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

StatusRecruiting
PhasePhase 2
Started2022-11-30
View on ClinicalTrials.gov ↗

Amendment history

2025-09-10
Study Status, Contacts/Locations v17
Study sites9→10
2025-06-10
Study Status, Contacts/Locations v16
Study sites1→9
2025-06-09
3 amendments v13-v15
3 re-verifications since 2023-12-15, no change to tracked fields
2022-12-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v12
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-11→confirmed 2022-11-30
Study sitesdetails revised at 1 of 1 site
2022-11-02
Study Status v11
Start date2022-06→2022-11
Show 10 earlier versions
2022-04-04
Study Status v10
Start date2022-02→2022-06
2021-11-04
Study Status v9
Start date2021-09→2022-02
2021-08-03
Study Identification, Study Status, Study Design, Arms and Interventions v8
Start date2021-07→2021-09
Enrollment target30→82
Study arms2→3
Study title+36 characters
P2 of RMT in ComboCombination wWith Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
2021-07-19
Study Status, Arms and Interventions v7
InterventionsA: Durvalumab 1500 mg IV (Drug), A: Oral Restorative Microbiota Therapy (RMT) Capsules (Drug), B: Cisplatin/pemetrexed or…→Cisplatin/pemetrexed or Carboplatin/pemetrexed (Drug), Durvalumab 1500 mg IV (Drug), Oral Restorative Microbiota Therapy (RMT) Capsules…
2021-07-06
Study Identification, Study Status, Oversight, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v6
Start date2021-05→2021-07
Study sites0→1
Eligibility criteria-543 characters
[...] nsitizing (activating) mutation or ALK or ROS1 translocation. BRAF, RET, NTRK, MET ex 14 splice site mutation Measurable disease based on RECIST 1.1 Body weight of >30kg 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 surge [...] Tumor sample requirements Mandatory provision of an unstaine [...] hival tissue will be used to assay with Ventana SP263 test. EvidencePrior chemotherapy or i [...] [...]
Secondary endpoints8 to 7 entries
ProgressionObjective FreeResponse SurvivalRate (PFSORR) (RECIST 1.1) Progression Free Survival (PFS) (iRECIST)
Primary endpoints2 entries, revised
ObjectiveNumber Responseof Ratepatients experiencing Progression Free Survival (ORR) (RECIST 1.1PFS) Safety and Tolerabilitytolerability of RMT
2021-02-09
Study Status v5
Start date2021-01→2021-05
2021-01-20
Study Status v4
Start date2020-12→2021-01
2020-08-18
Study Status v3
Start date2020-07→2020-12
2020-04-09
Study Status v2
Start date2020-03→2020-07
2020-01-14
Study Status v1
Primary completion date2024-03→2028-01
Completion date2024-03→2028-01
Start date2019-12→2020-03
2019-09-24
Original filing
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)
Trial Details
NCT Number NCT04105270
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Adenocarcinoma of Lung, Lung Cancer
Enrollment 82 participants
Start Date 2022-11-30
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-17