Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 17, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: Ceritinib (LDK378); Drug: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
- Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
- Presence of at least one measurable lesion as defined by RECIST 1.1
- Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
- Patient has a WHO performance status 0-1
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years
- Patients with an active, known or suspected autoimmune disease
- Unable or unwilling to swallow tablets or capsules
- Patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic - ArizonaScottsdale, Arizona
- Massachusetts General HospitalBoston, Massachusetts
- Massachusetts General Hospital Thoracic OncolgoyBoston, Massachusetts
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania
- Novartis Investigative SiteHeidelberg, Victoria
- Novartis Investigative SiteLeuven, Vlaams Brabant
- Novartis Investigative SiteToronto, Ontario
- Novartis Investigative SiteHong Kong
- Novartis Investigative SiteMilan, MI
- Novartis Investigative SiteModena, MO
- Novartis Investigative SiteSingapore
- Novartis Investigative SiteBarcelona
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2026. Always confirm current availability with the study team.