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LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828099
Recruitment Status : Active, not recruiting
First Posted : April 10, 2013
Results First Posted : September 21, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Ceritinib
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Enrollment 375
Recruitment Details Patients were randomized in a 1:1 ratio to either ceritinib (750 mg once daily fasted) or chemotherapy (platinum-based doublet with pemetrexed followed by pemetrexed maintenance in patients without progressive disease after 4 cycles).
Pre-assignment Details 376 patients completed the screening phase and were randomized to either ceritinib or chemotherapy arm in the treatment phase. 12 patients randomized to the chemotherapy arm were not treated. All patient randomized to ceritinib were treated.
Arm/Group Title Ceritinib Chemotherapy
Hide Arm/Group Description Ceritinib 750 mg Chemotherapy patients (Induction per Investigator’s choice)
Period Title: Overall Study
Started 189 187
Untreated Patients 0 12
Treated 189 [1] 175
Discontinued From Treatment Phase 94 157
Entered Extension-treatment Phase 0 81
Entered Post-treatment Follow-up Phase 10 16
Entered Survival Follow-up Phase 64 31
Discontinued From Study 20 29
Completed 95 [2] 30 [2]
Not Completed 94 157
Reason Not Completed
Adverse Event             15             18
Death             9             11
Lost to Follow-up             2             0
Non-compliance with study treatment             2             0
Physician Decision             7             11
Progressive disease             51             94
Protocol Violation             1             0
Subject/guardian decision             7             23
[1]
discontinued from treatment phase = Not completed
[2]
Completed = Patients ongoing at the time of data cut-off of 24-Jun-2016
Arm/Group Title Ceritinib Chemotherapy Total
Hide Arm/Group Description Ceritinib 750 mg Chemotherapy patients (Induction per Investigator’s choice) Total of all reporting groups
Overall Number of Baseline Participants 189 187 376
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 189 participants 187 participants 376 participants
54.5  (12.76) 53.3  (12.49) 53.9  (12.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 187 participants 376 participants
Female
102
  54.0%
114
  61.0%
216
  57.4%
Male
87
  46.0%
73
  39.0%
160
  42.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 187 participants 376 participants
Asian
76
  40.2%
82
  43.9%
158
  42.0%
Black
3
   1.6%
3
   1.6%
6
   1.6%
Caucasian
104
  55.0%
98
  52.4%
202
  53.7%
Native American
3
   1.6%
2
   1.1%
5
   1.3%
Other
3
   1.6%
2
   1.1%
5
   1.3%
1.Primary Outcome
Title Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)
Hide Description PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause
Time Frame from the date of randomization to the date of first radiologically documented disease progression or death due to any cause (assessed every 6 weeks up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.
Arm/Group Title Ceritinib Chemotherapy
Hide Arm/Group Description:
Ceritinib 750 mg
Chemotherapy patients (Induction per Investigator’s choice)
Overall Number of Participants Analyzed 189 187
Median (95% Confidence Interval)
Unit of Measure: months
16.6
(12.6 to 27.2)
8.1
(5.8 to 11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceritinib, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Stratisfied Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.42 to 0.73
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS defined as time from date of randomization to date of death due to any cause
Time Frame From randomization until death (up to approximately 34 months)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Review Committee (BIRC) and by investigator assessment per RECIST 1.1
Time Frame From randomization until death (up to approximately 34 months)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
Time Frame From randomization until death (up to approximately 34 months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)
Time Frame From randomization until death (up to approximately 34 months)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to Response (TTR)
Hide Description TTR defined as the time from date of randomization to date of first documented response (CR or PR)
Time Frame From randomization until death (up to approximately 34 months)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Patient Reported Outcomes
Hide Description The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms.
Time Frame Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks.
Outcome Measure Data Not Reported
Time Frame Adverse Events are collected from First Patient First Visit (FPFV) until at least 30 days following the last dose of study treatment. AEs reported in this record are from FPFT until data cutoff for primary analysist.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ceritinib Chemotherapy
Hide Arm/Group Description Ceritinib 750 mg Chemotherapy patients (Induction per Investigator’s choice)
All-Cause Mortality
Ceritinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ceritinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   70/189 (37.04%)   62/175 (35.43%) 
Blood and lymphatic system disorders     
Anaemia  1  1/189 (0.53%)  4/175 (2.29%) 
Febrile Neutropenia  1  0/189 (0.00%)  1/175 (0.57%) 
Leukopenia  1  0/189 (0.00%)  1/175 (0.57%) 
Thrombocytopenia  1  0/189 (0.00%)  2/175 (1.14%) 
Cardiac disorders     
Acute Myocardial Infarction  1  1/189 (0.53%)  1/175 (0.57%) 
Atrial Fibrillation  1  2/189 (1.06%)  2/175 (1.14%) 
Atrial Flutter  1  1/189 (0.53%)  0/175 (0.00%) 
Cardiac Arrest  1  0/189 (0.00%)  1/175 (0.57%) 
Cardiac Failure  1  0/189 (0.00%)  1/175 (0.57%) 
Cardiac Tamponade  1  1/189 (0.53%)  0/175 (0.00%) 
Myocardial Infarction  1  1/189 (0.53%)  0/175 (0.00%) 
Myocardial Ischaemia  1  1/189 (0.53%)  0/175 (0.00%) 
Nodal Rhythm  1  1/189 (0.53%)  0/175 (0.00%) 
Pericardial Effusion  1  4/189 (2.12%)  2/175 (1.14%) 
Congenital, familial and genetic disorders     
Hydrocele  1  1/189 (0.53%)  0/175 (0.00%) 
Endocrine disorders     
Adrenocortical Insufficiency Acute  1  0/189 (0.00%)  1/175 (0.57%) 
Eye disorders     
Blindness  1  0/189 (0.00%)  1/175 (0.57%) 
Gastrointestinal disorders     
Abdominal Distension  1  1/189 (0.53%)  0/175 (0.00%) 
Abdominal Pain Upper  1  1/189 (0.53%)  0/175 (0.00%) 
Diarrhoea  1  3/189 (1.59%)  3/175 (1.71%) 
Dysphagia  1  0/189 (0.00%)  1/175 (0.57%) 
Food Poisoning  1  1/189 (0.53%)  0/175 (0.00%) 
Intestinal Obstruction  1  0/189 (0.00%)  1/175 (0.57%) 
Lower Gastrointestinal Haemorrhage  1  0/189 (0.00%)  1/175 (0.57%) 
Nausea  1  6/189 (3.17%)  5/175 (2.86%) 
Upper Gastrointestinal Haemorrhage  1  1/189 (0.53%)  0/175 (0.00%) 
Vomiting  1  7/189 (3.70%)  6/175 (3.43%) 
General disorders     
Asthenia  1  1/189 (0.53%)  0/175 (0.00%) 
Chest Discomfort  1  0/189 (0.00%)  1/175 (0.57%) 
Death  1  1/189 (0.53%)  0/175 (0.00%) 
Fatigue  1  2/189 (1.06%)  2/175 (1.14%) 
General Physical Health Deterioration  1  2/189 (1.06%)  1/175 (0.57%) 
Malaise  1  2/189 (1.06%)  1/175 (0.57%) 
Non-Cardiac Chest Pain  1  2/189 (1.06%)  0/175 (0.00%) 
Pyrexia  1  2/189 (1.06%)  5/175 (2.86%) 
Hepatobiliary disorders     
Hepatic Function Abnormal  1  2/189 (1.06%)  0/175 (0.00%) 
Liver Injury  1  1/189 (0.53%)  0/175 (0.00%) 
Infections and infestations     
Amoebic Dysentery  1  1/189 (0.53%)  0/175 (0.00%) 
Arthritis Infective  1  1/189 (0.53%)  0/175 (0.00%) 
Brain Abscess  1  1/189 (0.53%)  0/175 (0.00%) 
Bronchitis  1  0/189 (0.00%)  1/175 (0.57%) 
Cellulitis  1  1/189 (0.53%)  0/175 (0.00%) 
Diarrhoea Infectious  1  0/189 (0.00%)  1/175 (0.57%) 
Erysipelas  1  0/189 (0.00%)  1/175 (0.57%) 
Escherichia Urinary Tract Infection  1  1/189 (0.53%)  0/175 (0.00%) 
Eye Abscess  1  0/189 (0.00%)  1/175 (0.57%) 
Febrile Infection  1  0/189 (0.00%)  1/175 (0.57%) 
Gastroenteritis  1  1/189 (0.53%)  0/175 (0.00%) 
Helicobacter Gastritis  1  1/189 (0.53%)  0/175 (0.00%) 
Herpes Zoster  1  0/189 (0.00%)  1/175 (0.57%) 
Influenza  1  0/189 (0.00%)  1/175 (0.57%) 
Localised Infection  1  1/189 (0.53%)  0/175 (0.00%) 
Lung Abscess  1  1/189 (0.53%)  0/175 (0.00%) 
Lung Infection  1  3/189 (1.59%)  4/175 (2.29%) 
Mastoiditis  1  1/189 (0.53%)  0/175 (0.00%) 
Otitis Media Acute  1  1/189 (0.53%)  0/175 (0.00%) 
Pneumocystis Jirovecii Pneumonia  1  1/189 (0.53%)  0/175 (0.00%) 
Pneumonia  1  8/189 (4.23%)  5/175 (2.86%) 
Pneumonia Bacterial  1  0/189 (0.00%)  1/175 (0.57%) 
Pneumonia Cytomegaloviral  1  1/189 (0.53%)  0/175 (0.00%) 
Pyomyositis  1  1/189 (0.53%)  0/175 (0.00%) 
Respiratory Tract Infection  1  1/189 (0.53%)  0/175 (0.00%) 
Salmonella Sepsis  1  1/189 (0.53%)  0/175 (0.00%) 
Sepsis  1  0/189 (0.00%)  2/175 (1.14%) 
Septic Shock  1  0/189 (0.00%)  2/175 (1.14%) 
Upper Respiratory Tract Infection  1  0/189 (0.00%)  1/175 (0.57%) 
Urinary Tract Infection  1  0/189 (0.00%)  2/175 (1.14%) 
Injury, poisoning and procedural complications     
Abdominal Injury  1  1/189 (0.53%)  0/175 (0.00%) 
Facial Bones Fracture  1  1/189 (0.53%)  0/175 (0.00%) 
Investigations     
Alanine Aminotransferase Increased  1  3/189 (1.59%)  0/175 (0.00%) 
Aspartate Aminotransferase Increased  1  4/189 (2.12%)  0/175 (0.00%) 
Blood Creatinine Increased  1  3/189 (1.59%)  0/175 (0.00%) 
Blood Potassium Decreased  1  0/189 (0.00%)  1/175 (0.57%) 
C-Reactive Protein Increased  1  1/189 (0.53%)  0/175 (0.00%) 
Electrocardiogram Qt Prolonged  1  1/189 (0.53%)  0/175 (0.00%) 
Gamma-Glutamyltransferase Increased  1  1/189 (0.53%)  0/175 (0.00%) 
Neutrophil Count Decreased  1  1/189 (0.53%)  0/175 (0.00%) 
Transaminases Increased  1  0/189 (0.00%)  1/175 (0.57%) 
Weight Decreased  1  1/189 (0.53%)  0/175 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/189 (0.53%)  2/175 (1.14%) 
Hypercalcaemia  1  1/189 (0.53%)  0/175 (0.00%) 
Hyperglycaemia  1  5/189 (2.65%)  1/175 (0.57%) 
Hypoglycaemia  1  0/189 (0.00%)  2/175 (1.14%) 
Hypokalaemia  1  1/189 (0.53%)  1/175 (0.57%) 
Hypomagnesaemia  1  0/189 (0.00%)  1/175 (0.57%) 
Hyponatraemia  1  1/189 (0.53%)  0/175 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/189 (0.00%)  1/175 (0.57%) 
Back Pain  1  3/189 (1.59%)  2/175 (1.14%) 
Bone Pain  1  0/189 (0.00%)  1/175 (0.57%) 
Musculoskeletal Chest Pain  1  0/189 (0.00%)  1/175 (0.57%) 
Pain In Extremity  1  1/189 (0.53%)  0/175 (0.00%) 
Pathological Fracture  1  0/189 (0.00%)  1/175 (0.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung Cancer Metastatic  1  1/189 (0.53%)  0/175 (0.00%) 
Lung Neoplasm Malignant  1  1/189 (0.53%)  0/175 (0.00%) 
Malignant Neoplasm Progression  1  1/189 (0.53%)  0/175 (0.00%) 
Metastases To Central Nervous System  1  3/189 (1.59%)  0/175 (0.00%) 
Metastases To Meninges  1  0/189 (0.00%)  1/175 (0.57%) 
Tumour Pain  1  0/189 (0.00%)  1/175 (0.57%) 
Nervous system disorders     
Brain Oedema  1  0/189 (0.00%)  1/175 (0.57%) 
Cerebral Infarction  1  1/189 (0.53%)  0/175 (0.00%) 
Dizziness  1  2/189 (1.06%)  0/175 (0.00%) 
Epilepsy  1  1/189 (0.53%)  0/175 (0.00%) 
Ischaemic Stroke  1  0/189 (0.00%)  1/175 (0.57%) 
Paraesthesia  1  2/189 (1.06%)  0/175 (0.00%) 
Paraparesis  1  0/189 (0.00%)  1/175 (0.57%) 
Seizure  1  0/189 (0.00%)  1/175 (0.57%) 
Spinal Cord Compression  1  0/189 (0.00%)  1/175 (0.57%) 
Psychiatric disorders     
Anxiety  1  1/189 (0.53%)  0/175 (0.00%) 
Disorientation  1  1/189 (0.53%)  0/175 (0.00%) 
Gastrointestinal Somatic Symptom Disorder  1  0/189 (0.00%)  1/175 (0.57%) 
Renal and urinary disorders     
Acute Kidney Injury  1  0/189 (0.00%)  1/175 (0.57%) 
Renal Tubular Disorder  1  0/189 (0.00%)  1/175 (0.57%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1  0/189 (0.00%)  1/175 (0.57%) 
Alveolitis Allergic  1  0/189 (0.00%)  1/175 (0.57%) 
Dyspnoea  1  5/189 (2.65%)  8/175 (4.57%) 
Epistaxis  1  1/189 (0.53%)  0/175 (0.00%) 
Haemoptysis  1  0/189 (0.00%)  3/175 (1.71%) 
Hypoxia  1  0/189 (0.00%)  1/175 (0.57%) 
Pleural Effusion  1  7/189 (3.70%)  5/175 (2.86%) 
Pleuritic Pain  1  0/189 (0.00%)  1/175 (0.57%) 
Pneumonia Aspiration  1  0/189 (0.00%)  1/175 (0.57%) 
Pneumonitis  1  1/189 (0.53%)  0/175 (0.00%) 
Pneumothorax  1  1/189 (0.53%)  1/175 (0.57%) 
Pulmonary Artery Thrombosis  1  0/189 (0.00%)  1/175 (0.57%) 
Pulmonary Embolism  1  3/189 (1.59%)  6/175 (3.43%) 
Respiratory Arrest  1  0/189 (0.00%)  1/175 (0.57%) 
Respiratory Failure  1  1/189 (0.53%)  4/175 (2.29%) 
Skin and subcutaneous tissue disorders     
Eczema  1  1/189 (0.53%)  0/175 (0.00%) 
Psoriasis  1  1/189 (0.53%)  0/175 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis  1  1/189 (0.53%)  1/175 (0.57%) 
Embolism  1  0/189 (0.00%)  1/175 (0.57%) 
Hypotension  1  1/189 (0.53%)  0/175 (0.00%) 
Peripheral Artery Occlusion  1  0/189 (0.00%)  1/175 (0.57%) 
Superior Vena Cava Syndrome  1  0/189 (0.00%)  2/175 (1.14%) 
Venous Thrombosis Limb  1  0/189 (0.00%)  1/175 (0.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ceritinib Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   186/189 (98.41%)   166/175 (94.86%) 
Blood and lymphatic system disorders     
Anaemia  1  28/189 (14.81%)  60/175 (34.29%) 
Leukopenia  1  6/189 (3.17%)  15/175 (8.57%) 
Neutropenia  1  9/189 (4.76%)  38/175 (21.71%) 
Thrombocytopenia  1  3/189 (1.59%)  17/175 (9.71%) 
Ear and labyrinth disorders     
Tinnitus  1  4/189 (2.12%)  16/175 (9.14%) 
Gastrointestinal disorders     
Abdominal Distension  1  15/189 (7.94%)  4/175 (2.29%) 
Abdominal Pain  1  47/189 (24.87%)  13/175 (7.43%) 
Abdominal Pain Upper  1  38/189 (20.11%)  10/175 (5.71%) 
Constipation  1  36/189 (19.05%)  38/175 (21.71%) 
Diarrhoea  1  160/189 (84.66%)  17/175 (9.71%) 
Dyspepsia  1  16/189 (8.47%)  9/175 (5.14%) 
Nausea  1  128/189 (67.72%)  96/175 (54.86%) 
Stomatitis  1  10/189 (5.29%)  19/175 (10.86%) 
Vomiting  1  122/189 (64.55%)  59/175 (33.71%) 
General disorders     
Asthenia  1  32/189 (16.93%)  36/175 (20.57%) 
Face Oedema  1  2/189 (1.06%)  10/175 (5.71%) 
Fatigue  1  55/189 (29.10%)  51/175 (29.14%) 
Non-Cardiac Chest Pain  1  36/189 (19.05%)  17/175 (9.71%) 
Oedema Peripheral  1  10/189 (5.29%)  26/175 (14.86%) 
Pyrexia  1  33/189 (17.46%)  20/175 (11.43%) 
Infections and infestations     
Influenza  1  11/189 (5.82%)  9/175 (5.14%) 
Nasopharyngitis  1  12/189 (6.35%)  9/175 (5.14%) 
Upper Respiratory Tract Infection  1  18/189 (9.52%)  15/175 (8.57%) 
Investigations     
Alanine Aminotransferase Increased  1  113/189 (59.79%)  38/175 (21.71%) 
Amylase Increased  1  19/189 (10.05%)  9/175 (5.14%) 
Aspartate Aminotransferase Increased  1  98/189 (51.85%)  34/175 (19.43%) 
Blood Alkaline Phosphatase Increased  1  55/189 (29.10%)  8/175 (4.57%) 
Blood Bilirubin Increased  1  11/189 (5.82%)  1/175 (0.57%) 
Blood Creatinine Increased  1  42/189 (22.22%)  17/175 (9.71%) 
Creatinine Renal Clearance Decreased  1  13/189 (6.88%)  6/175 (3.43%) 
Electrocardiogram Qt Prolonged  1  21/189 (11.11%)  2/175 (1.14%) 
Gamma-Glutamyltransferase Increased  1  70/189 (37.04%)  18/175 (10.29%) 
Haemoglobin Decreased  1  6/189 (3.17%)  11/175 (6.29%) 
Neutrophil Count Decreased  1  4/189 (2.12%)  26/175 (14.86%) 
Platelet Count Decreased  1  4/189 (2.12%)  10/175 (5.71%) 
Weight Decreased  1  45/189 (23.81%)  26/175 (14.86%) 
White Blood Cell Count Decreased  1  7/189 (3.70%)  31/175 (17.71%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  64/189 (33.86%)  55/175 (31.43%) 
Hyperglycaemia  1  20/189 (10.58%)  12/175 (6.86%) 
Hypokalaemia  1  10/189 (5.29%)  8/175 (4.57%) 
Hyponatraemia  1  11/189 (5.82%)  11/175 (6.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  18/189 (9.52%)  17/175 (9.71%) 
Back Pain  1  35/189 (18.52%)  31/175 (17.71%) 
Musculoskeletal Chest Pain  1  12/189 (6.35%)  5/175 (2.86%) 
Musculoskeletal Pain  1  21/189 (11.11%)  11/175 (6.29%) 
Myalgia  1  7/189 (3.70%)  9/175 (5.14%) 
Pain In Extremity  1  20/189 (10.58%)  13/175 (7.43%) 
Nervous system disorders     
Dizziness  1  22/189 (11.64%)  17/175 (9.71%) 
Dysgeusia  1  17/189 (8.99%)  10/175 (5.71%) 
Headache  1  31/189 (16.40%)  21/175 (12.00%) 
Paraesthesia  1  10/189 (5.29%)  9/175 (5.14%) 
Psychiatric disorders     
Insomnia  1  17/189 (8.99%)  17/175 (9.71%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  46/189 (24.34%)  28/175 (16.00%) 
Dyspnoea  1  25/189 (13.23%)  28/175 (16.00%) 
Haemoptysis  1  10/189 (5.29%)  12/175 (6.86%) 
Oropharyngeal Pain  1  11/189 (5.82%)  6/175 (3.43%) 
Productive Cough  1  10/189 (5.29%)  8/175 (4.57%) 
Rhinorrhoea  1  10/189 (5.29%)  5/175 (2.86%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  9/189 (4.76%)  16/175 (9.14%) 
Pruritus  1  19/189 (10.05%)  8/175 (4.57%) 
Rash  1  28/189 (14.81%)  11/175 (6.29%) 
Vascular disorders     
Hypertension  1  2/189 (1.06%)  12/175 (6.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Among the 187 patients randomized to chemotherapy arm, 12 patients were not treated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01828099     History of Changes
Other Study ID Numbers: CLDK378A2301
2013-000319-26 ( EudraCT Number )
First Submitted: April 3, 2013
First Posted: April 10, 2013
Results First Submitted: June 23, 2017
Results First Posted: September 21, 2017
Last Update Posted: March 14, 2019