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Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific (AURA17)

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: NCT02442349
Recruitment Status : Active, not recruiting
First Posted : May 13, 2015
Results First Posted : April 25, 2017
Last Update Posted : December 2, 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 171
Recruitment Details First patient enrolled: 22 June 2015, Data cut off: 04 March 2016. The study was open for enrollment at 31 study centres in China (24 sites), South Korea (4 sites), and Australia (3 sites). Recruitment has closed and primary analyses based on the data cut off of 04 March 2016 have been performed but study is still on-going.
Pre-assignment Details 319 signed informed consent from 306 patients (13 patients were re-screened). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 130 patients failed inclusion/exclusion criteria and 5 patients withdrew consent so were not eligible to be assigned treatment. Thus, 171 patients received treatment.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description Daily single dose of AZD9291 80mg
Period Title: Overall Study
Started 171
Completed 0
Not Completed 171
Reason Not Completed
Death             14
Withdrawal by Subject             8
On-going Study at Data Cut-off             149
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description Daily single dose of AZD9291 80mg
Overall Number of Baseline Participants 171
Hide Baseline Analysis Population Description
All patients enrolled who received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants
58.3  (10.81)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants
<50 Years 38
>=50-<65 Years 79
>=65-<75 Years 45
>=75 Years 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants
Female
117
  68.4%
Male
54
  31.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants
Asian 168
White 2
Other 1
1.Primary Outcome
Title Objective Response Rate (ORR) According to RECIST 1.1
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 time of first dose until objective disease progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).
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 by blinded independent central review (BICR) of baseline imaging data.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description:
Daily single dose of AZD9291 80mg
Overall Number of Participants Analyzed 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants
60.2
(52.37 to 67.74)
2.Secondary Outcome
Title Disease Control Rate (DCR) According to RECIST 1.1
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 time first dose until date of progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).
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 by blinded independent central review (BICR) of baseline imaging data.
Arm/Group Title AZD9291 80mg
Hide Arm/Group Description:
Daily single dose of AZD9291 80mg
Overall Number of Participants Analyzed 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants
88.0
(82.01 to 92.48)
Time Frame AEs from start of study drug until 28 days post treatment discontinuation, expected average 12 months. Results are based on the data cut off of 04 March 2016.
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   20/171 (11.70%)    
Cardiac disorders   
Cardiac failure  1  1/171 (0.58%)  1
Coronary artery disease  1  1/171 (0.58%)  1
Pericardial effusion  1  1/171 (0.58%)  1
Infections and infestations   
Bronchitis  1  1/171 (0.58%)  1
Gastroenteritis  1  1/171 (0.58%)  1
Infectious pleural effusion  1  1/171 (0.58%)  1
Lung infection  1  1/171 (0.58%)  1
Pneumonia  1  2/171 (1.17%)  2
Tuberculosis  1  1/171 (0.58%)  1
Upper respiratory tract infection  1  1/171 (0.58%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/171 (0.58%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm  1  1/171 (0.58%)  1
Lung neoplasm malignant  1  1/171 (0.58%)  1
Nervous system disorders   
Cerebral haemorrhage  1  1/171 (0.58%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchiectasis  1  1/171 (0.58%)  1
Chronic obstructive pulmonary disease  1  1/171 (0.58%)  1
Dyspnoea  1  2/171 (1.17%)  2
Haemoptysis  1  1/171 (0.58%)  1
Interstitial lung disease  1  1/171 (0.58%)  1
Respiratory failure  1  2/171 (1.17%)  2
Vascular disorders   
Deep vein thrombosis  1  1/171 (0.58%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD9291 80mg
Affected / at Risk (%) # Events
Total   135/171 (78.95%)    
Blood and lymphatic system disorders   
Leukopenia  1  22/171 (12.87%)  38
Neutropenia  1  16/171 (9.36%)  24
Gastrointestinal disorders   
Abdominal discomfort  1  9/171 (5.26%)  9
Diarrhoea  1  50/171 (29.24%)  122
Nausea  1  16/171 (9.36%)  19
Vomiting  1  14/171 (8.19%)  15
Infections and infestations   
Influenza  1  12/171 (7.02%)  17
Nasopharyngitis  1  14/171 (8.19%)  15
Paronychia  1  11/171 (6.43%)  11
Upper respiratory tract infection  1  11/171 (6.43%)  17
Urinary tract infection  1  10/171 (5.85%)  12
Investigations   
Neutrophil count decreased  1  12/171 (7.02%)  20
Platelet count decreased  1  19/171 (11.11%)  25
White blood cell count decreased  1  21/171 (12.28%)  29
Musculoskeletal and connective tissue disorders   
Back pain  1  12/171 (7.02%)  13
Pain in extremity  1  9/171 (5.26%)  9
Respiratory, thoracic and mediastinal disorders   
Cough  1  27/171 (15.79%)  31
Skin and subcutaneous tissue disorders   
Dry skin  1  24/171 (14.04%)  29
Pruritus  1  21/171 (12.28%)  31
Rash  1  13/171 (7.60%)  16
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Lead, Serban Ghiorghiu
Organization: AstraZeneca
Phone: +44 1625 512243
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02442349    
Other Study ID Numbers: D5160C00017
First Submitted: May 11, 2015
First Posted: May 13, 2015
Results First Submitted: January 13, 2017
Results First Posted: April 25, 2017
Last Update Posted: December 2, 2021