69 Participants Needed

MRX-2843 + Osimertinib for Lung Cancer

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Overseen ByConor Steuer, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Emory University
Must be taking: Osimertinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase Ib trial evaluates the best dose and side effects of MRX-2843 when given in combination with osimertinib in treating patients with EGFR gene mutant non-small cell lung cancer that has spread to other places in the body (advanced). MRX-2843 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot take medications that affect certain liver enzymes (CYP450). It's important to discuss your current medications with the study team to avoid any interactions.

What safety information is available for the treatment MRX-2843 + Osimertinib for lung cancer?

Osimertinib, used in treating certain types of lung cancer, has been associated with common side effects like diarrhea, rash, dry skin, and nail issues. Some patients may experience more serious heart-related side effects, such as changes in heart rhythm and heart failure.12345

What makes the drug MRX-2843 + Osimertinib unique for lung cancer treatment?

The combination of MRX-2843 and Osimertinib is unique because it targets specific mutations in non-small cell lung cancer (NSCLC) that may not respond to other treatments. Osimertinib is a third-generation drug that specifically targets the EGFR T790M mutation, which is often present in patients who have developed resistance to earlier treatments.678910

What data supports the effectiveness of the drug MRX-2843 + Osimertinib for lung cancer?

Osimertinib is effective in treating advanced non-small cell lung cancer (NSCLC) with specific mutations, as it significantly prolongs the time patients live without the disease getting worse compared to older treatments. It is particularly effective for patients with a specific mutation (EGFR T790M) that often causes resistance to other treatments.69111213

Who Is on the Research Team?

Conor E. Steuer, MD | Winship Cancer ...

Conor Steuer

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have enough platelets in your blood.
I agree to use birth control during and up to 4 months after the study.
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.
See 17 more

Exclusion Criteria

I am not taking any drugs that affect liver enzymes.
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
I do not have symptoms from untreated brain metastases.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive osimertinib and MRX-2843 orally once daily on days 1-28, with cycles repeating every 28 days in the absence of disease progression or unacceptable toxicity

28 days per cycle, up to 3.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, for a minimum of 30 days or until resolution of treatment-related toxicity to ≤ grade 1

Minimum of 30 days

What Are the Treatments Tested in This Trial?

Interventions

  • MRX-2843
  • Osimertinib
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (osimertinib, MRX-2843)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Osimertinib is an oral medication specifically designed to target the EGFR T790M mutation in advanced non-small cell lung cancer (NSCLC), which helps overcome resistance to previous EGFR TKI therapies.
It received accelerated approval in the USA in November 2015 for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed after EGFR TKI treatment, and is currently undergoing further development for broader treatment applications.
Osimertinib: First Global Approval.Greig, SL.[2022]
Hsp90 inhibitors, such as ganetespib and luminespib, effectively reduce cell viability and colony formation in osimertinib-resistant non-small cell lung cancer (NSCLC) cell lines, suggesting they can enhance the effectiveness of osimertinib.
The combination of luminespib with osimertinib significantly decreases the expression of key proteins associated with resistance, indicating a potential strategy to overcome resistance in NSCLC patients.
Hsp90 inhibitors enhance the antitumoral effect of osimertinib in parental and osimertinib-resistant non-small cell lung cancer cell lines.Codony-Servat, J., Viteri, S., Codony-Servat, C., et al.[2022]
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor that effectively targets specific mutations in advanced non-small cell lung cancer (NSCLC), including the T790M mutation, leading to significantly longer progression-free survival compared to first-generation EGFR TKIs like erlotinib or gefitinib.
The benefits of osimertinib in prolonging progression-free survival were consistent across all patient groups, regardless of the type of EGFR mutation or the presence of CNS metastases, and it has a generally manageable safety profile.
Osimertinib as first-line therapy in advanced NSCLC: a profile of its use.Scott, LJ.[2020]

Citations

Osimertinib: First Global Approval. [2022]
Hsp90 inhibitors enhance the antitumoral effect of osimertinib in parental and osimertinib-resistant non-small cell lung cancer cell lines. [2022]
Osimertinib as first-line therapy in advanced NSCLC: a profile of its use. [2020]
BTN2A1-BRAF fusion may be a novel mechanism of resistance to osimertinib in lung adenocarcinoma: a case report. [2023]
Histomolecular Resistance Mechanisms to First-Line Osimertinib in EGFR-Mutated Advanced Non-Small Cell Lung Cancer: A Multicentric Retrospective French Study. [2022]
New Adjuvant Drug for Lung Cancer. [2023]
Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer. [2022]
FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation. [2022]
Determination of osimertinib in human plasma, urine and cerebrospinal fluid. [2022]
Multiple cardiotoxicities during osimertinib therapy. [2023]
Osimertinib in non-small cell lung cancer with uncommon EGFR-mutations: a post-hoc subgroup analysis with pooled data from two phase II clinical trials. [2022]
A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study. [2023]
Increased Expression of IRE1α Associates with the Resistant Mechanism of Osimertinib (AZD9291)-resistant non-small Cell Lung Cancer HCC827/OSIR Cells. [2022]
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