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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 : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: AZD9291 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 11, 2014
Actual Primary Completion Date : March 4, 2016
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Arm Intervention/treatment
Experimental: AZD9291
Once daily tablet 80 mg
Drug: AZD9291
Once daily tablet 80 mg




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442349


Locations
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Australia
Research Site
Kogarah, Australia, 2217
Research Site
Perth, Australia, WA 6009
Research Site
Woolloongabba, Australia, 4102
China
Research Site
Beijing, China, 100021
Research Site
Beijing, China, 100142
Research Site
Beijing, China, 100730
Research Site
Changchun, China, 130012
Research Site
Chengdu, China, 610041
Research Site
Chongqing, China, 400038
Research Site
Chongqin, China, 400042
Research Site
Fuzhou, China, 350014
Research Site
Haikou, China, 570311
Research Site
Hangzhou, China, 310003
Research Site
Hangzhou, China, 310006
Research Site
Hangzhou, China, 310022
Research Site
Harbin, China, 150049
Research Site
Jinan, China, 2501117
Research Site
Nanjing, China, 210009
Research Site
Shanghai, China, 200030
Research Site
Shanghai, China, 200032
Research Site
Shanghai, China, CN-200433
Research Site
Wuhan, China, 430022
Research Site
Wuhan, China, 430030
Research Site
Xi'an, China, 710032
Research Site
Xi'an, China, 710038
Research Site
Zhengzhou, China, 450008
Korea, Republic of
Research Site
Goyang-si, Korea, Republic of, 10408
Research Site
Seongnam-si, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02442349    
Other Study ID Numbers: D5160C00017
First Posted: May 13, 2015    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: March 19, 2020
Last Verified: March 2020
Keywords provided by AstraZeneca:
Phase II, Open Label, Single-arm study, Safety and Efficacy of AZD9291, Asia Pacific, NSCLC with T790M mutation within the Epidermal Growth Factor Receptor Gene
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action