Adults 18 to 100, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)Primary· From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 34 months
PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method.
Group
Value
95% CI
Ceritinib
16.6
12.6 – 27.2
Chemotherapy
8.1
5.8 – 11.1
Overall Survival (OS)Secondary· From date of randomization to date of death due to any cause, up to approximately 120 months
OS defined as time from date of randomization to date of death due to any cause.
If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date. The distribution of OS was estimated using the KM method.
Group
Value
95% CI
Ceritinib
62.9
44.2 – 77.6
Chemotherapy
40.7
28.5 – 54.5
Overall Response Rate (ORR) by BIRC AssessmentSecondary· Up to approximately 34 months
ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by BIRC per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Group
Value
95% CI
Ceritinib
72.5
65.5 – 78.7
Chemotherapy
26.7
20.5 – 33.7
Overall Response Rate (ORR) by Investigator AssessmentSecondary· Up to approximately 120 months
ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by investigator assessment per RECIST 1.1.
CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Group
Value
95% CI
Ceritinib
73.5
66.7 – 79.7
Chemotherapy
33.2
26.5 – 40.4
Duration of Response (DOR) by BIRC AssessmentSecondary· From first documented response to first documented disease progression or death, assessed up to approximately 34 months
DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by BIRC assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution f
Group
Value
95% CI
Ceritinib
23.9
16.6 – NA
Chemotherapy
11.1
7.8 – 16.4
Duration of Response (DOR) by Investigator AssessmentSecondary· From first documented response to first documented disease progression or death, assessed up to approximately 120 months
DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by investigator assessment per RECIST 1.1) or death due to any cause.
CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distr
Group
Value
95% CI
Ceritinib
22.6
17.7 – 26.2
Chemotherapy
9.8
6.1 – 16.9
Disease Control Rate (DCR) by BIRC AssessmentSecondary· Up to approximately 34 months
DCR is defined as the percentage of patients with best overall response of CR, PR, or stable disease (SD) measured by BIRC assessment per RECIST 1.1.
CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Group
Value
95% CI
Ceritinib
84.7
78.7 – 89.5
Chemotherapy
73.8
66.9 – 79.9
Disease Control Rate (DCR) by Investigator AssessmentSecondary· Up to approximately 120 months
DCR is defined as the percentage of patients with best overall response of CR, PR, or stable disease (SD) measured by investigator assessment per RECIST 1.1.
CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Group
Value
95% CI
Ceritinib
89.4
84.1 – 93.4
Chemotherapy
75.9
69.2 – 81.9
Time to Response (TTR) by BIRC AssessmentSecondary· From randomization to date of first documented response, up to approximately 34 months
TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by BIRC assessment per RECIST 1.1.
CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event.
Group
Value
95% CI
Ceritinib
6.14
5.1 – 61.7
Chemotherapy
13.36
5.1 – 90.1
Time to Response (TTR) by Investigator AssessmentSecondary· From randomization to date of first documented response, up to approximately 120 months
TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by investigator assessment per RECIST 1.1.
CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event
Group
Value
95% CI
Ceritinib
6.29
5.1 – 71.9
Chemotherapy
12.71
4.7 – 461.6
PFS by Investigator AssessmentSecondary· From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 120 months
PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by investigator assessment per RECIST 1.1) or death due to any cause.
A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the KM method.
Group
Value
95% CI
Ceritinib
16.8
13.5 – 22.8
Chemotherapy
7.2
5.8 – 9.7
Overall Intracranial Response Rate (OIRR)Secondary· Up to approximately 34 months
OIRR is defined as the ORR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated as the percentage of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1 as assessed by BIRC neuroradiologist.
CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Group
Value
95% CI
Ceritinib
72.7
49.8 – 89.3
Chemotherapy
27.3
10.7 – 50.2
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ceritinib
Serious: 93/189 (49%)
Deaths: 15/189
Chemotherapy
Serious: 64/175 (37%)
Deaths: 10/187
Chemotherapy to Ceritinib (Extension-treatment)
Serious: 47/100 (47%)
Deaths: 15/100
Ceritinib (Post-treatment Follow-up)
Serious: 0
Deaths: 98/149
Chemotherapy (Post-treatment Follow-up)
Serious: 0
Deaths: 38/60
Chemotherapy to Ceritinib (Post-treatment Follow-up)
Serious: 0
Deaths: 56/83
Serious adverse events (200 terms)
Reaction
System
Ceritinib
Chemotherapy
Chemotherapy to Ceritinib …
Ceritinib (Post-treatment …
Chemotherapy (Post-treatme…
Chemotherapy to Ceritinib …
Pneumonia
Infections and infestations
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Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
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Vomiting
Gastrointestinal disorders
—
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—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
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—
Nausea
Gastrointestinal disorders
—
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—
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—
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Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
—
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Pyrexia
General disorders
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Hyperglycaemia
Metabolism and nutrition disorders
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Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To compare the efficacy and safety of ceritinib with standard first-line chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with stage IIIB (not candidates for definitive multimodality therapy) or stage IV, non-squamous non-small cell lung cancer (NSCLC) harboring a confirmed anaplastic lymphoma kinase (ALK) rearrangement, using the Ventana immunohistochemistry (IHC) test.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06813079 — Using Tumor Models to Determine Treatments
· Phase 2
· not yet recruiting
NCT03784014 — Molecular Profiling of Advanced Soft-tissue Sarcomas
· Phase 3
· active not recruiting
NCT03737994 — Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cance
· Phase 2
· active not recruiting
NCT03546894 — A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastati
· completed
NCT03501368 — Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 16 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01828099.