Ellipses Pharma
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.
EP0031 is being investigated in this modular, interventional Phase I/II dose escalation and dose expansion study to investigate the optimal dose in adult patients with advanced RET-altered NSCLC. Currently there are no approved RET-targeted treatments for patients who progress on first-generation Selective RET Inhibitors (SRIs). However, it is proposed that EP0031 can overcome resistance mechanisms to first generation SRIs, as EP0031 is a potent and selective RET inhibitor with broad activity against common RET fusions and mutations. Phase I (dose escalation and optimization) has completed for…
Inclusion Criteria: Applicable to all participants: 1. Must be ≥18 years of age, with documented RET-altered NSCLC 2. Participants should be well informed and consented about alternative treatment options including approved RET-targeted therapies 3. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening 4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures 5. Measurable disease defined by RECIST v1.1 6. Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive pl…
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
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.
Pemetrexed is a chemotherapy medication and antifolate metabolic inhibitor administered as an IV infusion according to local practice and labels.