OncoMatch/Clinical Trials/NCT04105270
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
Is NCT04105270 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Oral Restorative Microbiota Therapy (RMT) Capsules and Durvalumab 1500 mg IV for adenocarcinoma of lung.
Treatment: Oral Restorative Microbiota Therapy (RMT) Capsules · Durvalumab 1500 mg IV · Cisplatin/pemetrexed or Carboplatin/pemetrexed — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
does not have an EGFR sensitizing (activating) mutation
Required: ALK wild-type
does not have...ALK...translocation
Required: ROS1 wild-type
does not have...ROS1 translocation
Required: PD-L1 (CD274) expression (known PD-L1 TC expression status assayed by Ventana SP263 or PharmDx 22C3)
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.
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for advanced/metastatic NSCLC
Exception: adjuvant therapy for lung cancer permitted if >6 months from last dose at enrollment
Prior systemic therapy for advanced/metastatic NSCLC makes the patient ineligible for this study. 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.
Cannot have received: immunotherapy or investigational drug
Exception: adjuvant therapy for NSCLC permitted if >6 months since last treatment
Receipt of any immunotherapy or investigational drug within 4 weeks prior to the first dose of study drug; and in the case of monoclonal antibodies 6 weeks prior to the first dose of study drug. Prior treatment with any other anti-PD-1, or PD-L1, including durvalumab or an anti-PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors except as adjuvant therapy for NSCLC so long as it has been greater than six months since the last treatment
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥1,500/mcL; Platelets ≥ 100,000/mcL
Kidney function
Measured or calculated creatinine clearance >40 mL/min
Liver function
Total bilirubin ≤1.5x ULN (not applicable to confirmed Gilbert's syndrome); AST (SGOT) and ALT (SGPT) ≤2.5 x ULN unless liver metastases present, then ≤5x ULN
Adequate organ function within 14 days of study enrollment defined as: Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥1,500/mcL; Platelets ≥ 100,000/mcL; Total bilirubin ≤1.5x ULN (not applicable to confirmed Gilbert's syndrome); AST (SGOT) and ALT (SGPT) ≤2.5 x ULN unless liver metastases present, then ≤5x ULN; Measured or calculated creatinine clearance >40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dr. Amit Kulkarni · Phoenix, Arizona
- MNCCTN Essentia Health St. Joseph's Brainerd Medical Center · Brainerd, Minnesota
- MNCCTN Essentia Health Deer River · Deer River, Minnesota
- MNCCTN Essentia Health St. Mary's Detroit Lakes Clinic · Detroit Lakes, Minnesota
- MNCCTN Essentia Health Duluth · Duluth, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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