Advanced Lung Non-Small Cell Carcinoma study: Osimertinib
Official title MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT04762199
What this study is testing
What is MRX-2843?
An investigational oral medicine being studied as a potential treatment for advanced EGFR‑mutant non‑small cell lung cancer. It is designed to block FLT3 and MER tyrosine kinases, interfering with enzymes needed for tumor cell growth.
Also referred to as MRX 2843, MRX2843.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the safest and most effective dose of MRX‑2843 when combined with osimertinib and to learn about side effects.
- Who it's for
- Adults who have advanced or metastatic non‑small cell lung cancer with an EGFR gene mutation.
- What's involved
- Participants will take MRX‑2843 and osimertinib pills and attend regular clinic visits for safety checks, lab tests, and monitoring.
- Time commitment
- The trial lasts several months, with visits and tests scheduled regularly throughout the treatment period.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically confirmed metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation including typical and...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients in the expansion cohort must have measurable disease, defined as at least one lesion that can be accurately measured in at least one...
- Ability to safely swallow oral medication
- Absolute neutrophil count \>= 1500/mm\^3
You likely can't join if
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1)
- Patients who are receiving any other investigational agents
- Patients with symptomatic untreated brain metastases would be excluded from this clinical trial because of their poor prognosis and because they...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MRX-2843 or osimertinib
- Patients with known diagnosis of interstitial lung disease/pneumonitis
See the full eligibility criteria
Who can join
- Patients must have histologically confirmed metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation including typical and atypical mutations in egfr exons 19 and 21
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients in the expansion cohort must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short...
- Ability to safely swallow oral medication
- Absolute neutrophil count \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Hemoglobin \>= 8.5 g/dL (must be \> 2 weeks post-red blood cell transfusion)
- Bilirubin =\< 1.5 x the upper limit of normal (ULN). For people with documented Gilbert's disease, bilirubin =\< 3.0 mg/dL. For people with documented liver metastases, bilirubin =\< 2.5 x ULN
- Serum creatinine =\ = 50 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x the ULN (=\< 5 x the ULN for people with liver metastases)
- 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...
- 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...
- Non-sterilized males who are sexually active with a female of childbearing potential must agree to use an acceptable method of effective contraception from Day 1 and for 90 days after the final dose of study drug
- Female people of childbearing potential must be nonpregnant, and have a negative pregnancy test result at screening and day 1 of cycles 1-6
- Ability to understand and the willingness to sign a written informed consent document
- COHORT SPECIFIC ELIGIBILITY REQUIREMENTS
- Dose Escalation Cohort: Patients with progressive EGFR (+) NSCLC disease; previously treated or naive to EGFR-tyrosine kinase inhibitor (TKI) (previous treatment with 3rd generation EGFR-TKI including osimertinib allowed
- Be treatment naive to osimertinib or any other EGFR TKI,
- If treated with an EGFR TKI in the adjuvant, must have discontinued treatment prior to disease recurrence and be free of recurrence for at least 12 months (+1 day) while off treatment
- Have progression of disease on osimertinib, erlotinib, gefitinib or afatinib as last previous systemic treatment,
- If not previously treated with osimertinib, must be EGFR-T790M negative as confirmed using a standard testing platform (circulating tumor deoxyribonucleic acid [ctDNA] or tissue based testing) prior to study treatment
- Patients must meet the general eligibility requirements but do not meet cohort specific requirements,
- If currently on osimertinib, must have tolerated the standard dose of 80 mg for at least 2 cycles without any grade \> 2 adverse events,
- Will be treated at a dose previously established to be safe from the dose escalation cohort,
- Will not be included in the dose limiting toxicity (DLT) or maximum tolerated dose (MTD) determination,
- Approval by the study sponsor
What rules you out
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1)
- Patients who are receiving any other investigational agents
- Patients with symptomatic untreated brain metastases would be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MRX-2843 or osimertinib
- Patients with known diagnosis of interstitial lung disease/pneumonitis
- Patients with corrected QT (QTc) interval prolongation \> 500 msec (average of 3 readings), family history of congenital long QTc syndrome or torsades
- Patients with known cardiomyopathy or decreased left ventricular ejection fraction (LVEF) \< 50%
- Patient with known history of keratitis or symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye)
- Patients receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s) are ineligible.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Pregnant women are excluded from this study because osimertinib is an agent with the potential for teratogenic or abortifacient effects.
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with osimertinib and MRX-2843.
- Subject has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa
- Subject has a history of type 1 diabetes (T1D) or is considered at high risk for T1D, where high risk is defined as
- Subject has one first-degree relative (defined as parents, offspring or siblings) with T1D and A1C value \> 6.5% or subject with two or more first-degree relatives with T1D
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.