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

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What is this study about?

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.

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

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

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

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)

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Hm Nou Delfos Barcelona Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hlnwatnv Ugeptwxravnzy Roqfvjxa Dc Mqlzgn Malaga Spain
Peql Tdwrj Hxeqexyv Uappxfblfvfm Sabadell Spain
Ickkqoul Rietnhtud Pdx Ly Shtsaa Daq Tpslup Dzag Abgqzla Ilwe Sgmvzn Meldola Italy
Llmoh Ucbwvctbfbpb Mdkngsl Coafvzh (zfjmf Leiden The Netherlands
Iyyvamyl Cmcnem Dvgbsmrqnfirusnfd L'hospitalet De Llobregat Spain
Hjfqhtue Vgef dailuyoq Barcelona Spain
Hvyyzazl Uruowqetkdntm dx A Cileka A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
05.11.2019
Spain Spain
Not recruiting
05.11.2019
The Netherlands The Netherlands
Not recruiting
05.11.2019

Trial locations

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.

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.

Trial ID:
2024-516532-97-00
Protocol code:
CLN-081-001
NCT ID:
NCT04036682
Trial Phase:
Human Pharmacology (Phase I) – Other

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