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Tyrosine Kinase Inhibitor

AZD9291 for Non-Small Cell Lung Cancer (ADAURA Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria
Must not have
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)
Pre-operative (neo-adjuvant) platinum based or other chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured by sf-36 questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug, AZD9291, to see if it is effective and safe in treating a certain type of lung cancer.

Who is the study for?
This trial is for adults over 18 with Stage IB-IIIA non-small cell lung cancer that's been surgically removed. They must have specific EGFR mutations, no major organ issues, and can't be on certain drugs or have had certain treatments. Women must not be pregnant and use birth control.
What is being tested?
The trial tests the effectiveness of AZD9291 (a targeted cancer drug) against a placebo in patients who've had surgery for lung cancer. Some may also receive standard chemotherapy. The goal is to see if AZD9291 improves outcomes post-surgery.
What are the potential side effects?
Possible side effects of AZD9291 include diarrhea, rash, dry skin, nail changes, mouth sores, reduced appetite, coughing up blood and potential heart rhythm problems (QTc prolongation). It might also cause liver enzyme elevation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is confirmed to be non-small cell and mostly not squamous.
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My cancer was classified as Stage IB, II, or IIIA after surgery.
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My tumor has EGFR mutations sensitive to treatment.
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I can perform most of my daily activities without help.
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My lung cancer was completely removed by surgery with no cancer cells at the edges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe illnesses, uncontrolled high blood pressure, active bleeding, or infections like hepatitis or HIV.
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I am receiving or have received chemotherapy before surgery.
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I am scheduled for, or have had, radiation therapy for my lung cancer.
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I haven't had major surgery, except for a vascular access procedure, in the last 4 weeks.
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I am not taking any strong CYP3A4 inducers.
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I have had a small part of my lung removed.
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I have had lung inflammation or damage that needed steroids.
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I cannot take pills due to severe nausea, vomiting, gut diseases, or major gut surgery.
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I have been treated with EGFR-TKI drugs before surgery or alongside other treatments.
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My bone marrow or organs are not functioning well.
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I have received treatment for cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured by sf-36 questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured by sf-36 questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Secondary study objectives
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Overall Survival (OS)
Overall Survival Rate at 2, 3 and 5 Years
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD9291Experimental Treatment2 Interventions
AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Group II: Placebo AZD9291Placebo Group1 Intervention
Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,378 Previous Clinical Trials
288,738,236 Total Patients Enrolled

Media Library

AZD9291 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02511106 — Phase 3
Lung Carcinoma Research Study Groups: Placebo AZD9291, AZD9291
Lung Carcinoma Clinical Trial 2023: AZD9291 Highlights & Side Effects. Trial Name: NCT02511106 — Phase 3
AZD9291 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02511106 — Phase 3
~68 spots leftby Oct 2025
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