AZD9291 for Lung Cancer

(FLAURA Trial)

Recruiting at 149 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

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.

Inclusion Criteria

Provision of informed consent prior to any study specific procedures, sampling, and analysis

I can provide a sample of my tumor for EGFR mutation testing.

I am 18 years old or older.

Exclusion Criteria

Your heart's electrical activity (QT interval) is too long when measured on an ECG.

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

I am not taking any strong CYP3A4 inducers.

Treatment Details

Interventions

• AZD9291 (Tyrosine Kinase Inhibitor)
• Erlotinib (Tyrosine Kinase Inhibitor)
• Gefitinib (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: AZD9291+ placebo Experimental Treatment 3 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 AZD9291 Active Control 3 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).

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland