A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies
ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEllipses Pharma
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- EP0031
- Platinum chemotherapy
- Pemetrexed
Treatment groups
265 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov