← Back to Search

ALK Inhibitor

Ceritinib for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, followed by every 6 weeks until month 18 after month 18 every 9 weeks
Awards & highlights

Study Summary

This trial compared the effectiveness of LDK378 to chemotherapy in patients who had already been treated with both chemotherapy and crizotinib.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, followed by every 6 weeks until month 18 after month 18 every 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, followed by every 6 weeks until month 18 after month 18 every 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Intracranial Response (DOIR)
Duration of Response (DOR)
+7 more

Side effects data

From 2023 Phase 3 trial • 231 Patients • NCT01828112
70%
Diarrhoea
63%
Nausea
50%
Vomiting
43%
Alanine Aminotransferase Increased
42%
Decreased Appetite
37%
Aspartate Aminotransferase Increased
30%
Weight Decreased
27%
Fatigue
23%
Blood Alkaline Phosphatase Increased
23%
Gamma-Glutamyltransferase Increased
22%
Back Pain
22%
Asthenia
22%
Abdominal Pain
19%
Headache
19%
Constipation
19%
Blood Creatinine Increased
16%
Abdominal Pain Upper
15%
Pyrexia
14%
Cough
12%
Non-Cardiac Chest Pain
11%
Rash
11%
Electrocardiogram Qt Prolonged
11%
Dyspnoea
10%
Arthralgia
10%
Nasopharyngitis
10%
Musculoskeletal Pain
9%
Dizziness
9%
Pruritus
9%
Hypokalaemia
8%
Musculoskeletal Chest Pain
7%
Hyperglycaemia
7%
Insomnia
6%
Amylase Increased
6%
Neck Pain
5%
Alopecia
5%
Dry Skin
5%
Anaemia
5%
Malaise
5%
Pain In Extremity
4%
Pleural Effusion
4%
General Physical Health Deterioration
4%
Pneumonia
4%
Stomatitis
4%
Productive Cough
3%
Neutropenia
3%
Respiratory Failure
3%
Paraesthesia
3%
Oedema Peripheral
3%
Pericardial Effusion
3%
Myalgia
2%
Dehydration
2%
Leukopenia
2%
White Blood Cell Count Decreased
2%
Respiratory Tract Infection
2%
Epilepsy
2%
Atrial Fibrillation
2%
Muscular Weakness
1%
Pericarditis
1%
Visual Field Defect
1%
Neuropathy Peripheral
1%
Petit Mal Epilepsy
1%
Lower Respiratory Tract Infection
1%
Gastrointestinal Obstruction
1%
Gastrointestinal Perforation
1%
Lung Infiltration
1%
Cerebrovascular Accident
1%
Loss Of Consciousness
1%
Urinary Bladder Rupture
1%
Lenticular Opacities
1%
Dysphagia
1%
Electrocardiogram T Wave Inversion
1%
Faecaloma
1%
Jaundice
1%
Hyponatraemia
1%
Mobility Decreased
1%
Aphasia
1%
Biliary Tract Infection
1%
Brain Mass
1%
Typhoid Fever
1%
Surgery
1%
Neutrophil Count Decreased
1%
Chest Pain
1%
Cognitive Disorder
1%
Coordination Abnormal
1%
Depressed Level Of Consciousness
1%
Hypoxia
1%
Interstitial Lung Disease
1%
Respiratory Distress
1%
Deep Vein Thrombosis
1%
Seizure
1%
Atrial Flutter
1%
Myocardial Ischaemia
1%
Pathological Fracture
1%
Metastases To Central Nervous System
1%
Tumour Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceritinib
Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CeritinibExperimental Treatment1 Intervention
Patients in this arm received 750 mg of ceritinib.
Group II: ChemotherapyActive Control2 Interventions
Patients in this arm received chemotherapy of either pemetrexed or docetaxel as determined by BIRC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceritinib
2013
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,865 Previous Clinical Trials
4,199,056 Total Patients Enrolled

Media Library

Ceritinib (ALK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01828112 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Ceritinib, Chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Ceritinib Highlights & Side Effects. Trial Name: NCT01828112 — Phase 3
Ceritinib (ALK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01828112 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different medical facilities in this state are testing this new medication?

"This trial has 14 enrolling patients, including Cancer Specialists of North Florida in Jacksonville, Texas Oncology Cancer Care and Research Center in Waco, and Swedish Cancer Institute SC-1 in Seattle, as well as other sites."

Answered by AI

What was the outcome of the FDA's review of ceritinib?

"Ceritinib is considered safe due to its Phase 3 status and supporting data, scoring a 3 on Power's safety scale."

Answered by AI

Are there other existing studies that have used Ceritinib in the past?

"Presently, 557 clinical trials are underway to research Ceritinib. Of those active studies, 216 are in Phase 3. The majority of studies are based in Fuzhou, Fujian; however, there are 39014 locations running trials for this medication globally."

Answered by AI

What are Ceritinib's most common indications?

"Ceritinib is an effective treatment for head, soft tissue sarcoma (sts), and metastatic ureter urothelial carcinoma."

Answered by AI
Recent research and studies
Japanese Journal of Clinical OncologyJournal
Phase 3 Study of Ceritinib Vs Chemotherapy in Alk-rearranged NSCLC Patients Previously Treated with Chemotherapy and Crizotinib (ASCEND-5): Japanese Subset
Kiura, Katsuyuki, Fumio Imamura, Hiroshi Kagamu, Shingo Matsumoto, Toyoaki Hida, Kazuhiko Nakagawa, Miyako Satouchi, et al.. 2018. “Phase 3 Study of Ceritinib Vs Chemotherapy in Alk-rearranged NSCLC Patients Previously Treated with Chemotherapy and Crizotinib (ASCEND-5): Japanese Subset”. Japanese Journal of Clinical Oncology. Oxford University Press (OUP). doi:10.1093/jjco/hyy016.
The Lancet OncologyJournal
Ceritinib Versus Chemotherapy in Patients with Alk-rearranged Non-small-cell Lung Cancer Previously Given Chemotherapy and Crizotinib (ASCEND-5): A Randomised, Controlled, Open-label, Phase 3 Trial
Shaw, Alice T, Tae Min Kim, Lucio Crinò, Cesare Gridelli, Katsuyuki Kiura, Geoffrey Liu, Silvia Novello, et al.. 2017. “Ceritinib Versus Chemotherapy in Patients with Alk-rearranged Non-small-cell Lung Cancer Previously Given Chemotherapy and Crizotinib (ASCEND-5): A Randomised, Controlled, Open-label, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(17)30339-x.
clinicaltrials.govStudy
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
2013. "LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01828112.
~20 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top