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Tyrosine Kinase Inhibitor
Osimertinib + Chemotherapy for Non-Small Cell Lung Cancer (FLAURA2 Trial)
Phase 3
Waitlist Available
Led By Pasi A. Jänne, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M
Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy
Must not have
Prior treatment with an Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI)
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 45 months (maximum follow up 44.6 months)
Awards & highlights
Summary
This trial is testing whether adding chemotherapy to osimertinib will help people with non-small cell lung cancer that has a specific DNA mutation and has gotten worse despite osimertinib.
Who is the study for?
Adults with untreated advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that can't be removed by surgery or cured with radiotherapy. They must have a specific EGFR mutation, good performance status, and life expectancy over 12 weeks. Those from Japan must be at least 20 years old. Participants should agree to use contraception and not have had prior treatments for advanced NSCLC.
What is being tested?
The trial is testing if osimertinib combined with chemotherapy (Pemetrexed/Carboplatin or Pemetrexed/Cisplatin) is more effective than osimertinib alone in treating locally advanced or metastatic NSCLC. Patients are randomly assigned to either treatment group, with visits expected every few months for assessments.
What are the potential side effects?
Osimertinib may cause diarrhea, rash, dry skin, nail toxicity, and mouth sores. Chemotherapy can lead to fatigue, nausea/vomiting, hair loss, anemia and increased risk of infection due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor has a specific EGFR mutation sensitive to certain treatments.
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My advanced lung cancer cannot be treated with surgery or radiotherapy.
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My lung cancer is advanced, cannot be cured by surgery or radiotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with EGFR-TKI before.
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I have severe nausea, vomiting, gut diseases, trouble swallowing, or had major gut surgery affecting drug absorption.
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I have a history of lung conditions that required steroid treatment.
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I haven't had extensive radiation to my bone marrow recently.
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My blood tests show my bone marrow or organs are not working well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 45 months (maximum follow up 44.6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 45 months (maximum follow up 44.6 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)
Progression-free Survival (PFS) (Randomized Component)
Sensitivity Analysis for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment (Randomized Component)
Secondary study objectives
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) (Randomized Component)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC13) (Randomized Component)
Concordance of Epidermal Growth Factor Receptor (EGFR) Mutation Status Between the Local EGFR Mutation Test and the Central Cobas® EGFR Mutation Test v2 Results: Exon 19 Deletion (Randomized Component)
+26 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Osimertinib 80 mg QD and platinum-based chemotherapyExperimental Treatment2 Interventions
Osimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
Dose may be reduced to allow for the management of IP related toxicity.
Group II: Osimertinib 80mg QDActive Control1 Intervention
Osimertinib (AZD9291) 80mg QD.
All patients randomized into this will only receive Osimertinib 80mg.
Dose may be reduced to allow for the management of IP related toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed/Carboplatin
2012
Completed Phase 3
~210
Pemetrexed/Cisplatin
2012
Completed Phase 3
~210
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,222 Total Patients Enrolled
Pasi A. Jänne, MDPrincipal InvestigatorDana Farber Cancer Institute, 450 Brookline Avenue, LC4114, Boston, MA 02215, USA
Kunihiko Kobayashi, MDPrincipal InvestigatorDepartment of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama, Japan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had treatments for early-stage lung cancer but none for advanced NSCLC since it recurred.My tumor has a specific EGFR mutation sensitive to certain treatments.I have been treated with EGFR-TKI before.I don't have active spinal issues or unstable brain tumors, and if I had brain treatment, I've been stable for 2 weeks without steroids.I have severe nausea, vomiting, gut diseases, trouble swallowing, or had major gut surgery affecting drug absorption.I have a history of lung conditions that required steroid treatment.I haven't had major surgery in the last 4 weeks, except for minor procedures like a biopsy.I do not have severe illnesses or infections that would make it unsafe for me to join the trial.You have a heart condition that affects your heartbeat.I haven't had extensive radiation to my bone marrow recently.My blood tests show my bone marrow or organs are not working well.My lung cancer is non-squamous NSCLC, possibly with mixed types.I am at least 18 years old, or 20 if I am from Japan.My advanced lung cancer cannot be treated with surgery or radiotherapy.My physical health has been stable with no major issues for the last 2 weeks.My lung cancer is advanced, cannot be cured by surgery or radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Osimertinib 80 mg QD and platinum-based chemotherapy
- Group 2: Osimertinib 80mg QD
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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