A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies

Recruiting now · Phase 1/Phase 2

Conditions studied: NSCLC

In brief

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.

Key facts

Study ID

NCT05443126

Run by

Ellipses Pharma

People needed

265

Starts

2022-09-30

Expected to finish

2028-03-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• 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.

You may not qualify 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
• 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 it is running

• Centro di Riferimento Oncologico IRCCS — Aviano, Italy (enrolling)
• IRCCSS AOU Bologna — Bologna, Italy (enrolling)
• Charité Comprehensive Cancer Center — Berlin, Germany (enrolling)
• Universitätsklinikum Köln — Cologne, Germany (enrolling)
• Florida Cancer Specialists & Research Institute — West Palm Beach, Florida, United States (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• Institut Gustave Roussy — Paris, France (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• The Ohio State University - Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Providence Portland Medical Centre — Portland, Oregon, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States (enrolling)
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Washington University - School of Medicine — Seattle, Washington, United States (enrolling)
• University of Washington - Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Institut Bergonié — Bordeaux, France (enrolling)
• Centre François Baclesse — Caen, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Assistance Publique - Hôpitaux de Marseille — Marseille, France (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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