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New treatment option for Adenocarcinoma of Lung
Official title RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
ClinicalTrials.gov ID: NCT04105270
What this study is testing
What is Oral Restorative Microbiota Therapy (RMT) Capsules?
Oral Restorative Microbiota Therapy (RMT) Capsules is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for adenocarcinoma of lung.
Also referred to as RMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed adenocarcinoma of the lung that is unresectable stage IIIB/C or stage IV, does not have an EGFR sensitizing...
- 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...
- 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...
You likely can't join if
- Not pregnant or breast feeding. Evidence of post-menopausal status, or negative urine or serum pregnancy test for female pre-menopausal patients...
- Dysphagia or inability to swallow medications
- Squamous cell, large cell, or NSCLC NOS (not otherwise specified) histology or mixed tumors
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- Provide voluntary written consent prior to the performance of any research related tests or procedures.
What rules you out
- 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...
- Dysphagia or inability to swallow medications
- Squamous cell, large cell, or NSCLC NOS (not otherwise specified) histology or mixed tumors
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Brainerd, Minnesota, United States
- Deer River, Minnesota, United States
- Detroit Lakes, Minnesota, United States
- Duluth, Minnesota, United States
- Fosston, Minnesota, United States
- Hibbing, Minnesota, United States
- Minneapolis, Minnesota, United States
- Sandstone, Minnesota, United States
- Virginia, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Brainerd, Minnesota, United States; Deer River, Minnesota, United States; Detroit Lakes, Minnesota, United States; Duluth, Minnesota, United States; Fosston, Minnesota, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.