RecruitingPhase 2NCT04105270

RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial

A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) in Combination With Durvalumab (MEDI4736) and Chemotherapy in Untreated Patients With Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

82 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, active-controlled, parallel-group, double-blind Phase II trial, of oral restorative microbiota therapy (RMT) or placebo combined with intravenous (IV) durvalumab (MEDI4736) plus chemotherapy in patients with treatment naïve advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a standard lung cancer immunotherapy drug (durvalumab) with chemotherapy and a new drug that activates the immune system (RMT) works better than the standard treatment alone for advanced non-small cell lung cancer (a type of lung cancer called adenocarcinoma). **You may be eligible if...** - You have been diagnosed with advanced or metastatic lung adenocarcinoma (stages IIIB/C or IV) - Your tumour does not have certain genetic changes (EGFR, ALK, ROS1, and some others) that would direct you to targeted therapies - You are reasonably active (ECOG 0 or 1) - You weigh more than 30 kg - Your organs are functioning adequately **You may NOT be eligible if...** - You have already received systemic treatment (chemotherapy or immunotherapy) for advanced/metastatic lung cancer - Your tumour has EGFR, ALK, or ROS1 mutations that have standard targeted therapies available - You have brain metastases that are unstable or require high-dose steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral Restorative Microbiota Therapy (RMT) Capsules

Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly

DRUGDurvalumab 1500 mg IV

Patients with PD-L1 TC expression receive durvalumab 1500 mg IV every 4 weeks (Q4W) until disease progression or for a maximum of two years from the 1st dose of durvalumab

DRUGCisplatin/pemetrexed or Carboplatin/pemetrexed

Patients with PD-L1 TC receive cisplatin/pemetrexed or carboplatin/pemetrexed given every 3 weeks (Q3W) for 4 cycles followed by pemetrexed maintenance given Q3W

OTHERPlacebo

Sixteen doses of oral placebo capsules given weekly


Locations(10)

Dr. Amit Kulkarni

Phoenix, Arizona, United States

MNCCTN Essentia Health St. Joseph's Brainerd Medical Center

Brainerd, Minnesota, United States

MNCCTN Essentia Health Deer River

Deer River, Minnesota, United States

MNCCTN Essentia Health St. Mary's Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States

MNCCTN Essentia Health Duluth

Duluth, Minnesota, United States

MNCCTN Essentia Health Fosston

Fosston, Minnesota, United States

MNCCTN Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

MNCCTN Essentia Health Sandstone

Sandstone, Minnesota, United States

MNCCTN Essentia Health Virginia Clinic

Virginia, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT04105270


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