is testing a new treatment that combines oral restorative microbiota therapy (RMT) with the drug durvalumab and chemotherapy for patients with advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC) who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of combining oral restorative microbiota therapy (RMT) with the drug durvalumab and chemotherapy in patients with advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC) who have not been treated before. The trial is designed to compare this combination treatment to a placebo in a double-blind, randomized setting, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC) that cannot be surgically removed and does not have certain genetic mutations.
  • Have measurable cancer based on specific medical criteria.
  • Provide a tumor sample for analysis.
  • May have had prior chemotherapy or immunotherapy for lung cancer if it was more than 6 months ago.
  • Treated brain metastases are allowed if stable and not requiring high doses of steroids.
  • Good overall health with a performance status of 0 or 1.
  • Weigh more than 30 kg.
  • Have adequate organ function based on blood tests.
  • Expected to live at least 12 more weeks.
  • Agree to use effective birth control during the study and for 3 months after the last dose.
  • Provide written consent to participate.

Exclusion Criteria

  • Not pregnant or breastfeeding, with a negative pregnancy test for women of childbearing potential.
  • Cannot swallow medications.
  • Have a different type of lung cancer or mixed tumors.
  • Have untreated brain metastasis or active cancer in the brain lining.
  • Allergic to any study drugs.
  • Received immunotherapy or investigational drugs recently.
  • Previously treated with certain immune drugs unless it was more than 6 months ago.
  • Using immunosuppressive medication recently, except for low-dose steroids.
  • Had major surgery recently.
  • Have active autoimmune diseases requiring treatment.
  • Have inflammatory bowel disease needing immunosuppression.
  • Have a history of immune deficiency or organ transplant.
  • Taking daily probiotics recently.
  • Have HIV with certain conditions.
  • Have active Hepatitis B or C.
  • Have uncontrolled illnesses or recent heart issues.
  • Have lung diseases requiring steroids.
  • Have psychiatric or social issues affecting study participation.
  • Have active tuberculosis or are on long-term antibiotics.
  • Received a live vaccine recently.
  • Have another cancer within the last 5 years, unless treated and disease-free.
  • Any condition that might interfere with the study.

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