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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT04105270
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral Restorative Microbiota Therapy (RMT) Capsules — DRUG
    Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly
  • Durvalumab 1500 mg IV — DRUG
    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
  • Cisplatin/pemetrexed or Carboplatin/pemetrexed — DRUG
    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
  • Placebo — OTHER
    Sixteen doses of oral placebo capsules given weekly

Study Details

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)

Key Dates

Start date
Nov 30, 2022
Status verified
Sep 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (RMT)
  • Experimental: Arm B (Placebo)
  • Experimental: Safety Run-in
    10 patients are enrolled in this safety run-in arm. Patients are directly assigned to RMT treatment arm. After safety- run-in period of 4 weeks after the first dose of RMT, in the 10 patients if no new safety signal are seen enrollment moves to randomization

Primary Outcome Measure

Number of patients experiencing Progression Free Survival (PFS) [ Time Frame: 3 Years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Dr. Amit KulkarniPhoenixArizona85338
Amit Kulkarni
623-220-5456
MNCCTN Essentia Health St. Joseph's Brainerd Medical CenterBrainerdMinnesota56401
Tammie Mlodozynie
[email protected]
MNCCTN Essentia Health Deer RiverDeer RiverMinnesota56636
Tammie Mlodozynie
[email protected]
MNCCTN Essentia Health St. Mary's Detroit Lakes ClinicDetroit LakesMinnesota56501
Tammie Mlodozynie
[email protected]
MNCCTN Essentia Health DuluthDuluthMinnesota55805
Tammie Mlodozynie
[email protected]
MNCCTN Essentia Health FosstonFosstonMinnesota56542
Tammie Mlodozynie
[email protected]
MNCCTN Essentia Health Hibbing ClinicHibbingMinnesota55746
Tammie Mlodozynie
[email protected]
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-
MNCCTN Essentia Health SandstoneSandstoneMinnesota550723
Tammie Mlodozynie
[email protected]
MNCCTN Essentia Health Virginia ClinicVirginiaMinnesota55792
Tammie Mlodozynie
[email protected]

Find similar trials in Phoenix, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Dr. Amit Kulkarni· Phoenix, AZMNCCTN Essentia Health St. Joseph's Brainerd Medical Center· Brainerd, MNMNCCTN Essentia Health Deer River· Deer River, MNMNCCTN Essentia Health St. Mary's Detroit Lakes Clinic· Detroit Lakes, MNMNCCTN Essentia Health Duluth· Duluth, MNMNCCTN Essentia Health Fosston· Fosston, MN

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