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
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks
Month 24
Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)
Month 18
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Response Rate (ORR)
Overall Survival (OS)
Time to Response (TTR)
Month 18
Duration of Intracranial Response (DOIR)
Intracranial Disease Control Rate (IDCR)
Overall Intracranial Response Rate (OIRR)
Patient Reported Outcomes (PRO)
from the date of randomization to the date of event for disease related symptoms
Time to Definitive Deterioration
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Arm 1 (PrALKi=Y, PrBRad=Y)
64%Diarrhoea
55%Nausea
52%Vomiting
50%Decreased appetite
43%Alanine aminotransferase increased
43%Aspartate aminotransferase increased
31%Fatigue
29%Headache
26%Asthenia
24%Constipation
24%Cough
21%Non-cardiac chest pain
21%Back pain
19%Oedema peripheral
19%Anaemia
19%Gamma-glutamyltransferase increased
19%Hypokalaemia
17%Abdominal pain
17%Dyspepsia
14%Electrocardiogram QT prolonged
14%Dizziness
14%Weight decreased
14%Abdominal pain upper
14%Pyrexia
14%Musculoskeletal pain
12%Abdominal discomfort
12%Arthralgia
10%Paraesthesia
10%Dyspnoea
10%Muscular weakness
10%Memory impairment
10%Blood creatinine increased
10%Pneumonia
10%Vertigo
10%Gait disturbance
10%Hyperglycaemia
10%Hypophosphataemia
10%Rash
7%Musculoskeletal chest pain
7%Sinus bradycardia
7%Insomnia
7%Seizure
7%Dysphagia
7%Mouth ulceration
7%Stomatitis
7%Upper respiratory tract infection
7%Urinary tract infection
7%Blood alkaline phosphatase increased
7%Lipase increased
7%Muscle spasms
7%Agitation
7%Depression
7%Haemoptysis
7%Productive cough
7%Pruritus
7%Rash maculo-papular
5%Dry skin
5%Respiratory failure
5%Pericardial effusion
5%Pericarditis
5%Tachycardia
5%Epigastric discomfort
5%Influenza like illness
5%Mucosal infection
5%Oral candidiasis
5%Amylase increased
5%Hypoalbuminaemia
5%Pain in extremity
2%Loss of consciousness
2%Vascular purpura
2%Pain
2%Hypophagia
2%Dyspnoea exertional
2%Nephrolithiasis
2%Palpitations
2%Eczema
2%Partial seizures
2%Interstitial lung disease
2%Pleural effusion
2%Hypertension
2%Lung infection pseudomonal
2%Pulmonary embolism
2%Atrial fibrillation
2%Oesophagopleural fistula
2%Salivary hypersecretion
2%Upper gastrointestinal haemorrhage
2%Sudden death
2%Herpes zoster
2%Septic shock
2%Staphylococcal bacteraemia
2%Platelet count decreased
2%Epilepsy
2%Haemorrhage intracranial
2%Hemiparesis
2%Spinal cord compression
2%Acute respiratory failure
2%Pneumothorax
2%Neutropenia
2%Hyperthermia
2%Influenza
2%Hypocalcaemia
2%Dysarthria
2%Somnolence
2%Tremor
2%Anxiety
2%Urinary incontinence
2%Oropharyngeal pain
2%Hyperhidrosis
Trial Design
2 Treatment Groups
Chemotherapy
1 of 2
Ceritinib
1 of 2
Active Control
Experimental Treatment
231 Total Participants · 2 Treatment Groups
Primary Treatment: Ceritinib · No Placebo Group · Phase 3
Ceritinib
Drug
Experimental Group · 1 Intervention: Ceritinib · Intervention Types: DrugChemotherapyActiveComparator Group · 2 Interventions: pemetrexed, docetaxel · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceritinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening, followed by every 6 weeks until month 18 after month 18 every 9 weeks
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,738 Previous Clinical Trials
3,543,983 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- 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.
- 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.
- Shaw AT, Kim TM, Crino L, Gridelli C, Kiura K, Liu G, Novello S, Bearz A, Gautschi O, Mok T, Nishio M, Scagliotti G, Spigel DR, Deudon S, Zheng C, Pantano S, Urban P, Massacesi C, Viraswami-Appanna K, Felip E. 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. Lancet Oncol. 2017 Jul;18(7):874-886. doi: 10.1016/S1470-2045(17)30339-X. Epub 2017 Jun 9.
- 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.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
What are Ceritinib's most common indications?
"Ceritinib is an effective treatment for head, soft tissue sarcoma (sts), and metastatic ureter urothelial carcinoma." - Anonymous Online Contributor
Unverified Answer