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

ConditionsAdenocarcinoma of LungLung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral Restorative Microbiota Therapy (RMT) Capsules

    Drug

    Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly

  • Durvalumab 1500 mg IV

    Drug

    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/pemetrexed

    Drug

    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

  • Placebo

    Other intervention

    Sixteen doses of oral placebo capsules given weekly

Treatment groups

82 Participants
are divided into 3 treatment groups
Group A: Arm A (RMT)Experimental treatment 3 interventions
Group B: Arm B (Placebo)Experimental treatment 3 interventions
Group C: Safety Run-inExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 Years
2

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

Time frame
2 Years

Secondary outcomes

1

Objective Response Rate (ORR) RECIST 1.1

ORR of treatment with RMT in each treatment arm per RECIST 1.1

Time frame
2 Years
2

Duration of Response (DOR)

DOR of treatment with RMT in each treatment arm per RECIST 1.1

Time frame
2 Years
3

Overall Survival (OS)

Incidence of OS using RECIST 1.1 in each treatment arm

Time frame
3 Years
4

Immune mediated Adverse Events imAE

Rate of immune mediated adverse events (imAE) in each treatment arm

Time frame
2 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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