NCT05443126 · Ellipses Pharma
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
What this study is about
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies (NSCLC)
View original scientific description
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies (NSCLC)
Interventions
DRUG
EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
DRUG
Platinum chemotherapy
One of either Cisplatin or Carboplatin. Both agents are potent platinum-based antineoplastic/alkylating agents administered as an IV infusion according to local practice and labels.
DRUG
Pemetrexed
Pemetrexed is a chemotherapy medication and antifolate metabolic inhibitor administered as an IV infusion according to local practice and labels.
Primary outcome measures
Module B: Incidence of Dose-limiting Toxicity (DLTs ) during the first 21 days of EP0031 given in combination with SOC chemotherapy treatment
Time frame: First 21 days of treatment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Applicable to all participants:
- Must be ≥18 years of age, with documented RET-altered NSCLC
- Participants should be well informed and consented about alternative treatment options including approved RET-targeted therapies
- ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
- Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
- Measurable disease defined by RECIST v1.1
- Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive platinum-based doublet chemotherapy.
- First line patients: Must not have received a Selective RET inhibitor or chemotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior. Palliative radiotherapy for symptom management (eg, bone metastases) is permitted up to 2 weeks prior to treatment start.
Exclusion criteria
- Participants with any of the following will not be included in the study:
- Any known major driver gene alterations other than RET.
- Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
- Active infection requiring systemic antibiotic, antifungal, or antiviral medication
- Severe or uncontrolled medical condition or psychiatric condition
- Chronic glomerulonephritis or renal transplant
- Participants with active hepatitis B infection or active hepatitis C
- Participants with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months
- Receipt of any strong inhibitor or inducer of CYP3A4
- Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
- Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months
- Uncontrolled hypertension
- Corneal ulceration or untreated keratitis at screening
Where
- Los Angeles, California
- Stanford, California
- Washington D.C., District of Columbia
- Fort Myers, Florida
- Miami, Florida
- West Palm Beach, Florida
- Chicago, Illinois
- Evanston, Illinois
- Lexington, Kentucky
- Boston, Massachusetts
- Detroit, Michigan
- New York, New York
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations