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Tyrosine Kinase Inhibitor
Osimertinib vs Chemotherapy for Lung Cancer (AURA3 Trial)
Phase 3
Waitlist Available
Led By Yilong Wu, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recist tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary pfs analysis).
Awards & highlights
AURA3 Trial Summary
This trial is studying osimertinib vs platinum-based doublet chemotherapy to see if they are better in treating patients with non-small cell lung cancer whose disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy and whose tumors contain a T790M mutation.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has worsened after treatment with EGFR TKI therapy and have a specific mutation (T790M) in their cancer. They should be relatively healthy, able to receive chemotherapy, and not have had certain recent treatments or multiple lines of NSCLC treatment.Check my eligibility
What is being tested?
The study compares Osimertinib, a targeted cancer drug, against standard platinum-based chemotherapy in patients whose lung cancer has progressed despite previous treatments. It's an open-label and randomized trial meaning both the researchers and participants know which treatment is being given.See study design
What are the potential side effects?
Osimertinib may cause diarrhea, rash, dry skin, nail changes or mouth sores. Chemotherapy can lead to nausea, vomiting, hair loss, fatigue and increased risk of infection. Side effects vary from person to person.
AURA3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recist tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary pfs analysis).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recist tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary pfs analysis).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) by Investigator Assessment
Secondary outcome measures
Disease Control Rate (DCR) by Investigator Assessment
Duration of Response (DoR) by Investigator Assessment
Objective Response Rate (ORR) by Investigator Assessment
+2 moreOther outcome measures
Time to First Subsequent Therapy (TFST)
Time to Second Subsequent Therapy (TSST)
Side effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
AURA3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OsimertinibExperimental Treatment2 Interventions
Osimertinib 80 mg, orally, once daily
Group II: Platinum-based doublet chemotherapyActive Control1 Intervention
pemetrexed 500mg/m2 + carboplatin AUC5 or pemetrexed 500mg/m2 + cisplatin 75mg/m2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,619,731 Total Patients Enrolled
Yilong Wu, MDPrincipal InvestigatorGuangdong General Hospital, Guangdong, 510030, China
14 Previous Clinical Trials
2,341 Total Patients Enrolled
Vassiliki A Papadimitrakopoulou, MDPrincipal InvestigatorThe University of Texas/M.D. Anderson Cancer Center, Houston, Tx, USA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You received chemotherapy before starting a certain type of treatment within the past 6 months.You have already tried more than one type of treatment for advanced non-small cell lung cancer.Your T790M mutation status needs to be confirmed by a central laboratory.You can move and take care of yourself without much difficulty.You have taken certain medications for a specific type of lung cancer within the last 8 days.You have at least one tumor that has not been treated with radiation before.You have non-small cell lung cancer that has spread to other parts of the body or is advanced.You have been diagnosed with non-small cell lung cancer through a tissue or cell sample.You have taken any experimental or anticancer drugs within 14 days before starting the study treatment.If you are on the chemotherapy treatment and your medical scans show that the cancer is getting worse.Your medical scans show that your disease got worse after your first treatment with a specific medication.You have already been treated with Osimertinib or another specific type of medication for your condition.
Research Study Groups:
This trial has the following groups:- Group 1: Platinum-based doublet chemotherapy
- Group 2: Osimertinib
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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