Anaplastic Lymphoma Kinase (ALK)- Positive TumorsNCT05100134
Managed Access Programs for LDK378, Ceritinib
A study testing ceritinib in people with Anaplastic Lymphoma Kinase (ALK)- Positive Tumors and Non-small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals.
Trial summary
The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Anaplastic Lymphoma Kinase (ALK)- Positive Tumors, Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- ceritinib
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An independent request was received from a licensed physician.
- The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
- Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
- Managed Access provision is allowed per local laws/regulations.
Who cannot join
None listed.
About this study
The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.
Read the detailed description
CLDK378A2401 - No longer available - Managed Access Program (MAP) to provide access to Ceritinib, for ALK Positive Tumors.
CLDK378A2402 - No longer available - An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity.
CLDK378A2003M - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.
- Being tested
- ceritinib
- Keywords
- MAP, Manage access program, ceritinib, ALK positive tumors, Non-small cell lung cancer (NSCLC), Anaplastic large cell lymphoma (ALCL), Inflammatory myofibroblastic tumour (IMT),, LDK378
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lymphoma, Large-Cell, Anaplastic, Granuloma, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceritinibDrug
Also called LDK378
Patients receive ceritinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Lymphoma Kinase (ALK)- Positive TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100134
- Sponsor's protocol ID
- CLDK378A2401
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Programs for LDK378, Ceritinib
- ClinicalTrials.gov ID
- NCT05100134
- Acronym / sponsor ID
- CLDK378A2401
- Keywords
- MAP, Manage access program, ceritinib, ALK positive tumors, Non-small cell lung cancer (NSCLC), Anaplastic large cell lymphoma (ALCL), Inflammatory myofibroblastic tumour (IMT),, LDK378
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.
Detailed description
CLDK378A2401 - No longer available - Managed Access Program (MAP) to provide access to Ceritinib, for ALK Positive Tumors.
CLDK378A2402 - No longer available - An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity.
CLDK378A2003M - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.
Study design
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- An independent request was received from a licensed physician.
- The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceritinibAlso: LDK378Patients receive ceritinib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Related trials for Anaplastic Lymphoma Kinase (ALK)- Positive Tumors
RecruitingPhase 1
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive
Active, not recruitingPhase 3
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
Active, not recruitingPhase 4
Lorlatinib Continuation Study
Non-Small-Cell Lung Cancer, NSCLC
RecruitingPhase 1
AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
ALK Positive Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ceritinib in people with Anaplastic Lymphoma Kinase (ALK)- Positive Tumors and Non-small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.