NCT04105270 · Masonic Cancer Center, University of Minnesota
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
What this study is about
This is a randomly assigned, active-controlled, parallel-group, where neither patients nor doctors know which treatment is given Phase II trial, of taken by mouth restorative microbiota therapy (RMT) or placebo combined with given through a vein (IV) (IV) durvalumab (MEDI4736) plus chemotherapy in patients with treatment naïve advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC)
View original scientific description
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)
Interventions
DRUG
Oral Restorative Microbiota Therapy (RMT) Capsules
Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly
DRUG
Durvalumab 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
DRUG
Cisplatin/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
OTHER
Placebo
Sixteen doses of oral placebo capsules given weekly
Primary outcome measures
Number of patients experiencing Progression Free Survival (PFS)
Time frame: 3 Years
Incidence of PFS using RECIST 1.1 in each treatment arm to evaluate the efficacy of restorative microbiota therapy
Safety and tolerability of RMT
Time frame: 2 Years
Safety and tolerability of RMT in combination with durvalumab or durvalumab + chemotherapy as assessed by the incidence of adverse events
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the lung that is unresectable stage IIIB/C or stage IV, does not have an EGFR sensitizing (activating) mutation or ALK or ROS1 translocation. BRAF, RET, NTRK, MET ex 14 splice site mutation
- Measurable disease based on RECIST 1.1
- Tumor sample requirements
- Mandatory provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for biomarker and genomic analysis. A minimum of 10 unstained slides should be available for evaluation.
- Known PD-L1 TC expression status assayed by Ventana SP263. Patients who have known PDL-1 as assayed by PharmDx 22C3 assay may be eligible; however, available archival tissue will be used to assay with Ventana SP263 test.
- Prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been \>6 months from last dose at the time of enrollment. Local treatment of isolated lesions, excluding target lesion
Where
- Phoenix, Arizona
- Brainerd, Minnesota
- Deer River, Minnesota
- Detroit Lakes, Minnesota
- Duluth, Minnesota
- Fosston, Minnesota
- Hibbing, Minnesota
- Minneapolis, Minnesota
- Sandstone, Minnesota
- Virginia, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2025 · Source of record for eligibility and locations