Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with metastatic non-small cell lung cancer (a type of lung cancer that has spread) that has been confirmed by laboratory testing, and whose cancer has a specific gene change (called an EGFR mutation) in certain areas of the gene (exons 19 or 21)
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scoring system (score of 0–2 on the ECOG scale)
• People in the expansion part of the trial who have at least one tumour that is large enough to be measured accurately using X-ray, CT scan, MRI, or physical examination
• People who are able to safely swallow tablets or capsules
• People whose blood test results meet certain minimum levels for white blood cells, platelets, and haemoglobin (red blood cells), measured at least two weeks after any recent blood transfusion
• People whose liver and kidney function blood test results fall within acceptable ranges (specific thresholds may differ for those with liver cancer spread or a condition called Gilbert's disease — confirm with trial site)
• People who agree to use effective contraception during the trial and for a period after finishing treatment (details differ depending on whether the person can become pregnant or can father a child — confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test at the start of the trial and at the beginning of the first six treatment cycles
• People who are willing and able to read and sign an informed consent form
• Dose Escalation Cohort: People whose EGFR-positive lung cancer has progressed, whether or not they have previously received EGFR-targeted treatments (including the drug osimertinib)
• Dose Expansion Cohort A (Treatment naive): People who have never received osimertinib or any other EGFR-targeted treatment, OR people who received an EGFR-targeted treatment after surgery but stopped before the cancer came back and have been cancer-free for at least 12 months since stopping
• Dose Expansion Cohort B (EGFR treatment resistant): People whose cancer has progressed while on osimertinib, erlotinib, gefitinib, or afatinib as their most recent treatment; if not previously treated with osimertinib, a specific gene change (called T790M) must be confirmed absent through standard blood or tissue testing before joining
• Backfill Cohort C: People who meet the general eligibility requirements but do not fit into the other cohorts — for example, people currently on osimertinib without disease progression, or people who cannot wait for other cohorts to open due to their disease; additional requirements apply and sponsor approval is needed (confirm with trial site)

Who may not be able to join:

• People who have received chemotherapy or radiation therapy within the past 4 weeks (or 6 weeks for certain specific chemotherapy drugs)
• People who are still experiencing significant side effects (above a mild level) from previous cancer treatments
• People currently taking part in another clinical trial involving an experimental treatment
• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms and have not yet been treated (people with treated brain metastases, or those without symptoms, may still be eligible)
• People who have had a serious allergic reaction to drugs that are chemically similar to the two study drugs (MRX-2843 or osimertinib)
• People who have been diagnosed with a lung condition called interstitial lung disease or pneumonitis (lung inflammation)
• People who have a prolonged heart electrical interval (called QTc) above a certain level on three readings, or a personal or family history of certain inherited heart rhythm conditions
• People with a known heart muscle condition or reduced heart pumping function (below 50%)
• People with a known history of a cornea condition called keratitis, or who have symptoms such as eye inflammation, excessive tearing, sensitivity to light, blurred vision, eye pain, or red eyes
• People currently taking medications that significantly affect how the body processes certain drugs (CYP450 enzyme inhibitors or inducers — confirm with trial site, as this list changes regularly)
• People with uncontrolled serious health conditions, including active infections, certain heart conditions, or mental health or social circumstances that could affect safe participation in the trial
• People who are pregnant or breastfeeding
• People living with HIV who are on combination antiretroviral therapy
• People with a known or suspected personal or family history of a retinal condition called retinitis pigmentosa
• People with a personal history of type 1 diabetes, or those considered at high risk — defined as having one close family member (parent, sibling, or child) with type 1 diabetes and a blood sugar marker (HbA1c) above 6.5%, or having two or more close family members with type 1 diabetes

Important: Always verify eligibility with the trial site directly before applying.