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Chemotherapy
RMT + Immunotherapy + Chemotherapy for Lung Cancer
Phase 2
Recruiting
Led By Amit Kulkarni, MBBS
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Body weight of >30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new therapy for lung cancer that combines a microbiota drug with chemotherapy and an immunotherapy drug.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests oral RMT capsules versus placebo combined with IV Durvalumab and chemo (Cisplatin/Pemetrexed or Carboplatin/Pemetrexed). It's a Phase II trial where patients are randomly assigned to either the RMT group or the placebo group while receiving standard cancer treatment.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy reactions like nausea, fatigue, hair loss; Durvalumab may cause immune-related issues such as inflammation in organs, skin problems, hormonal changes; RMT's risks are less known but could involve digestive discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced, cannot be surgically removed, and lacks certain genetic changes.
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My body weight is over 30 kg.
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I am fully active or can carry out light work.
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My organs are functioning well enough for me to join the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients experiencing Progression Free Survival (PFS)
Safety and tolerability of RMT
Secondary outcome measures
Duration of Response (DOR)
Health-related quality of life (QoL)
Immune mediated Adverse Events imAE
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Safety Run-inExperimental Treatment3 Interventions
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
Group II: Arm B (Placebo)Experimental Treatment3 Interventions
Group III: Arm A (RMT)Experimental Treatment3 Interventions
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,571 Total Patients Enrolled
Amit Kulkarni, MBBSPrincipal InvestigatorUniversity of Minnesota, Division of Hematology, Oncology and Transplantation
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or stroke in the last 3 months.I have had lung inflammation or lung disease that needed steroids.I haven't taken strong immune system suppressing drugs in the last 28 days.I have had an autoimmune disease in the last 2 years that needed treatment.I do not have any uncontrolled illnesses like heart problems, high blood pressure, or active infections.I have brain metastasis or leptomeningeal disease that hasn't been treated.My lung cancer is of a specific type (squamous, large cell, or not specified).I have not received a live vaccine within the last 30 days.My lung cancer is advanced, cannot be surgically removed, and lacks certain genetic changes.I haven't had certain immune therapies for my cancer, except as previous lung cancer treatment over 6 months ago.My body weight is over 30 kg.I have severe heart failure symptoms.You have a disease that can be measured using specific guidelines called RECIST 1.1.I have HIV, been on treatment for less than 6 months, and my CD4 count is below 500.You are not pregnant or breastfeeding. If you are a pre-menopausal woman, you need to have a negative pregnancy test or show evidence of not having periods for 12 months without a medical reason.I can provide at least 10 slides of my tumor for testing.I haven't taken any immunotherapy or experimental drugs in the last 4 weeks.I have been cancer-free for 5 years from a previous cancer, except for non-melanoma skin cancer.I had chemotherapy or immunotherapy for lung cancer more than 6 months ago.My cancer's PD-L1 status has been tested.I do not have active inflammatory bowel disease requiring strong medication.I have had an organ transplant and take medication to suppress my immune system.I haven't had major surgery in the last 4 weeks that would interfere with taking the study drug.I have trouble swallowing or can't swallow pills.I have an active case of tuberculosis.I have been on antibiotics for more than 60 days in the last 3 months.You have a history of a weakened immune system from birth.I haven't taken probiotics in the last 4 weeks.You currently have active Hepatitis B or C.I am fully active or can carry out light work.I agree to use effective birth control during and for 3 months after the study.My organs are functioning well enough for me to join the study.My brain metastasis is treated, stable for over 2 weeks, and I take 10mg or less of prednisone daily.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-in
- Group 2: Arm A (RMT)
- Group 3: Arm B (Placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other existing studies that have used Oral Restorative Microbiota Therapy (RMT) Capsules?
"Currently, there are 1471 ongoing clinical trials researching Oral Restorative Microbiota Therapy (RMT) Capsules. Of those trials, 430 are in Phase 3. While several of the clinical trials for Oral Restorative Microbiota Therapy (RMT) Capsules are located in Shanghai, China, there are 75077 locations operating trials for Oral Restorative Microbiota Therapy (RMT) Capsules globally."
Answered by AI
What are the goals that this clinical trial is hoping to achieve?
"The primary metric that will be used to gauge the success of this clinical trial, which is expected to last for 2 years, is Progression Free Survival (PFS). Additionally, Objective Response Rate (ORR) RECIST 1.1, Duration of Response (DOR), and Overall Survival (OS) will all be monitored as secondary outcomes."
Answered by AI
What are Oral Restorative Microbiota Therapy (RMT) Capsules most frequently employed to help with?
"Oral Restorative Microbiota Therapy (RMT) Capsules can be used as an initial treatment, or to help patients with advanced thymoma and advanced testicular cancer."
Answered by AI
Does the FDA condone the use of Oral Restorative Microbiota Therapy (RMT) Capsules?
"Since this is a Phase 2 trial, there is only preliminary data supporting the safety of Oral Restorative Microbiota Therapy (RMT) Capsules. No efficacy has been observed thus far."
Answered by AI
Are patients being actively recruited for this research project?
"Unfortunately, this particular trial is not presently recruiting patients as of November 2nd, 2022. Although this study's status could change in the future, there are many other clinical trials (3907 to be exact) that are actively looking for participants right now."
Answered by AI
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