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Tyrosine Kinase Inhibitor

MRX-2843 + Osimertinib for Lung Cancer

Phase 1
Recruiting
Led By Taofeek K Owonikoko, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The effects of MRX-2843 and osimertinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration
Females of childbearing potential who are sexually active with a non-sterilized male partner agree to use 2 methods of effective contraception from screening, and agree to continue using such precautions for 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to time of progression or death, whichever occurs first, assessed at 1 year
Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they are effective in treating patients with lung cancer that has spread to other parts of the body. The drugs may work by blocking enzymes needed for cell growth.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has an EGFR mutation. Participants must be able to swallow pills, have certain blood counts and liver function, and not be pregnant or breastfeeding. They should agree to use contraception if there's a risk of pregnancy. People can't join if they have heart problems, untreated brain metastases, certain infections like HIV, or are on drugs affecting liver enzymes.Check my eligibility
What is being tested?
The trial is testing the combination of MRX-2843 and Osimertinib to find the safest dose and study side effects in patients whose lung cancer has spread. These drugs may block enzymes needed for tumor growth. The trial includes different groups based on prior treatments received.See study design
What are the potential side effects?
Potential side effects include issues with heart rhythm (QTc prolongation), inflammation of lungs (pneumonitis), eye problems (keratitis), allergic reactions similar to past allergies from related compounds, increased infection risk due to immune suppression, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control during and up to 4 months after the study.
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I agree to use two forms of birth control during and for 90 days after the study if I can have children and am sexually active with a man.
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I can safely take pills by mouth.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My lung cancer has a specific EGFR mutation.
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I have not taken osimertinib or any EGFR TKI for my condition, or if I have, it was over a year ago without recurrence.
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My bilirubin levels are within the normal range, even with liver issues or Gilbert's disease.
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I am a man who can father children and will use birth control during and for 3 months after the study.
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I can take care of myself and am up and about more than half of the day.
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My hemoglobin level is at least 8.5 g/dL and I haven't had a blood transfusion in the last 2 weeks.
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My cancer progressed after treatment with specific EGFR inhibitors and I am not positive for EGFR-T790M mutation.
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I am eligible for the backfill cohort because I don't fit into other groups but meet the general requirements.
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My liver enzymes are within the required limits.
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I have a tumor that can be measured and is big enough according to specific guidelines.
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I am not pregnant and have negative pregnancy tests before treatment.
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I have NSCLC with worsening condition, previously treated or not with EGFR-TKI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to time of progression or death, whichever occurs first, assessed at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of progression or death, whichever occurs first, assessed at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Recommended phase 2 dose (RP2D) of the tested combination (dose escalation)
Secondary outcome measures
1-year progression free survival rate (dose expansion)
Overall response rate (ORR) (dose expansion)
Predictive Protein Biomarkers

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (osimertinib, MRX-2843)Experimental Treatment2 Interventions
Patients receive osimertinib PO QD and MRX-2843 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,633 Previous Clinical Trials
2,560,088 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,272 Total Patients Enrolled
Taofeek K Owonikoko, MD, PhDPrincipal InvestigatorEmory University

Media Library

MRX-2843 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04762199 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Treatment (osimertinib, MRX-2843)
Non-Small Cell Lung Cancer Clinical Trial 2023: MRX-2843 Highlights & Side Effects. Trial Name: NCT04762199 — Phase 1
MRX-2843 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04762199 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for patients to join this experiment?

"As indicated on the clinicaltrials.gov database, this trial is actively enrolling participants and was first introduced to the public on February 24th 2021 with its most recent update occuring on March 8th 2022."

Answered by AI

What evidence is there to support the efficacy of Flt3/MerTK Inhibitor MRX-2843?

"Currently, 101 investigations into Flt3/MerTK Inhibitor MRX-2843 are taking place with 17 trials in the final stage. Out of Uniondale, New york several studies on this subject matter have been initiated and a grand total of 4702 locations are running clinical trials for Flt3/MerTK Inhibitor MRX-2843."

Answered by AI

Is this a pioneering research project?

"Since 2013, research into Flt3/MerTK Inhibitor MRX-2843 has been ongoing. It was initially sponsored by AstraZeneca in a study involving 603 patients. Following the first trial, it received its Phase 1 & 2 drug approval and is now currently being studied across 1059 cities within 51 nations with 101 active trials."

Answered by AI

How many volunteers have participated in this experiment?

"Affirmative. The clinical trial is currently recruiting, as evidenced by the data hosted on clinicaltrials.gov from its inception date of February 24th 2021 and latest update on March 8th 2022. 69 volunteers are being sought across a single site for recruitment."

Answered by AI

Could you please expound on the risks of Flt3/MerTK Inhibitor MRX-2843?

"Assessing the safety of Flt3/MerTK Inhibitor MRX-2843 on a scale from 1 to 3, our team at Power have assigned it a score of 1 as this is still in its early Phase 1 trial and there is limited evidence regarding efficacy and safety."

Answered by AI
~12 spots leftby Dec 2024