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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

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

FLAURA 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.Check my eligibility

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.See study design

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.

FLAURA Trial 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.

FLAURA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median Progression Free Survival (PFS) (Months)

Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months

Secondary outcome measures

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

FLAURA 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,112 Total Patients Enrolled

ParexelIndustry Sponsor

303 Previous Clinical Trials

100,152 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient wants to participate in this research, how many different hospitals might they have to go to?

"Currently, this clinical trial is being conducted in Burlington, Hamilton and Anaheim. However, there are 17 other locations where the study is happening. If you enroll, it would be convenient for you to choose a location that is nearest to you to limit travel time and effort."

Answered by AI

Is the target age group for this clinical trial over 40 years old?

"This study is looking for individuals who have not yet reached their century mark and are of legal age."

Answered by AI

What are the most common conditions that AZD9291+ placebo is used to manage?

"AZD9291+ placebo is commonly used to treat pancreatic metastatic cancer, as well as other conditions like pancreatic carcinoma, treatment naive patients, and malignant neoplasms."

Answered by AI

Are there previous examples of clinical trials using AZD9291+ placebo?

"The first clinical trial for the combination of AZD9291 and placebo was conducted in 2002 at Mayo Clinic's Rochester location. There have been a total of 529 completed studies since then. As of now, there are still 75 active trials being run; many out of Burlington, Vermont."

Answered by AI

Has the FDA cleared AZD9291+ placebo for use?

"This clinical trial is classified as a Phase 3, meaning that there is some data supporting the efficacy of the medication and multiple rounds of data supporting its safety. Our team at Power rates the safety of AZD9291+ placebo as a 3 on a scale from 1 to 3."

Answered by AI

Are recruitment efforts underway to fill the remainder of openings in this trial?

"No, the clinicaltrials.gov website says that this study is not currently looking for patients to enroll. The trial was initially posted on December 3rd, 2014 and last updated on August 25th, 2022. There are 2026 other studies recruiting participants right now."

Answered by AI

Might I be a candidate for this experiment?

"This study is looking for 674 participants that have malignant neoplasms and are aged 18+. Most notably, candidates must meet the following criteria: They must have NSCLC that cannot be cured by surgery or radiotherapy, they can't have received treatment before for their locally advanced or metastatic NSCLC, they must be eligible to receive first-line treatment with gefitinib or erlotinib, they must have a World Health Organization Performance Status of 0-1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks. Male or female patients that are at least 18 years"

Answered by AI

Recent research and studies

Japanese Journal of Clinical OncologyJournal

Osimertinib Versus Standard-of-care EGFR-TKI as First-line Treatment for Egfrm Advanced NSCLC: FLAURA Japanese Subset

Ohe, Yuichiro, Fumio Imamura, Naoyuki Nogami, Isamu Okamoto, Takayasu Kurata, Terufumi Kato, Shunichi Sugawara, et al.. 2018. “Osimertinib Versus Standard-of-care EGFR-TKI as First-line Treatment for Egfrm Advanced NSCLC: FLAURA Japanese Subset”. Japanese Journal of Clinical Oncology. Oxford University Press (OUP). doi:10.1093/jjco/hyy179.

egfrJournal

Overall Survival with Osimertinib in Untreated, <i>egfr</i>-mutated Advanced NSCLC

Ramalingam, Suresh S., Johan Vansteenkiste, David Planchard, Byoung Chul Cho, Jhanelle E. Gray, Yuichiro Ohe, Caicun Zhou, et al.. 2020. “Overall Survival with Osimertinib in Untreated, egfr-mutated Advanced NSCLC”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1913662.

Clinical Cancer ResearchJournal

Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib Versus Comparator EGFR Tyrosine Kinase Inhibitor as First-line Treatment in Patients with Egfr-mutated Advanced Non–small Cell Lung Cancer

Gray, Jhanelle E., Isamu Okamoto, Virote Sriuranpong, Johan Vansteenkiste, Fumio Imamura, Jong Seok Lee, Yong-Kek Pang, et al.. 2019. “Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib Versus Comparator EGFR Tyrosine Kinase Inhibitor as First-line Treatment in Patients with Egfr-mutated Advanced Non–small Cell Lung Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-1126.

Clinical Cancer ResearchJournal