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Study on Continued Ceritinib Treatment for Patients with ALK Positive Non-Small Cell Lung Cancer

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What is this trial about?

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

This clinical trial focuses on patients with non-small cell lung cancer, a type of lung cancer that is common and can be challenging to treat. The study involves the medication ceritinib, also known by its code name LDK378. Ceritinib is taken in the form of a hard capsule and is designed to help patients who have a specific type of cancer known as ALK-positive malignancies. This means that their cancer cells have a change in the ALK gene, which can promote cancer growth.

The purpose of this study is to provide patients with continued access to ceritinib after they have completed a previous study sponsored by Novartis, a pharmaceutical company. The study aims to gather information on the long-term safety of ceritinib, focusing on any side effects or adverse events that may occur. Patients who are already receiving ceritinib and are believed to benefit from ongoing treatment will continue to take the medication as part of this trial.

Participants in the study will continue their treatment with ceritinib under the supervision of their healthcare provider. The study will monitor the frequency and severity of any side effects, as well as assess the overall benefit of the treatment for each patient. This trial is designed to ensure that patients who have shown positive results from ceritinib can maintain their treatment and potentially improve their health outcomes.

The research process

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

  1. Step 1

    Enrollment in the study

    Enrollment occurs after completing a previous study involving ceritinib and being assessed by the investigator as benefiting from continued treatment.

    Written informed consent is required before joining the study and receiving the medication.

  2. Step 2

    Treatment with ceritinib

    Ceritinib is administered orally. The specific dosage and frequency are determined by the investigator based on individual needs.

    The treatment continues as long as the investigator believes there is a benefit.

  3. Step 3

    Scheduled visits

    Regular visits are scheduled to monitor the treatment's effectiveness and safety.

    During these visits, the investigator assesses the clinical benefit and any side effects experienced.

  4. Step 4

    Monitoring of side effects

    The study focuses on collecting data about the frequency and severity of any side effects.

    This information helps in understanding the long-term safety of ceritinib.

  5. Step 5

    Study conclusion

    The study is estimated to conclude by November 16, 2025.

    Continued participation is based on the investigator's assessment of the treatment's benefit.

Who can join the trial?

7 criteria

  • The patient must have non-small cell lung cancer, which is a type of lung cancer.
  • The patient is currently receiving treatment with a drug called ceritinib in a study sponsored by Novartis. The study must have met its main goals, and the doctor believes the patient would benefit from continuing the treatment.
  • The patient has followed the rules and requirements of the previous study, as checked by the doctor.
  • The patient is willing and able to attend scheduled visits, follow treatment plans, and participate in any other study procedures.
  • The patient must provide written informed consent before joining the new study and receiving the study medication. If the patient cannot write, the consent must be formally recorded and witnessed, preferably by an independent trusted person.
  • The study is open to both male and female patients.
  • The study includes patients from vulnerable populations, which means it considers those who might need extra protection or care.

Who cannot join the trial?

5 criteria

  • Patients who do not have non-small cell lung cancer cannot participate. This is a type of lung cancer.
  • Patients who are not within the specified age ranges cannot participate. The age ranges are typically defined by the study.
  • Patients who are not part of the specified clinical trial groups cannot participate. These groups are usually defined by the study.
  • Both male and female patients are considered for participation, so gender is not an exclusion criterion.
  • Patients who are part of a vulnerable population may be excluded. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

Ceritinib is a medication used in this clinical trial for patients with ALK-positive malignancies. It is designed to help treat certain types of cancer by targeting and inhibiting the activity of a specific protein that promotes cancer cell growth. This trial aims to provide continued access to ceritinib for patients who have previously participated in a Novartis-sponsored study and are still benefiting from the treatment. The focus is on evaluating the long-term safety of the medication.

What is already known about the treatment

Ceritinib – Ceritinib is administered orally in the form of capsules. It is currently used in the treatment of non-small cell lung cancer, specifically in patients with ALK-positive malignancies. The medication works by inhibiting the activity of the anaplastic lymphoma kinase (ALK) enzyme, which is involved in the growth and spread of cancer cells. Ceritinib is classified as a tyrosine kinase inhibitor, and it is being studied in clinical trials to gather long-term safety data and provide continued access to patients who benefit from its use.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511040-58-00Protocol codeCLDK378A2X01BEstimated enrolment223 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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