A late stage clinical trial to investigate the efficacy and safety of AZD9291 versus Gefitinib or Erlotinib in patients with locally advanced or metastatic Non-Small Cell Lung Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

1. Male or female, aged at least 18 years.
2. Pathologically confirmed adenocarcinoma of the lung.
3. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
4. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).
5. Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status.
6. Patients must be treatment-naïve for advanced NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 429
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 221

Exclusion Criteria

1. Treatment with any of the following:
-Prior treatment with any systemic anti-cancer therapy for advanced NSCLC.
- Prior treatment with an EGFR-TKI.
-Major surgery within 4 weeks of the first dose of study drug.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
-Patients currently receiving medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4.
- Treatment with an investigational drug within five half-lives of the compound or any of its related material.
2. Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug.
3. Spinal cord compression, symptomatic and unstable brain metastases, requiring steroids over the last 4 weeks prior to randomisation in this study.
4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
6. Any of the following cardiac criteria:
-Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
-Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
-Any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

A late stage clinical trial to investigate the efficacy and safety of AZD9291 versus Gefitinib or Erlotinib in patients with locally advanced or metastatic Non-Small Cell Lung Cancer

Recruitment & Eligibility

Study & Design

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