RMT + Immunotherapy + Chemotherapy for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of 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)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on daily probiotics or chronic systemic antibiotics. It's best to discuss your specific medications with the trial team.
Is the combination of pemetrexed and cisplatin safe for humans?
Pemetrexed combined with cisplatin has been approved for use in certain cancers and is generally considered safe when patients receive vitamin supplements to reduce side effects. Common side effects include low blood cell counts, fatigue, and nausea, but these can be managed with proper medical care.12345
What makes the RMT + Immunotherapy + Chemotherapy treatment for lung cancer unique?
What data supports the effectiveness of the drug combination of Cisplatin/pemetrexed or Carboplatin/pemetrexed for lung cancer?
Who Is on the Research Team?
Manish Patel, DO
Principal Investigator
University of Minnesota, Division of Hematology, Oncology and Transplantation
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic lung adenocarcinoma that can't be surgically removed and doesn't have certain genetic mutations. They must weigh over 30 kg, have a performance status of 0 or 1, agree to use contraception if applicable, and not have had recent major surgery or other treatments that might interfere. Those with stable treated brain metastases may qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
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, if no new safety signals are seen, enrollment moves to randomization.
Treatment
Participants receive oral restorative microbiota therapy (RMT) or placebo combined with intravenous (IV) durvalumab plus chemotherapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin/pemetrexed or Carboplatin/pemetrexed
- Durvalumab 1500 mg IV
- Oral Restorative Microbiota Therapy (RMT) Capsules
Cisplatin/pemetrexed or Carboplatin/pemetrexed is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Masonic Cancer Center, University of Minnesota
Lead Sponsor