Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

265 Participants
are divided into 2 treatment groups
Group A: RET fusion-positive NSCLC (treatment naïve i.e. no prior therapy) in combination w/ SOC chemotherapyExperimental treatment 3 interventions
Group B: RET fusion-positive NSCLC (post-SRI) in combination w/ SOC chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Module B: Overall Response Rate (ORR) as measured using RECIST v1.1

Time frame
12 months
2

Area under the plasma concentration versus time curve (AUC)

To characterise the pharmacokinetics (PK) of EP0031

Time frame
First 24 hours after drug administered
3

Maximum Plasma Concentration (Cmax)

To characterise the pharmacokinetics (PK) of EP0031

Time frame
First 24 hours after drug administered
4

Time taken for drug concentration to fall from half its original value (Half-life)

To characterise the pharmacokinetics (PK) of EP0031

Time frame
First 24 hours after drug administered

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ellipses Pharma

Lead sponsor

Source ClinicalTrials.gov
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