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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).

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

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 more

Other outcome measures

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%

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

Dizziness

Back pain

Diarrhea

Musculoskeletal pain

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,367 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

Frequently Asked Questions

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

Does the FDA endorse chemotherapy as an effective cancer treatment?

"Chemotherapy, while not without its risks, has received a score of 3 because of the available data supporting its efficacy and safety."

Answered by AI

Are there certain ineligibilities which would preclude an individual from joining this research project?

"The requirements to participate in this study are that patients have a diagnosis of lung cancer and are between 18-130 years old. The goal is to enroll 419 patients in total."

Answered by AI

Does this study have a wide reach in terms of the number of participating clinics?

"There are 27 total active sites for this trial, which are situated in cities like Houston, Gainesville and Charleston. If you enroll in the study, choosing a location nearest to you will help reduce travel-related burden."

Answered by AI

What other treatments have been studied that use Chemotherapy?

"The first chemotherapy trials were conducted in 2002 at the Department of Radiation Oncology in the National Cancer Center. As of today, there have been a total of 267 active studies, with a large portion of these ongoing clinical trials taking place in Houston, Texas."

Answered by AI

Are there any participants currently needed for this experiment?

"As of now, this trial has paused recruitment. The study was first posted on 8/4/2014 and was most recently updated on 10/26/2022. However, if you are looking for other studies, there are presently 1940 studies actively enrolling participants with lung cancer and 267 trials for Chemotherapy that are still recruiting patients."

Answered by AI

For this particular research project, are volunteers of all ages being accepted?

"According to the enrollment requirements for this clinical trial, individuals must be aged 18 or older but not 130 years old or above."

Answered by AI

Could you share how many people are taking part in this experiment?

"Unfortunately, this clinical trial is not recruiting patients at the moment. Though, it is worth noting that the study was most recently updated on October 26th, 2022. For those searching for other studies, there are 1940 clinical trials actively enrolling participants with lung cancer and 267 clinical trials for Chemotherapy actively enrolling participants."

Answered by AI

Recent research and studies

Annals of OncologyJournal

Osimertinib Versus Platinum–pemetrexed for Patients with EGFR T790M Advanced NSCLC and Progression on a Prior Egfr-tyrosine Kinase Inhibitor: AURA3 Overall Survival Analysis

Papadimitrakopoulou, V.A., T.S. Mok, J.-Y. Han, M.-J. Ahn, A. Delmonte, S.S. Ramalingam, S.W. Kim, et al.. 2020. “Osimertinib Versus Platinum–pemetrexed for Patients with EGFR T790M Advanced NSCLC and Progression on a Prior Egfr-tyrosine Kinase Inhibitor: AURA3 Overall Survival Analysis”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2020.08.2100.

CancerJournal

Epidermal Growth Factor Receptor Mutation Analysis in Tissue and Plasma from the AURA3 Trial: Osimertinib Versus Platinum‐pemetrexed for T790M Mutation‐positive Advanced Non–small Cell Lung Cancer

Papadimitrakopoulou, Vassiliki A., Ji‐Youn Han, Myung‐Ju Ahn, Suresh S. Ramalingam, Angelo Delmonte, Te‐Chun Hsia, Janessa Laskin, et al.. 2019. “Epidermal Growth Factor Receptor Mutation Analysis in Tissue and Plasma from the AURA3 Trial: Osimertinib Versus Platinum‐pemetrexed for T790M Mutation‐positive Advanced Non–small Cell Lung Cancer”. Cancer. Wiley. doi:10.1002/cncr.32503.

Journal of Clinical OncologyJournal

CNS Efficacy of Osimertinib in Patients with T790m-positive Advanced Non–small-cell Lung Cancer: Data from a Randomized Phase III Trial (AURA3)

Wu, Yi-Long, Myung-Ju Ahn, Marina Chiara Garassino, Ji-Youn Han, Nobuyuki Katakami, Hye Ryun Kim, Rachel Hodge, et al.. 2018. “CNS Efficacy of Osimertinib in Patients with T790m-positive Advanced Non–small-cell Lung Cancer: Data from a Randomized Phase III Trial (AURA3)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2018.77.9363.

Journal of Clinical OncologyJournal