An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511040-58-00

Acronym

CLDK378A2X01B

Enrollment

Registered

2024-06-13

Start date

2016-01-12

Completion date

Unknown

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non small cell lung cancer

Brief summary

Frequency and severity of AEs/SAEs

Detailed description

Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.

Interventions

DRUGCERITINIB

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency and severity of AEs/SAEs	—

Secondary

Measure	Time frame
Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.	—

Countries

Belgium, Bulgaria, France, Germany, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026