Adenocarcinoma of LungPhase 2NCT04105270
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
A Phase 2 study testing Oral Restorative Microbiota Therapy (RMT) Capsules, Durvalumab 1500 mg IV and Cisplatin/pemetrexed or Carboplatin/pemetrexed in people with Adenocarcinoma of Lung and Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 10 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Lung, Lung Cancer
- What is being tested?
- Oral Restorative Microbiota Therapy (RMT) Capsules, Durvalumab 1500 mg IV and Cisplatin/pemetrexed or Carboplatin/pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Nov 2022to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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, 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.
Show all 19Show fewer
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
MNCCTN Essentia Health St. Joseph's Brainerd Medical Center
Brainerd, Minnesota, 56401
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
- Recruiting
MNCCTN Essentia Health Deer River
Deer River, Minnesota, 56636
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
- Recruiting
MNCCTN Essentia Health St. Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
- Recruiting
MNCCTN Essentia Health Duluth
Duluth, Minnesota, 55805
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
- Recruiting
MNCCTN Essentia Health Fosston
Fosston, Minnesota, 56542
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
- Recruiting
MNCCTN Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
- Recruiting
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
- Not yet recruiting
Dr. Amit Kulkarni
Phoenix, Arizona, 85338
Amit Kulkarni, (623) 220-5456
- Recruiting
MNCCTN Essentia Health Sandstone
Sandstone, Minnesota, 550723
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
- Recruiting
MNCCTN Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Tammie Mlodozynie, Tammie.Mlodozyniec@essentiahealth.org
About this study
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
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)
- Conditions
- Adenocarcinoma of Lung, Lung Cancer
- Being tested
- Oral Restorative Microbiota Therapy (RMT) Capsules, Durvalumab 1500 mg IV, Cisplatin/pemetrexed or Carboplatin/pemetrexed, Placebo
- Medical subject headings
- Adenocarcinoma of Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Restorative Microbiota Therapy (RMT) CapsulesDrug
Also called RMT
Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly
Durvalumab 1500 mg IVDrug
Patients with PD-L1 TC expression receive durvalumab 1500 mg IV every 4 weeks (Q4W) until disease progression or for a maximum of two years from the 1st dose of durvalumab
Cisplatin/pemetrexed or Carboplatin/pemetrexedDrug
Patients with PD-L1 TC receive cisplatin/pemetrexed or carboplatin/pemetrexed given every 3 weeks (Q3W) for 4 cycles followed by pemetrexed maintenance given Q3W
PlaceboOther
Sixteen doses of oral placebo capsules given weekly
| Study group | Role | What they receive |
|---|---|---|
| Arm A (RMT) | Experimental | Not described Receives: Drug: Oral Restorative Microbiota Therapy (RMT) Capsules; Drug: Durvalumab 1500 mg IV; Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed |
| Arm B (Placebo) | Experimental | Not described Receives: Drug: Durvalumab 1500 mg IV; Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed; Other: Placebo |
| Safety Run-in | Experimental | 10 patients are enrolled in this safety run-in arm. Patients are directly assigned to RMT treatment arm. After safety- run-in period of 4 weeks after the first dose of RMT, in the 10 patients if no new safety signal are seen enrollment moves to randomization Receives: Drug: Oral Restorative Microbiota Therapy (RMT) Capsules; Drug: Durvalumab 1500 mg IV; Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing Progression Free Survival (PFS)
Incidence of PFS using RECIST 1.1 in each treatment arm to evaluate the efficacy of restorative microbiota therapy
Measured: 3 Years
Safety and tolerability of RMT
Safety and tolerability of RMT in combination with durvalumab or durvalumab + chemotherapy as assessed by the incidence of adverse events
Measured: 2 Years
Secondary outcomes (7)
Objective Response Rate (ORR) RECIST 1.1
ORR of treatment with RMT in each treatment arm per RECIST 1.1
Measured: 2 Years
Duration of Response (DOR)
DOR of treatment with RMT in each treatment arm per RECIST 1.1
Measured: 2 Years
Overall Survival (OS)
Incidence of OS using RECIST 1.1 in each treatment arm
Measured: 3 Years
Immune mediated Adverse Events imAE
Rate of immune mediated adverse events (imAE) in each treatment arm
Measured: 2 Years
Objective Response Rate (ORR) (iRECIST)
ORR using immune response evaluation criteria in solid tumors (iRECIST)
Measured: 2 Years
Health-related quality of life (QoL)
Difference in health-related quality of life (QoL) using European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-30)
Measured: 2 Years
Health-related quality of life (QoL)
Difference in health-related quality of life (QoL) using lung cancer module (LC-13)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start30 Nov 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of LungStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Patel, DO, Principal investigator, University of Minnesota, Division of Hematology, Oncology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105270
- Sponsor's protocol ID
- 2019LS010
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2019
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04105270
- Acronym / sponsor ID
- 2019LS010
- Conditions
- Adenocarcinoma of Lung, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (RMT) | Experimental | Drug: Oral Restorative Microbiota Therapy (RMT) Capsules, Drug: Durvalumab 1500 mg IV, Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed |
| Arm B (Placebo) | Experimental | Drug: Durvalumab 1500 mg IV, Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed, Other: Placebo |
| Safety Run-in | Experimental | Drug: Oral Restorative Microbiota Therapy (RMT) Capsules, Drug: Durvalumab 1500 mg IV, Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed10 patients are enrolled in this safety run-in arm. Patients are directly assigned to RMT treatment arm. After safety- run-in period of 4 weeks after the first dose of RMT, in the 10 patients if no new safety signal are seen enrollment moves to randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Restorative Microbiota Therapy (RMT) CapsulesAlso: RMTPatients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly | Drug | Arm A (RMT), Safety Run-in |
| Durvalumab 1500 mg IVPatients with PD-L1 TC expression receive durvalumab 1500 mg IV every 4 weeks (Q4W) until disease progression or for a maximum of two years from the 1st dose of durvalumab | Drug | Arm A (RMT), Arm B (Placebo), Safety Run-in |
| Cisplatin/pemetrexed or Carboplatin/pemetrexedPatients with PD-L1 TC receive cisplatin/pemetrexed or carboplatin/pemetrexed given every 3 weeks (Q3W) for 4 cycles followed by pemetrexed maintenance given Q3W | Drug | Arm A (RMT), Arm B (Placebo), Safety Run-in |
| PlaceboSixteen doses of oral placebo capsules given weekly | Other | Arm B (Placebo) |
Primary outcome
Number of patients experiencing Progression Free Survival (PFS)
Time frame: 3 Years
Incidence of PFS using RECIST 1.1 in each treatment arm to evaluate the efficacy of restorative microbiota therapy
Safety and tolerability of RMT
Time frame: 2 Years
Safety and tolerability of RMT in combination with durvalumab or durvalumab + chemotherapy as assessed by the incidence of adverse events
7 secondary outcomes
Objective Response Rate (ORR) RECIST 1.1
Time frame: 2 Years
Duration of Response (DOR)
Time frame: 2 Years
Overall Survival (OS)
Time frame: 3 Years
Immune mediated Adverse Events imAE
Time frame: 2 Years
Objective Response Rate (ORR) (iRECIST)
Time frame: 2 Years
Health-related quality of life (QoL)
Time frame: 2 Years
Health-related quality of life (QoL)
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manish Patel, DO principal investigator
University of Minnesota, Division of Hematology, Oncology and Transplantation
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Restorative Microbiota Therapy (RMT) Capsules, Durvalumab 1500 mg IV and Cisplatin/pemetrexed or Carboplatin/pemetrexed in people with Adenocarcinoma of Lung and Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Center Clinical Trials Office (612 624 2620, ccinfo@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing Progression Free Survival (PFS) (time frame: 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.