Actively Recruiting
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-09-11
82
Participants Needed
10
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with confirmed unresectable stage IIIB/C or stage IV adenocarcinoma of the lung without certain genetic mutations
- Measurable disease according to RECIST 1.1 criteria
- Must provide sufficient tumor tissue sample for biomarker and genomic analysis
- Known PD-L1 tumor cell expression status
- Prior adjuvant chemotherapy or immunotherapy allowed if completed more than 6 months ago
- Patients with treated, stable brain metastasis eligible if symptoms are stable and steroid use is limited
- ECOG performance status of 0 or 1
- Body weight greater than 30 kg
- Adequate organ function within 14 days before enrollment as defined by specific blood and kidney function tests
- Expected life expectancy of at least 12 weeks
- Women and men of childbearing potential must agree to use effective contraception during and 3 months after treatment
- Provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women; women of childbearing potential must have a negative pregnancy test
- Difficulty swallowing medications
- Histology other than adenocarcinoma, including squamous cell, large cell, or mixed tumors
- Untreated brain metastases or active leptomeningeal carcinomatosis
- Known allergies to study treatments
- Recent immunotherapy or investigational drug use within 4 to 6 weeks prior to study start
- Prior treatment with PD-1/PD-L1 inhibitors except certain adjuvant therapy
- Use of immunosuppressive medications within 28 days prior to study except specific low-dose corticosteroids
- Recent major surgery within 4 weeks that prevents study drug administration
- Active or recent autoimmune diseases requiring systemic therapy
- Active inflammatory bowel disease requiring immunosuppression
- History of primary immunodeficiency or organ transplant requiring immunosuppression
- Current daily probiotic use within 4 weeks prior to study drug
- Active HIV infection with low CD4 counts or recent antiretroviral treatment
- Active Hepatitis B or C infections as defined by specific tests
- Uncontrolled illnesses such as infections, heart conditions, or bleeding disorders
- Recent heart attack or stroke within 3 months
- Severe heart failure (NYHA class III or IV)
- History of steroid-requiring pneumonitis or interstitial lung disease
- Psychiatric or social conditions limiting study compliance
- Active tuberculosis
- Chronic systemic antibiotic use within 12 weeks
- Recent live vaccinations within 30 days
- History of other primary cancers within 5 years except certain skin cancers
- Any other condition interfering with study evaluation or safety interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Dr. Amit Kulkarni
Phoenix, Arizona, United States, 85338
Not Yet Recruiting
2
MNCCTN Essentia Health St. Joseph's Brainerd Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
3
MNCCTN Essentia Health Deer River
Deer River, Minnesota, United States, 56636
Actively Recruiting
4
MNCCTN Essentia Health St. Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States, 56501
Actively Recruiting
5
MNCCTN Essentia Health Duluth
Duluth, Minnesota, United States, 55805
Actively Recruiting
6
MNCCTN Essentia Health Fosston
Fosston, Minnesota, United States, 56542
Actively Recruiting
7
MNCCTN Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
8
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
9
MNCCTN Essentia Health Sandstone
Sandstone, Minnesota, United States, 550723
Actively Recruiting
10
MNCCTN Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
Research Team
C
Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here