Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (AURA3)

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: NCT02151981
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Results First Posted : July 21, 2017
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anticancer Treatment
Interventions Drug: Chemotherapy
Drug: Cross-over to Osimertinib
Enrollment 419
Recruitment Details First patient dosed: 20 August 2014. Data cut off: 15 March 2019. Open for enrolment at 145 study centres, 126 centres in 17 countries randomised patients to treatment. Following the final OS analysis, patients were permitted to continue to receive treatment if, in the investigator's opinion, they were continuing to receive benefit from treatment.
Pre-assignment Details  
Arm/Group Title Osimertinib 80 mg Chemotherapy
Hide Arm/Group Description Daily single dose of Osimertinib 80mg Platinum-based doublet chemotherapy
Period Title: Overall Study
Started 279 140
Received Randomised Treatment Only 279 136
Did Not Receive Treatment 0 4
Crossed Over Osimertinib 0 99 [1]
Completed 0 0
Not Completed 279 140
Reason Not Completed
Death             184             88
Lost to Follow-up             7             1
Withdrawal by Subject             27             21
Ongoing Study at Data Cut-off             60             27
Eligibility criteria not fulfilled             0             1
Patient had no clinical benefit             1             0
Unwilling to continue to follow up visit             0             1
Study terminated             0             1
[1]
Patients randomised to chemotherapy were allowed to crossover to Osimertinib after progression
Arm/Group Title Osimertinib 80 mg Chemotherapy Total
Hide Arm/Group Description Daily single dose of Osimertinib 80mg Platinum-based doublet chemotherapy Total of all reporting groups
Overall Number of Baseline Participants 279 140 419
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 279 participants 140 participants 419 participants
61.5  (11.64) 62.0  (11.91) 61.7  (11.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants 140 participants 419 participants
Female
172
  61.6%
97
  69.3%
269
  64.2%
Male
107
  38.4%
43
  30.7%
150
  35.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants 140 participants 419 participants
Asian
182
  65.2%
92
  65.7%
274
  65.4%
Black Or African American
4
   1.4%
1
   0.7%
5
   1.2%
Other
4
   1.4%
1
   0.7%
5
   1.2%
White
89
  31.9%
45
  32.1%
134
  32.0%
American Indian or Alaska Native
0
   0.0%
1
   0.7%
1
   0.2%
1.Primary Outcome
Title Progression Free Survival (PFS) by Investigator Assessment
Hide Description Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
Time Frame RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (All randomised patients)
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 279 140
Overall Number of Units Analyzed
Type of Units Analyzed: Events
140 110
Median (95% Confidence Interval)
Unit of Measure: Months
10.1
(8.3 to 12.3)
4.4
(4.2 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.23 to 0.41
Estimation Comments A hazard ratio <1 favours Osimertinib 80mg
2.Secondary Outcome
Title Objective Response Rate (ORR) by Investigator Assessment
Hide Description Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.
Time Frame RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (All randomised patients)
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 279 140
Measure Type: Number
Unit of Measure: % of participants
70.6 31.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments adjusted for ethnicity (Asian/non-Asian)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.39
Confidence Interval (2-Sided) 95%
3.47 to 8.48
Estimation Comments odds ratio >1.0 favours Osimertinib 80 mg
3.Secondary Outcome
Title Duration of Response (DoR) by Investigator Assessment
Hide Description Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Time Frame RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (All randomised patients)
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 279 140
Median (95% Confidence Interval)
Unit of Measure: months
9.7
(8.3 to 11.6)
4.1
(3.0 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method formulae provided in Ellis S et al 2008
Comments Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients
Method of Estimation Estimation Parameter Ratio of Expected (DoR)
Estimated Value 6.22
Confidence Interval (2-Sided) 95%
4.04 to 9.57
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Disease Control Rate (DCR) by Investigator Assessment
Hide Description Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD at >=6 weeks, prior to any progressive disease (PD).
Time Frame RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (All randomised patients)
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 279 140
Measure Type: Number
Unit of Measure: % of participants
93.2 74.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.76
Confidence Interval (2-Sided) 95%
2.64 to 8.84
Estimation Comments odds ratio >1.0 favours Osimertinib 80 mg
5.Secondary Outcome
Title Tumour Shrinkage by Investigator Assessment
Hide Description Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response.
Time Frame RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (All randomised patients)
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 278 131
Mean (Standard Deviation)
Unit of Measure: % change from baseline
-46.1  (29.50) -24.4  (29.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions
Method of Estimation Estimation Parameter Difference in LS means
Estimated Value -21.62
Confidence Interval (2-Sided) 95%
-27.71 to -15.52
Estimation Comments LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means <0 favours Osimertinib 80mg
6.Secondary Outcome
Title Secondary: Overall Survival (OS)
Hide Description [Not Specified]
Time Frame From date of randomization until time of final OS analysis, a median follow-up of 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 279 140
Median (95% Confidence Interval)
Unit of Measure: Months
26.8
(23.5 to 31.5)
22.5
(20.2 to 28.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.67 to 1.13
Estimation Comments A hazard ratio <1 favours Osimertinib 80 mg
7.Other Pre-specified Outcome
Title Time to First Subsequent Therapy (TFST)
Hide Description Time from randomisation to first subsequent anti-cancer therapy (FST) following randomised treatment discontinuation, or death if no FST administered. Any patient not known to have died nor received any subsequent anti-cancer therapy (ST) was censored at the last time known not to have received ST, ie, the last follow-up visit this was confirmed.
Time Frame From date of randomisation until time of final OS analysis, a median follow-up of 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (All randomised patients)
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 279 140
Median (95% Confidence Interval)
Unit of Measure: Months
16.0
(13.8 to 18.4)
6.0
(5.2 to 6.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.16 to 0.28
Estimation Comments A hazard ratio <1 favors Osimertinib 80mg
8.Other Pre-specified Outcome
Title Time to Second Subsequent Therapy (TSST)
Hide Description Time from randomisation to second subsequent anti-cancer therapy (SST) following randomised treatment discontinuation, or death if no SST administered. Any patient not known to have died nor received any SST was censored at the last time known not to have received SST, ie, the last follow-up visit this was confirmed.
Time Frame From date of randomisation until time of final OS analysis, a median follow-up of 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (All randomised patients)
Arm/Group Title Osimertinib 80mg Chemotherapy
Hide Arm/Group Description:
Daily single dose of Osimertinib 80mg
Platinum-based doublet chemotherapy
Overall Number of Participants Analyzed 279 140
Median (95% Confidence Interval)
Unit of Measure: Months
20.0
(17.2 to 23.2)
19.0
(16.5 to 22.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Osimertinib 80mg, Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.69 to 1.11
Estimation Comments A hazard ratio <1 favours Osimertinib 80 mg
Time Frame AEs from start of study drug until 28 days post treatment discontinuation up to 4 years and 7 months (at the time of analysis)
Adverse Event Reporting Description Systematic assessment due to regular investigator assessment at study visits.
 
Arm/Group Title Osimertinib 80 mg Chemotherapy
Hide Arm/Group Description Daily single dose of Osimertinib 80mg Platinum-based doublet chemotherapy
All-Cause Mortality
Osimertinib 80 mg Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   188/279 (67.38%)      93/136 (68.38%)    
Hide Serious Adverse Events
Osimertinib 80 mg Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   84/279 (30.11%)      36/136 (26.47%)    
Blood and lymphatic system disorders     
Anaemia  1  1/279 (0.36%)  1 3/136 (2.21%)  3
Disseminated intravascular coagulation  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Febrile neutropenia  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Leukocytosis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Leukopenia  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Neutropenia  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Cardiac disorders     
Angina pectoris  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Atrial fibrillation  1  2/279 (0.72%)  2 1/136 (0.74%)  1
Cardiac failure  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Pericardial effusion  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Atrial thrombosis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Cardiac tamponade  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  1/279 (0.36%)  1 1/136 (0.74%)  1
Gastrointestinal disorders     
Intestinal ischaemia  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Ascites  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Diarrhoea  1  1/279 (0.36%)  2 1/136 (0.74%)  1
Gastrointestinal disorder  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Nausea  1  2/279 (0.72%)  2 2/136 (1.47%)  3
Vomiting  1  4/279 (1.43%)  4 1/136 (0.74%)  1
Abdominal pain  1  1/279 (0.36%)  1 1/136 (0.74%)  1
Dental caries  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Ileus  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Large intestine polyp  1  1/279 (0.36%)  1 0/136 (0.00%)  0
General disorders     
Asthenia  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Chest discomfort  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Non-cardiac chest pain  1  1/279 (0.36%)  1 2/136 (1.47%)  2
Pyrexia  1  2/279 (0.72%)  2 2/136 (1.47%)  2
General physical health deterioratio  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Hepatitis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Immune system disorders     
Contrast media allergy  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Infections and infestations     
Pneumonia  1  6/279 (2.15%)  6 0/136 (0.00%)  0
Bronchiolitis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Cellulitis  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Enterocolitis infectious  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Gastroenteritis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Hepatitis B  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Herpes zoster  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Lung infection  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Pneumonia bacterial  1  1/279 (0.36%)  1 1/136 (0.74%)  1
Tuberculosis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Urosepsis  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Bacterial infection  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Gastroenteritis viral  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Periodontitis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Respiratory tract infection  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Sepsis  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Upper respiratory tract infection  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Urinary tract infection  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Injury, poisoning and procedural complications     
Hip fracture  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Road traffic accident  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Subdural haematoma  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Pharynx radiation injury  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Investigations     
Electrocardiogram QT prolonged  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Fibrin D dimer increased  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Haemoglobin decreased  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Blood bilirubin increased  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  0/279 (0.00%)  0 2/136 (1.47%)  2
Diabetes mellitus inadequate control  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Hypoglycaemia  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Dehydration  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Hyperuricaemia  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Hyponatraemia  1  1/279 (0.36%)  2 0/136 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Flank pain  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Muscular weakness  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Musculoskeletal chest pain  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Osteoarthritis  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Osteonecrosis of jaw  1  1/279 (0.36%)  4 0/136 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Invasive breast carcinoma  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Nervous system disorders     
Epilepsy  1  0/279 (0.00%)  0 3/136 (2.21%)  3
Seizure  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Cerebral infarction  1  3/279 (1.08%)  3 1/136 (0.74%)  1
Embolic stroke  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Headache  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Ischaemic stroke  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Spinal cord compression  1  1/279 (0.36%)  1 1/136 (0.74%)  1
Cerebrovascular accident  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Sciatica  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Transient ischaemic attack  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Psychiatric disorders     
Bipolar disorder  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Psychiatric decompensation  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Anxiety  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Organic brain syndrome  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Haematuria  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Reproductive system and breast disorders     
Uterine cyst  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Lung consolidation  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Pneumonitis  1  2/279 (0.72%)  2 1/136 (0.74%)  1
Dyspnoea  1  4/279 (1.43%)  4 0/136 (0.00%)  0
Interstitial lung disease  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Pleural effusion  1  2/279 (0.72%)  2 0/136 (0.00%)  0
Pneumothorax  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Pulmonary embolism  1  8/279 (2.87%)  8 2/136 (1.47%)  2
Respiratory failure  1  3/279 (1.08%)  3 0/136 (0.00%)  0
Dyspnoea exertional  1  1/279 (0.36%)  1 0/136 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/279 (0.36%)  1 4/136 (2.94%)  4
Hypovolaemic shock  1  0/279 (0.00%)  0 1/136 (0.74%)  1
Peripheral arterial occlusive disease  1  1/279 (0.36%)  1 0/136 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Osimertinib 80 mg Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   275/279 (98.57%)      134/136 (98.53%)    
Blood and lymphatic system disorders     
Anaemia  1  32/279 (11.47%)  38 35/136 (25.74%)  45
Leukopenia  1  14/279 (5.02%)  33 7/136 (5.15%)  12
Neutropenia  1  14/279 (5.02%)  24 17/136 (12.50%)  26
Thrombocytopenia  1  18/279 (6.45%)  30 10/136 (7.35%)  15
Ear and labyrinth disorders     
Tinnitus  1  2/279 (0.72%)  2 7/136 (5.15%)  7
Eye disorders     
Lacrimation increased  1  1/279 (0.36%)  1 8/136 (5.88%)  10
Gastrointestinal disorders     
Abdominal pain upper  1  10/279 (3.58%)  13 11/136 (8.09%)  11
Constipation  1  50/279 (17.92%)  56 48/136 (35.29%)  94
Diarrhoea  1  123/279 (44.09%)  226 14/136 (10.29%)  21
Nausea  1  64/279 (22.94%)  75 66/136 (48.53%)  144
Stomatitis  1  48/279 (17.20%)  70 22/136 (16.18%)  26
Vomiting  1  42/279 (15.05%)  53 27/136 (19.85%)  49
Abdominal pain  1  20/279 (7.17%)  22 6/136 (4.41%)  9
Dyspepsia  1  15/279 (5.38%)  18 2/136 (1.47%)  2
Mouth ulceration  1  16/279 (5.73%)  26 0/136 (0.00%)  0
General disorders     
Asthenia  1  23/279 (8.24%)  29 19/136 (13.97%)  25
Fatigue  1  54/279 (19.35%)  66 40/136 (29.41%)  60
Malaise  1  12/279 (4.30%)  14 14/136 (10.29%)  21
Non-cardiac chest pain  1  23/279 (8.24%)  24 6/136 (4.41%)  6
Oedema peripheral  1  16/279 (5.73%)  21 16/136 (11.76%)  23
Pyrexia  1  29/279 (10.39%)  36 13/136 (9.56%)  15
Infections and infestations     
Nasopharyngitis  1  34/279 (12.19%)  45 7/136 (5.15%)  7
Paronychia  1  58/279 (20.79%)  72 2/136 (1.47%)  2
Upper respiratory tract infection  1  36/279 (12.90%)  61 10/136 (7.35%)  10
Urinary tract infection  1  24/279 (8.60%)  32 6/136 (4.41%)  9
Conjunctivitis  1  14/279 (5.02%)  17 5/136 (3.68%)  6
Investigations     
Alanine aminotransferase increased  1  23/279 (8.24%)  34 17/136 (12.50%)  25
Aspartate aminotransferase increased  1  21/279 (7.53%)  33 16/136 (11.76%)  23
Blood creatinine increased  1  16/279 (5.73%)  20 9/136 (6.62%)  15
Neutrophil count decreased  1  17/279 (6.09%)  31 16/136 (11.76%)  38
Platelet count decreased  1  20/279 (7.17%)  32 21/136 (15.44%)  34
Weight decreased  1  16/279 (5.73%)  17 7/136 (5.15%)  7
White blood cell count decreased  1  22/279 (7.89%)  38 12/136 (8.82%)  36
Metabolism and nutrition disorders     
Decreased appetite  1  67/279 (24.01%)  78 49/136 (36.03%)  87
Hypoalbuminaemia  1  4/279 (1.43%)  6 7/136 (5.15%)  9
Musculoskeletal and connective tissue disorders     
Arthralgia  1  25/279 (8.96%)  30 7/136 (5.15%)  8
Back pain  1  42/279 (15.05%)  52 14/136 (10.29%)  20
Musculoskeletal chest pain  1  21/279 (7.53%)  25 8/136 (5.88%)  8
Pain in extremity  1  25/279 (8.96%)  31 6/136 (4.41%)  11
Muscle spasms  1  19/279 (6.81%)  22 2/136 (1.47%)  2
Musculoskeletal pain  1  21/279 (7.53%)  27 4/136 (2.94%)  4
Nervous system disorders     
Dizziness  1  22/279 (7.89%)  26 12/136 (8.82%)  16
Dysgeusia  1  9/279 (3.23%)  9 12/136 (8.82%)  13
Headache  1  33/279 (11.83%)  44 16/136 (11.76%)  19
Psychiatric disorders     
Insomnia  1  26/279 (9.32%)  28 14/136 (10.29%)  16
Respiratory, thoracic and mediastinal disorders     
Cough  1  60/279 (21.51%)  72 20/136 (14.71%)  21
Dyspnoea  1  35/279 (12.54%)  40 18/136 (13.24%)  20
Epistaxis  1  20/279 (7.17%)  21 3/136 (2.21%)  3
Productive cough  1  18/279 (6.45%)  20 3/136 (2.21%)  3
Rhinorrhoea  1  14/279 (5.02%)  18 2/136 (1.47%)  2
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  41/279 (14.70%)  70 3/136 (2.21%)  3
Dry skin  1  54/279 (19.35%)  66 6/136 (4.41%)  6
Pruritus  1  42/279 (15.05%)  55 7/136 (5.15%)  9
Rash maculo-papular  1  19/279 (6.81%)  25 3/136 (2.21%)  3
Skin fissures  1  16/279 (5.73%)  18 1/136 (0.74%)  1
Vascular disorders     
Hypertension  1  9/279 (3.23%)  10 10/136 (7.35%)  11
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review, should the submission for publication be delayed in order to file patent application. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Lead
Organization: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02151981    
Other Study ID Numbers: D5160C00003
First Submitted: May 15, 2014
First Posted: June 2, 2014
Results First Submitted: April 12, 2017
Results First Posted: July 21, 2017
Last Update Posted: May 3, 2021