Not recruitingRare disease

Study of CLN-081 tablets in patients with non-small cell lung cancer with EGFR exon 20 insertion mutations who have previously received platinum chemotherapy

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates a treatment for patients with Non-Small Cell Lung Cancer that has a specific genetic change called EGFR Exon 20 insertion mutations. The cancer being studied is either locally advanced or has spread to other parts of the body (metastatic). The study focuses on patients whose cancer has continued to grow after receiving treatment with platinum-based chemotherapy.

The study tests a new medication called CLN-081, which comes in tablet form and is taken by mouth. This is a combined Phase 1 and Phase 2 study that aims to understand how safe the medication is, how the body processes it, and how well it works in treating the cancer. The medication will be given twice daily with food.

During the study, doctors will monitor patients' response to treatment and track any side effects that may occur. The study includes different groups of patients and will look at how the medication works both with and without food. Patients will undergo regular health checks and imaging scans to assess how their cancer responds to the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and confirmation
Your diagnosis of locally advanced or metastatic non-small cell lung cancer will be confirmed through tissue examination
Laboratory tests will verify the presence of EGFR exon 20 insertion mutation in your cancer cells
Basic health parameters will be checked, including blood tests, kidney and liver function
Step 2
Treatment initiation
You will receive CLN-081 in tablet form
The medication needs to be taken by mouth twice daily with food
Your ability to swallow pills will be confirmed before starting treatment
Step 3
Regular monitoring
Your tumor response will be measured regularly using imaging scans
Blood tests will be performed to monitor your health status
Side effects will be tracked throughout the treatment period
Step 4
Ongoing assessment
The effectiveness of the treatment will be evaluated based on whether your tumor shrinks (objective response rate)
The duration of the treatment response will be monitored
Your overall health status will be regularly assessed using a standard scale (ECOG performance status)
Step 5
Study completion
The study is planned to continue until March 2025
Your participation duration will depend on how your body responds to the treatment
Final assessments will be conducted to evaluate the overall treatment effectiveness

Who can join the trial?

13 criteria

Must have confirmed advanced or spreading non-small cell lung cancer (for most study parts) or other solid tumors (for specific study part)
Must have a specific genetic change in the EGFR gene (called exon 20 insertion mutation), confirmed by an approved laboratory test
Must have previously received treatment with platinum-based chemotherapy or other standard treatments, unless not suitable for these treatments
Must have tumors that can be measured using standard imaging techniques
Must be at least 18 years old
Must be able to perform daily activities with minimal assistance (ECOG status 0 or 1)
Must be able to swallow pills
Must have acceptable blood test results, including:
- Adequate kidney function
- Normal liver function tests
- Sufficient blood cell counts
- Must provide a tissue sample from the tumor for analysis
- Must be able to understand and sign an informed consent form
- For some parts of the study, must have a negative COVID-19 test before starting

Who cannot join the trial?

12 criteria

History of untreated or active central nervous system (CNS) metastases (spread of cancer to the brain or spinal cord)
Previous treatment with any EGFR exon 20 insertion mutation-specific inhibitor (specific type of targeted therapy)
Active or uncontrolled cardiovascular disease (heart or blood vessel problems)
Known hypersensitivity (severe allergic reaction) to the study drug or its components
Participation in another clinical trial within 30 days before starting this study
Pregnant or breastfeeding women
Active or uncontrolled infections, including hepatitis B, hepatitis C, or HIV
Significant liver problems or abnormal liver function tests
Any condition that could affect the absorption of oral medications
Any other serious medical condition that could interfere with study participation
Unable to swallow oral medications
History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

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Investigated drugs

CLN-081 is an oral medication being studied for the treatment of non-small cell lung cancer. It specifically targets lung cancers that have certain genetic changes called EGFR exon 20 insertion mutations. This medication is designed to work in patients whose cancer has already been treated with platinum-based chemotherapy. It works by blocking specific signals that cancer cells use to grow and spread. The study also includes food interaction testing to understand how the medication works when taken with and without high-fat meals. This helps determine the best way to take the medication with respect to meals for optimal effectiveness.

Cln-081

What is already known about the treatment

CLN-081 - An oral medication being investigated in clinical trials for patients with Non-Small Cell Lung Cancer (NSCLC) who have specific genetic mutations called EGFR Exon 20 insertions. This drug is administered twice daily with food and is being studied in patients who have previously received platinum-based chemotherapy. CLN-081 belongs to the class of targeted therapy agents that work by inhibiting specific genetic mutations in cancer cells, specifically targeting the EGFR pathway that drives tumor growth. The medication is currently undergoing Phase 1/2 clinical trials to establish its safety, effectiveness, and optimal dosing, with particular attention being paid to how food intake affects its absorption and tolerability.

Investigated diseases

Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations - A specific type of lung cancer that develops when certain genetic changes occur in the EGFR gene. This rare form of lung cancer begins in the larger lung cells and is characterized by specific mutations in the exon 20 region of the EGFR gene. The disease affects the lungs' ability to function normally and can spread to other parts of the body. The condition develops when lung cells begin to grow uncontrollably due to these specific genetic mutations. This particular variant represents a distinct subset of non-small cell lung cancer with unique characteristics.