RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests oral restorative microbiota therapy (RMT), a treatment involving microbes, against a placebo with no active treatment. Both groups also get durvalumab through a vein and chemotherapy. It is for people with advanced or spreading lung adenocarcinoma, a type of non-small cell lung cancer, who have not had drug treatment for advanced disease.
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have lung adenocarcinoma confirmed by a tissue or cell test, at stage IIIB/C that cannot be removed by surgery, or stage IV. The cancer must meet the study’s gene test rules.
- Have cancer that can be measured on scans, a stored tumor sample with at least 10 slides, and a known PD-L1 test result, which measures a protein on cancer cells.
- Have not had drug treatment for advanced or spreading lung cancer. Earlier chemotherapy or immune treatment given after main treatment is allowed if it ended more than 6 months ago.
- If cancer has spread to the brain, it must have been treated more than 2 weeks ago, symptoms must be stable, and prednisone needs must be no more than 10 mg daily or an equal dose of another steroid.
- Be fully active or able to do light work, and weigh more than 30 kg (about 66 pounds).
- Have blood counts and liver and kidney test results that meet study limits within 14 days before joining.
- Be expected by the study doctor to live at least 12 weeks and give written consent before study tests.
- If you or your partner could become pregnant, agree to use effective birth control from screening through treatment and for 3 months after the last study dose.
Who can't join
- Are pregnant or breastfeeding, cannot swallow medicines, or are allergic to any study treatment ingredient.
- Have another lung cancer type or a mixed tumor, untreated cancer in the brain, or active cancer in the lining around the brain and spinal cord.
- Have had certain recent immune treatments, study drugs, medicines that weaken the immune system, or major surgery that would prevent treatment. Some earlier immune treatments also rule out joining.
- Have certain immune system problems, an organ transplant needing immune-suppressing drugs, or an autoimmune disease needing whole-body treatment in the past 2 years. Autoimmune diseases make the immune system attack the body; some exceptions apply.
- Have bowel inflammation needing immune-suppressing treatment, certain lung inflammation or scarring, an uncontrolled illness, severe heart failure, or a heart attack or stroke in the past 3 months.
- Have active hepatitis B or C, active tuberculosis, or HIV with both less than 6 months of HIV treatment and a CD4 immune cell count below 500. Some treated infections are allowed.
- Take daily probiotics unless stopped more than 4 weeks before RMT, have used whole-body antibiotics for at least 60 days in a row within the past 12 weeks, or have had a live vaccine within the study’s 30-day limits.
- Have had another cancer within the past 5 years, with certain exceptions, or have a health or personal situation that could prevent consent, following study rules, or safe and clear study results.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 physician. * 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 explanation * 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 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 treatment. * 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 therapy * 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
Study sites (10)
AZ
- Dr. Amit Kulkarni · Phoenix, AZ 85338Amit Kulkarni · Study contact · (623) 220-5456More trials in Phoenix
MN
- MNCCTN Essentia Health St. Joseph's Brainerd Medical Center · Brainerd, MN 56401Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Brainerd
- MNCCTN Essentia Health Deer River · Deer River, MN 56636Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Deer River
- MNCCTN Essentia Health St. Mary's Detroit Lakes Clinic · Detroit Lakes, MN 56501Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Detroit Lakes
- MNCCTN Essentia Health Duluth · Duluth, MN 55805Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Duluth
- MNCCTN Essentia Health Fosston · Fosston, MN 56542Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Fosston
- MNCCTN Essentia Health Hibbing Clinic · Hibbing, MN 55746Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Hibbing
- Masonic Cancer Center, University of Minnesota · Minneapolis, MN 55455More trials in Minneapolis
- MNCCTN Essentia Health Sandstone · Sandstone, MN 550723Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Sandstone
- MNCCTN Essentia Health Virginia Clinic · Virginia, MN 55792Tammie Mlodozynie · Study contact · Tammie.Mlodozyniec@essentiahealth.orgMore trials in Virginia