Non-Small Cell Lung Cancer (NSCLC) Clinical Trials
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A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0031 in Patients With Advanced RET-altered Malignancies
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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.
Locations
United States
California
David Geffen School of Medicine at UCLA
RECRUITING
Los Angeles
Stanford University
RECRUITING
Stanford
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
Florida Cancer Specialist
TERMINATED
Fort Myers
University of Miami - Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Florida Cancer Specialists & Research Institute
RECRUITING
West Palm Beach
Illinois
RUSH University Medical Center
TERMINATED
Chicago
Northwestern University
RECRUITING
Evanston
Kentucky
University of Kentucky
TERMINATED
Lexington
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Karmanos
TERMINATED
Detroit
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
The Ohio State University - Comprehensive Cancer Center
RECRUITING
Columbus
Oregon
Providence Portland Medical Centre
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University
WITHDRAWN
Philadelphia
Tennessee
Sarah Cannon Research Institute
TERMINATED
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
University of Washington - Fred Hutchinson Cancer Center
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
RECRUITING
Torino
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
NOT_YET_RECRUITING
Warsaw
Spain
Hospital Universitario de A Coruña
RECRUITING
A Coruña
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Madrid Sanchinarro
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Virgen de la Victoria de Malaga
RECRUITING
Málaga
United Arab Emirates
Cleveland Clinic Abu Dhabi (CCAD)
RECRUITING
Abu Dhabi
Sheik Shakhbout Medical City (SSMC)
RECRUITING
Abu Dhabi
Tawam Hospital
RECRUITING
Al Ain City
United Kingdom
Guy's and St Thomas' Hospital NHSFT
RECRUITING
London
The Royal Marsden NHSFT
RECRUITING
London
University College London Hospital (UCLH)
RECRUITING
London
The Christie Hospital NHSFT
RECRUITING
Manchester
Sheffield Teaching Hospitals NHSFT
WITHDRAWN
Sheffield
Contact Information
Primary
Clinical Trials Team
Enquires@ellipses.life
+44 20 3743 0992
Time Frame
Start Date:2022-09-30
Estimated Completion Date:2028-03
Participants
Target number of participants:265
Treatments
Experimental: RET fusion-positive NSCLC (treatment naïve i.e. no prior therapy) in combination w/ SOC chemotherapy
Cohort for eligible patients with no prior first line treatment with a 1st gen SRI or chemotherapy.~EP0031 capsules at the recommended dose, taken once daily, in combination with doublet platinum-based SOC chemotherapy, both administered on Day 1 of 21-day cycles for 4 cycles, followed by EP0031 plus pemetrexed maintenance until progressive disease (PD), unacceptable toxicity or patient withdrawal
Experimental: RET fusion-positive NSCLC (post-SRI) in combination w/ SOC chemotherapy
Cohort for eligible patients treated previously with a 1st gen SRI.~COHORT IS NOW CLOSED TO RECRUITMENT.~EP0031 capsules at the recommended dose, taken once daily, in combination with doublet platinum-based SOC chemotherapy, both administered on Day 1 of 21-day cycles for 4 cycles, followed by EP0031 plus pemetrexed maintenance until progressive disease (PD), unacceptable toxicity or patient withdrawal