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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

Pivotal Trial

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

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My lung cancer is confirmed to be adenocarcinoma.

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My lung cancer cannot be cured with surgery or radiation.

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My tumor has a specific EGFR mutation sensitive to treatment.

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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:

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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.

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I am not taking any strong CYP3A4 inducers.

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I have received treatment for advanced lung cancer before.

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I have not had major surgery in the last 4 weeks.

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I have been treated with an EGFR-TKI before.

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I do not have severe illnesses, uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.

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I cannot take pills due to severe nausea, vomiting, or major gut surgery.

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I have had lung inflammation or damage that needed steroids.

Timeline

Screening ~ 3 weeks3 visits

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

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

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

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).

0 / 12Eligibility criteria met