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New treatment option for NSCLC
Official title A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies
ClinicalTrials.gov ID: NCT05443126
What this study is testing
What is EP0031?
EP0031 is an investigational medicine, being studied as a potential treatment for nsclc.
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 aim of this study is to assess the safety, side effects and effectiveness of EP0031 (Lunbotinib) in patients with advanced RET-altered non-small cell lung cancer (NSCLC) in monotherapy and in combination with standard of care (SOC) chemotherapy.
- Phase 2: a mid-size study of how well it works
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
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- Uncontrolled hypertension
- Corneal ulceration or untreated keratitis at screening
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Stanford, California, United States
- Washington D.C., District of Columbia, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- West Palm Beach, Florida, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Bordeaux, France
+ 24 more site(s).
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 - 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?
Study sites include Los Angeles, California, United States; Stanford, California, United States; Washington D.C., District of Columbia, United States; Fort Myers, Florida, United States; Miami, Florida, United States; West Palm Beach, Florida, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.