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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
No Placebo-Only Group
Pivotal 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.
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.
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.

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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and recist tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary pfs analysis). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) by Investigator Assessment
Secondary study objectives
Disease Control Rate (DCR) by Investigator Assessment
Duration of Response (DoR) by Investigator Assessment
Objective Response Rate (ORR) by Investigator Assessment
+1 more
Other study objectives
Time to First Subsequent Therapy (TFST)
Time to Second Subsequent Therapy (TSST)

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Vomiting
14%
Neutropenia
14%
Alanine aminotransferase increased
14%
White blood cell count decreased
14%
Thrombocytopenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Musculoskeletal pain
5%
Dizziness
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Awards & Highlights

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.

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
4,397 Previous Clinical Trials
289,121,237 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

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02151981 — Phase 3
Chemotherapy Research Study Groups: Platinum-based doublet chemotherapy, Osimertinib
Chemotherapy Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT02151981 — Phase 3
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02151981 — Phase 3
~37 spots leftby Nov 2025
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