P2 of RMT in Combo w Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC

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Brief Title

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

Official Title

A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) in Combination With Durvalumab (MEDI4736) and Chemotherapy in Untreated Patients With Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

Brief Summary

      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)

Study Phase

Phase 2

Study Type


Primary Outcome

Number of patients experiencing Progression Free Survival (PFS)

Secondary Outcome

 Objective Response Rate (ORR) RECIST 1.1


Adenocarcinoma of Lung


Oral Restorative Microbiota Therapy (RMT) Capsules

Study Arms / Comparison Groups

 Arm A (RMT)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 2022

Completion Date

January 2028

Primary Completion Date

January 2028

Eligibility Criteria

        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 lesions, for palliative intent is
             acceptable (e.g. by local surgery or radiotherapy). Prior systemic therapy for
             advanced/metastatic NSCLC makes the patient ineligible for this study.

          -  Patients with treated brain metastasis are eligible as long as they have stable
             symptoms, are more than 2 weeks from completion of therapy, and do not require more
             than 10mg of daily prednisone or equivalent.

          -  ECOG Performance status of 0 or 1

          -  Body weight of >30 kg

          -  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 upper limit of normal (ULN) - this will not apply to
                  patients with confirmed Gilbert's syndrome (persistent or recurrent
                  hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis
                  or hepatic pathology), who will be allowed only in consultation with their

               -  AST (SGOT) and ALT (SGPT) ≤2.5 x institutional ULN unless liver metastases are
                  present, in which case it must be ≤5x ULN

               -  Measured creatinine clearance (CL) >40 mL/min or calculated creatinine CL>40
                  mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour
                  urine collection for determination of creatinine clearance:

          -  Expected life expectancy of at least 12 weeks in the opinion of the enrolling
             investigator as documented in the medical record

          -  Women of childbearing potential and men with partners of child-bearing potential must
             agree to use effective contraception for the time of screening to the duration of
             treatment and 3 months after the last dose of study drug

          -  Provide voluntary written consent prior to the performance of any research related
             tests or procedures.

        Exclusion Criteria:

          -  Not pregnant or breast feeding. Evidence of post-menopausal status, or negative urine
             or serum pregnancy test for female pre-menopausal patients. Women will be considered
             postmenopausal if they have amenorrhea for 12 months without an alternative medical

          -  Dysphagia or inability to swallow medications

          -  Squamous cell, large cell, or NSCLC NOS (not otherwise specified) histology or mixed

          -  Has untreated brain metastasis or active leptomeningeal carcinomatosis

          -  Has a known sensitivity to any component of therapeutic agents used in this study

          -  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

          -  Current or prior use of immunosuppressive medication within 28 days before the first
             dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or
             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of
             prednisone, or an equivalent corticosteroid

          -  Recent major surgery within 4 weeks prior to entry into the study (excluding the
             placement of vascular access) that would prevent administration of study drug

          -  Active or prior documented autoimmune disease within the past 2 years requiring
             systemic treatment (i.e. with use of disease modifying agents, corticosteroids or
             immunosuppressive drugs). Patients with vitiligo, Grave's disease, or psoriasis not
             requiring systemic treatment (within the past 2 years) are not excluded. Replacement
             therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy
             for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic

          -  Active documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
             who require immunosuppression or patients who exceed 10 mg/day of prednisone, or an
             equivalent corticosteroid are excluded

          -  History of primary immunodeficiency

          -  History of organ transplant that requires therapeutic immunosuppression

          -  Taking daily probiotics (patients with last probiotic > 4weeks prior to first dose of
             RMT are eligible)

          -  History of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive) who
             are on anti-retroviral treatment for < 6 months and absolute CD4 count<500 (patients
             with HIV not meeting these criteria are eligible)

          -  Has known active Hepatitis B or C. Active Hepatitis B is defined as a known positive
             HBsAg, and positive hepatitis B virus quantification assay (patients with history of
             Hepatitis B who have seroconversion i.e. Hepatitis B core antibody positive and
             Hepatitis B surface antibody positive are eligible). Active Hepatitis C is defined by
             a known positive Hep C Ab result and positive quantitative HCV RNA results (Patients
             with Hepatitis C who are on anti-viral suppressive therapy and negative quantitative
             HCV RNA results are eligible)

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active
             bleeding diatheses

          -  Myocardial infarction or stroke within 3 months prior to enrollment

          -  History of systolic or diastolic heart failure with New York Heart Association (NYHA)
             class III or IV symptoms (refer to Appendix II)

          -  Has active or prior history of (non-infectious) pneumonitis that required steroids or
             patients with interstitial lung disease

          -  Psychiatric illness/social situations that would limit compliance with study
             requirements or compromise the ability of the patient to give written informed consent

          -  Known history of active tuberculosis. Patients with prior history of latent TB could
             be included if they have been treated previously with isoniazid.

          -  Patients who are on chronic systemic antibiotic therapy (antibiotics for ≥60
             consecutive days within 12 weeks of enrollment). Patients who receive systemic
             antibiotics between enrollment and start of RMT are eligible

          -  Receipt of live attenuated vaccination within 30 days prior to study entry or within
             30 days of receiving RMT

          -  History of another primary malignancy (excluding non-melanoma skin cancer) within 5
             years prior to starting RMT, except if the patient has undergone potentially curative
             therapy with no evidence of disease recurrence for 5 years since initiation of that

          -  Any condition that, in the opinion of the investigator, would interfere with
             evaluation of the study drug or interpretation of patient safety or study results




18 Years - N/A

Accepts Healthy Volunteers



Amit Kulkarni, MBBS, 612 624 2620, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Masonic Cancer Center, University of Minnesota

Study Sponsor

Amit Kulkarni, MBBS, Principal Investigator, University of Minnesota, Division of Hematology, Oncology and Transplantation

Verification Date

November 2022