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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
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 →Frequently asked questions
Is NCT04105270 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify