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

Conditions

• NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EP0031 — DRUG
  EP0031 is a potent next-generation selective RET-inhibitor (SRI)
• Platinum chemotherapy — DRUG
  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 — DRUG
  Pemetrexed is a chemotherapy medication and antifolate metabolic inhibitor administered as an IV infusion according to local practice and labels.

Study Details

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 Dates

First listed

Jul 5, 2022

Start date

Sep 30, 2022

Status verified

Jun 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

265 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Module B: Incidence of Dose-limiting Toxicity (DLTs ) during the first 21 days of EP0031 given in combination with SOC chemotherapy treatment [ Time Frame: First 21 days of treatment ]

Central Contacts

• Clinical Trials Team
  +44 20 3743 0992
  [email protected]

Locations (21)

Find similar trials in Los Angeles, CA

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