Lunbotinib for Advanced Non-Small Cell Lung Cancer
A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies
Recruiting
Phase 1Phase 2Interventional Study
NSCLC
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
265 (estimated)
Sponsor
Ellipses Pharma · Industry
Who this trial is looking for
This trial is looking for adults with a specific type of lung cancer called RET-altered non-small cell lung cancer. Participants will receive a drug called Lunbotinib, either alone or with standard chemotherapy, and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with RET-altered non-small cell lung cancer.
I can provide written consent and participate in evaluations.
I have measurable cancer that qualifies for treatment.
I have not received certain prior treatments within the last year.
I can expect to live more than 3 months.
I have an ECOG performance status of 0 or 1.
I can receive platinum-based chemotherapy.
You may not be able to join if
I have known major genetic alterations other than RET.
I have spinal cord compression or untreated brain metastases.
I have an uncontrolled medical or psychiatric condition.
I have active hepatitis B or C.
I have uncontrolled hypertension.
I have received strong inhibitors or inducers of CYP3A4.
I have severe heart problems or abnormal ECG results.
I have corneal ulceration or untreated keratitis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 expec…
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 platinum-based doublet chemotherapy.
7. 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.
Exclusion Criteria:
Participants with any of the following will not be included in the study:
1. Any known major driver gene alterations other than RET.
2. Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
3. Active infection requiring systemic antibiotic, antifungal, or antiviral medication
4. Severe or uncontrolled medical condition or psychiatric condition
5. Chronic glomerulonephritis or renal transplant
6. Participants with active hepatitis B infection or active hepatitis C
7. Participants with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months
8. Receipt of any strong inhibitor or inducer of CYP3A4
9. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
10. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months
11. Uncontrolled hypertension
12. Corneal ulceration or untreated keratitis at screening
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.