Phase II Single Arm study of AZD9291 to treat NSCLC patients in Asia Pacific - AURA17

Study identifier:D5160C00017

ClinicalTrials.gov identifier:NCT02442349

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

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.

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 2

Healthy volunteers

Study drug

AZD9291

Sex

All

Actual Enrollment

171

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 22 Jun 2015

Primary Completion Date: 04 Mar 2016

Estimated Study Completion Date: 29 Dec 2023

Study design

Allocation: N/A
Endpoint Classification: Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2023 by AstraZeneca

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: AZD9291 Once daily tablet 80 mg	Drug: AZD9291 Once daily tablet 80 mg

Documents available

Redacted CSP
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]