← Back to Search

Tyrosine Kinase Inhibitor

AZD9291 for Lung Cancer (FLAURA 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
Pathologically confirmed adenocarcinoma of the lung
Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
Must not have
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 inducers of cytochrome P450 (CYP) 3A4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36
Awards & highlights

Summary

This trial is testing a new drug to see if it is better than the current standard of care for patients with lung cancer that has spread.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that can't be treated with surgery or radiation. Participants must have specific EGFR mutations, no prior treatment for metastatic NSCLC, and a good performance status. They should not have severe diseases, uncontrolled heart conditions, or a history of certain lung issues.
What is being tested?
The study tests the effectiveness and safety of AZD9291 compared to standard treatments Erlotinib or Gefitinib in patients with advanced NSCLC. It involves taking either AZD9291 with placebo or one of the standard drugs alone.
What are the potential side effects?
Potential side effects include diarrhea, rash, dry skin, nail changes, mouth sores; less commonly interstitial lung disease (lung inflammation), liver enzyme elevation may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is confirmed to be adenocarcinoma.
Select...
My lung cancer cannot be cured with surgery or radiation.
Select...
My tumor has a specific EGFR mutation sensitive to treatment.
Select...
I can perform daily activities with little to no help, haven't gotten worse in the past 2 weeks, and am expected to live at least 12 more weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.
Select...
I am not taking any strong CYP3A4 inducers.
Select...
I have received treatment for advanced lung cancer before.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I have been treated with an EGFR-TKI before.
Select...
I do not have severe illnesses, uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.
Select...
I cannot take pills due to severe nausea, vomiting, or major gut surgery.
Select...
I have had lung inflammation or damage that needed steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median Progression Free Survival (PFS) (Months)
Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
Secondary study objectives
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
Depth of Response
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AZD9291+ placeboExperimental Treatment3 Interventions
AZD9291 (80 mg or 40 mg orally, once daily) plus placebo Erlotinib (150mg or 100mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily), in accordance with the randomization schedule.
Group II: Standard of Care + placebo AZD9291Active Control3 Interventions
Erlotinib (150 mg or 100 mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily) plus placebo AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomisation schedule. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,135 Total Patients Enrolled
ParexelIndustry Sponsor
308 Previous Clinical Trials
100,477 Total Patients Enrolled

Media Library

AZD9291 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02296125 — Phase 3
Lung Cancer Research Study Groups: AZD9291+ placebo, Standard of Care + placebo AZD9291
Lung Cancer Clinical Trial 2023: AZD9291 Highlights & Side Effects. Trial Name: NCT02296125 — Phase 3
AZD9291 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02296125 — Phase 3
~63 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top