Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 13, 2015
Results First Submitted Date  ICMJE January 13, 2017
Results First Posted Date  ICMJE April 25, 2017
Last Update Posted Date December 2, 2021
Actual Study Start Date  ICMJE June 22, 2015
Actual Primary Completion Date March 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
Objective Response Rate (ORR) According to RECIST 1.1 [ 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). ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
ORR according to RECIST 1.1 [ Time Frame: At baseline and every 6 weeks from time of first dose until objective disease progression, for an average of approximately 12 months. ]
To assess the efficacy of AZD9291 by assessment of Objective Response Rate (ORR) by Independent Central Review (ICR).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
Disease Control Rate (DCR) According to RECIST 1.1 [ 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). ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • PFS according to RECIST 1.1 [ Time Frame: At baseline and every 6 weeks from time of first dose until objective disease progression, for an average of approximately 12 months. ]
    To assess the efficacy of AZD9291 regarding Progression Free Survival.
  • Patient Reported Outcomes by EORTC QLQ-C30 questionnaire [ Time Frame: Questionnaires completed at baseline, every 6 weeks relative to first dose, discontinuation and during the progression and survival follow-up periods for approximately 2 years. ]
    To assess the impact of AZD9291 on patients' disease-related symptoms and health related quality of life (HRQoL).
  • Overall Survival (OS) [ Time Frame: From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks up to approximately 60 months. ]
    To assess the efficacy of AZD9291 regarding overall survival.
  • DoR according to RECIST 1.1 [ Time Frame: At baseline and every 6 weeks from time first dose until date of progression, for an average of approximately 12 months. ]
    To assess the efficacy of AZD9291 regarding During of response (DoR).
  • DCR according to RECIST 1.1 [ Time Frame: At baseline and every 6 weeks from time first dose until date of progression, for an average of approximately 12 months. ]
    To assess the efficacy of AZD9291 regarding Disease Control Rate (DCR).
  • Tumour shrinkage according to RECIST 1.1 [ Time Frame: At baseline and every 6 weeks from time of first dose until date of progression, for an average of approximately 12 months. ]
    To assess the efficacy of AZD9291 regarding tumour shrinkage.
  • Patient Reported Outcomes by EORTC QLQ LC13 questionnaire [ Time Frame: Questionnaires completed at baseline, weekly for the first 3 weeks, then every 3 weeks (relative to first dose), discontinuation and during the progression and survival follow-up periods for approximately 2 years. ]
    To assess the impact of AZD9291 on patients' disease-related symptoms and health related quality of life (HRQoL).
  • Safety and tolerability profile of AZD9291. [ Time Frame: Adverse events will be collected from baseline until 28 days after the last dose, expected average 12 months. ]
    To assess by number and severity of adverse events as recorded on the case report form, clinical chemistry, haematology, urinalysis, vital signs, physical examination, weight, ECG and WHO Performance Status.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific
Official Title  ICMJE A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia Pacific Patients With Locally Advanced/Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene.
Brief Summary A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene
Detailed Description This is a phase II, open label, single arm study assessing the safety and efficacy of AZD9291 (80 mg, orally, once daily) in Asia Pacific patients with a confirmed diagnosis of Epidermal Growth Factor Receptor (EGFR) sensitising mutation positive (ie, G719X, exon 19 deletion, L858R, L861Q) and T790M mutation positive (hereafter referred to as EGFRm+ and T790M+) un-resectable, locally advanced or metastatic NSCLC (Stage IIIB-IV), who have progressed on an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor(EGFR-TKI), either as first line treatment or following one line of EGFR-TKI and one line of platinum containing doublet chemotherapy. Patients must agree to provide a biopsy for central confirmation of T790M mutation status following confirmed disease progression on the most recent treatment regimen. The primary objective of the study is to assess the efficacy of AZD9291 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: AZD9291
Once daily tablet 80 mg
Study Arms  ICMJE Experimental: AZD9291
Once daily tablet 80 mg
Intervention: Drug: AZD9291
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 4, 2017)
171
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
175
Estimated Study Completion Date  ICMJE December 30, 2022
Actual Primary Completion Date March 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged at least 18 years. Patient from Asia Pacific will be enrolled only.
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
  • Radiological documentation of disease progression on the last treatment administered prior to enrolling in the study: following 1st line EGFR TKI treatment but who have not received further treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. Patients may have also received additional lines of treatment.
  • Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).
  • Patients must have central confirmation of tumour T790M mutation positive status from a biopsy sample taken after confirmation of disease progression on the most recent treatment regimen.
  • World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
  • At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
  • Females of child-bearing potential using contraception and must have a negative pregnancy test.

Exclusion Criteria:

  • Treatment with an EGFR-TKI (eg, erlotinib, gefitinib, icotinib or afatinib) within 8 days or approximately 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with AZD9291 or a 3rd generation EGFR TKIs; Major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of study entry; currently receiving treatment with potent inhibitors or inducers of CYP3A4.
  • Any unresolved toxicities from prior therapy.
  • Unstable spinal cord compression or brain metastases.
  • Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or infection.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.
  • Cardiac disease.
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Inadequate bone marrow reserve or organ function.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   China,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02442349
Other Study ID Numbers  ICMJE D5160C00017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP