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Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours (AURA2)

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ClinicalTrials.gov Identifier: NCT02094261
Recruitment Status : Active, not recruiting
First Posted : March 21, 2014
Results First Posted : June 7, 2016
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Intervention Drug: AZD9291
Enrollment 210
Recruitment Details First patient enrolled: 28 April 2014, Data cut off: 1 May 2015. The study was open for enrolment at 44 study centres in Canada (3), Hong Kong (2), Italy (5), Japan (14), South Korea (3), Spain (6), Taiwan (2), and the USA (9). Recruitment has closed and primary analyses have been performed but study is still on-going.
Pre-assignment Details 472 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 262 patients were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 210 patients received treatment.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description Daily single dose of AZD9291 80mg
Period Title: Overall Study
Started 210
Completed 0
Not Completed 210
Reason Not Completed
Death             24
Lost to Follow-up             1
Withdrawal by Subject             4
Ongoing Study at Data Cut-off             181
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description Daily single dose of AZD9291 80mg
Overall Number of Baseline Participants 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants
62.9  (10.91)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 210 participants
<50 Years 20
>=50-<65 Years 88
>=65-<75 Years 69
>=75 Years 33
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
Female
146
  69.5%
Male
64
  30.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 210 participants
Asian 132
Black Or African American 3
Native Hawaiian Or Other Pacific Islander 1
Other 2
White 72
1.Primary Outcome
Title Objective Response Rate (ORR)
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 (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
Time Frame RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description:
Daily single dose of AZD9291 80mg
Overall Number of Participants Analyzed 199
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants
70.9
(64.0 to 77.1)
2.Secondary Outcome
Title Duration of Response (DoR)
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 was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
Time Frame RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description:
Daily single dose of AZD9291 80mg
Overall Number of Participants Analyzed 141
Median (Full Range)
Unit of Measure: months
7.8
(1.3 to 8.4)
3.Secondary Outcome
Title Disease Control Rate (DCR)
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 (according to independent review), prior to progression (PD) or further anti-cancer therapy.
Time Frame RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description:
Daily single dose of AZD9291 80mg
Overall Number of Participants Analyzed 199
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants
91.5
(86.7 to 94.9)
4.Secondary Outcome
Title Progression-Free Survival (PFS)
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 first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 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 first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of study treatment.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description:
Daily single dose of AZD9291 80mg
Overall Number of Participants Analyzed 210
Median (95% Confidence Interval)
Unit of Measure: months
8.6
(8.28 to 9.72)
Time Frame AEs from start of study drug until 28 days post treatment discontinuation, up to approximately 11 months (at time of analysis).
Adverse Event Reporting Description Systematic assessment due to regular investigator assessment at study visits.
 
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description Daily single dose of AZD9291 80mg
All-Cause Mortality
AZD9291 80mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
AZD9291 80mg
Affected / at Risk (%) # Events
Total   42/210 (20.00%)    
Blood and lymphatic system disorders   
Anaemia † 1  1/210 (0.48%)  1
Thrombocytopenia † 1  1/210 (0.48%)  1
Cardiac disorders   
Supraventricular tachycardia † 1  2/210 (0.95%)  2
Ear and labyrinth disorders   
Hearing impaired † 1  1/210 (0.48%)  1
Gastrointestinal disorders   
Abdominal pain † 1  1/210 (0.48%)  1
Gastritis † 1  1/210 (0.48%)  1
Small intestinal obstruction † 1  1/210 (0.48%)  1
General disorders   
Fatigue † 1  1/210 (0.48%)  1
Pyrexia † 1  1/210 (0.48%)  1
Hepatobiliary disorders   
Drug-induced liver injury † 1  1/210 (0.48%)  1
Infections and infestations   
Gastroenteritis † 1  1/210 (0.48%)  1
Influenza † 1  1/210 (0.48%)  1
Lung infection † 1  1/210 (0.48%)  1
Pharyngeal abscess † 1  1/210 (0.48%)  2
Pneumonia † 1  4/210 (1.90%)  5
Sepsis † 1  1/210 (0.48%)  1
Upper respiratory tract infection † 1  1/210 (0.48%)  1
Urinary tract infection † 1  1/210 (0.48%)  1
Injury, poisoning and procedural complications   
Radiation necrosis † 1  1/210 (0.48%)  1
Metabolism and nutrition disorders   
Dehydration † 1  1/210 (0.48%)  1
Failure to thrive † 1  1/210 (0.48%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain † 1  1/210 (0.48%)  1
Nervous system disorders   
Cerebral haemorrhage † 1  1/210 (0.48%)  1
Cerebral infarction † 1  2/210 (0.95%)  2
Headache † 1  1/210 (0.48%)  1
Transient ischaemic attack † 1  1/210 (0.48%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea † 1  1/210 (0.48%)  1
Interstitial lung disease † 1  2/210 (0.95%)  2
Pleurisy † 1  1/210 (0.48%)  1
Pneumonia aspiration † 1  1/210 (0.48%)  1
Pneumonitis † 1  1/210 (0.48%)  1
Pulmonary embolism † 1  8/210 (3.81%)  9
Vascular disorders   
Deep vein thrombosis † 1  2/210 (0.95%)  2
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD9291 80mg
Affected / at Risk (%) # Events
Total   193/210 (91.90%)    
Blood and lymphatic system disorders   
Anaemia † 1  19/210 (9.05%)  19
Thrombocytopenia † 1  11/210 (5.24%)  15
Eye disorders   
Dry eye † 1  11/210 (5.24%)  11
Gastrointestinal disorders   
Abdominal pain upper † 1  11/210 (5.24%)  14
Constipation † 1  32/210 (15.24%)  38
Diarrhoea † 1  81/210 (38.57%)  115
Nausea † 1  34/210 (16.19%)  35
Stomatitis † 1  22/210 (10.48%)  31
Vomiting † 1  16/210 (7.62%)  18
General disorders   
Asthenia † 1  11/210 (5.24%)  12
Fatigue † 1  31/210 (14.76%)  33
Oedema peripheral † 1  17/210 (8.10%)  18
Infections and infestations   
Nasopharyngitis † 1  21/210 (10.00%)  23
Paronychia † 1  32/210 (15.24%)  32
Upper respiratory tract infection † 1  11/210 (5.24%)  11
Urinary tract infection † 1  13/210 (6.19%)  16
Investigations   
Alanine aminotransferase increased † 1  15/210 (7.14%)  17
Aspartate aminotransferase increased † 1  12/210 (5.71%)  12
Electrocardiogram QT prolonged † 1  11/210 (5.24%)  13
Neutrophil count decreased † 1  14/210 (6.67%)  17
Platelet count decreased † 1  20/210 (9.52%)  23
White blood cell count decreased † 1  16/210 (7.62%)  22
Metabolism and nutrition disorders   
Decreased appetite † 1  29/210 (13.81%)  32
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  18/210 (8.57%)  19
Back pain † 1  25/210 (11.90%)  26
Muscle spasms † 1  11/210 (5.24%)  11
Musculoskeletal pain † 1  14/210 (6.67%)  15
Pain in extremity † 1  14/210 (6.67%)  14
Nervous system disorders   
Dizziness † 1  11/210 (5.24%)  11
Headache † 1  20/210 (9.52%)  25
Psychiatric disorders   
Insomnia † 1  11/210 (5.24%)  11
Respiratory, thoracic and mediastinal disorders   
Cough † 1  25/210 (11.90%)  31
Dyspnoea † 1  14/210 (6.67%)  16
Skin and subcutaneous tissue disorders   
Dermatitis acneiform † 1  16/210 (7.62%)  16
Dry skin † 1  52/210 (24.76%)  58
Pruritus † 1  32/210 (15.24%)  33
Rash † 1  49/210 (23.33%)  58
Rash maculo-papular † 1  14/210 (6.67%)  17
Skin fissures † 1  12/210 (5.71%)  18
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
[Not Specified]
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: Senior Medical Director, Tagrisso
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@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: NCT02094261    
Other Study ID Numbers: D5160C00002
First Submitted: March 17, 2014
First Posted: March 21, 2014
Results First Submitted: April 28, 2016
Results First Posted: June 7, 2016
Last Update Posted: February 23, 2021