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Clinical Trials List

Protocol NumberD5160C00003

2014-08-01 - 2024-10-17

Phase III

Study ended11

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or 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 (AURA3)

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator 何明霖 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator 賴瑞生 Division of Thoracic Medicine
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator 柯政昌 Division of Thoracic Medicine
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Condition/Disease

Non-small cell lung cancer

Objectives

Primary objectives To assess the efficacy of AZD9291 compared with platinum-based doublet chemotherapy by assessment of Progression Free Survival (PFS) Secondary objectives To further assess the efficacy of AZD9291 compared with platinum-based doublet chemotherapy in terms of: - Objective Response Rate (ORR) - Duration of Response (DoR) - Disease Control Rate (DCR) - Tumour shrinkage - Overall Survival (OS) To assess the effect of AZD9291 compared to platinum-based doublet chemotherapy on subjects’ disease-related symptoms and health related quality of life (HRQoL). To characterise the pharmacokinetics (PK) of AZD9291 and metabolites in subjects receiving AZD9291.

Test Drug

AZD9291

Active Ingredient

AZD9291 mesylate

Dosage Form

Tablet

Dosage

40/80

Endpoints

1. Primary efficacy variable:
Progression Free Survival (PFS) using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
2. Secondary efficacy variables:
ORR, DoR, DCR and tumour shrinkage using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Analysis of overall survival.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Lung Cancer 13 items (EORTC QLQ-LC13).
The EQ-5D-5L health state utility index will be used to derive health state utility based on subject reported data.
3. To assess the safety and tolerability profile of AZD9291 compared with platinumbased doublet chemotherapy.
Adverse events (graded by CTCAE v4)
- Clinical chemistry, haematology and urinalysis
- Vital signs (pulse and BP), Physical
Examination, Weight
- Central Digital ECG
- Echocardiogram/MUGA (for LVEF)
- WHO performance status

Inclution Criteria

* Subjects with histologically- or cytologically-documented NSCLC.
* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
* Evidence of radiological disease progression following 1st line EGFR TKI (ie 1st line treatment for advanced/metastatic disease) without any further treatment.
* Subjects must have a diagnosis of “Nonsquamous Non-Small Cell Lung Cancer” in order
to be eligible to receive treatment with pemetrexed platinum-based doublet chemotherapy
in accordance with local prescribing information.
*Subjects must have central confirmation of tumour T790M+ mutation status from a tissue
biopsy sample taken after documented disease progression on first line treatment with an
approved.
*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.

Exclusion Criteria

* Treatment with more than one prior line of treatment for advanced NSCLC.
* Treatment with an EGFR-TKI (e.g., erlotinib, gefitinib or afatinib) within 8 days or
approximately 5x half-life, whichever is the longer, of the first dose of study treatment. (If sufficient washout time has not occurred due to schedule or PK properties, an alternative appropriate washout time based on known duration and time to reversibility of drug related adverse events could be agreed upon by AstraZeneca and the Investigator)
* Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from
a previous treatment regimen or clinical study within 14 days of randomization.
* Previous treatment with AZD9291, or a 3rd generation EGFR TKI

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    610 participants

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