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Tyrosine Kinase Inhibitor

Osimertinib for Early Stage Non-Small Cell Lung Cancer (ADAURA2 Trial)

Phase 3
Recruiting
Led By Jonathan Goldman, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complete surgical resection (R0) of the primary NSCLC by lobectomy, segmentectomy or sleeve resection
NSCLC, of non-squamous histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomisation up to approximately 10 years
Awards & highlights

ADAURA2 Trial Summary

This trial will study whether osimertinib can prevent recurrence of EGFRm non-small cell lung cancer in people who have had surgery to remove the tumor.

Who is the study for?
This trial is for adults who've had a complete surgical removal of non-squamous NSCLC and are fully recovered from surgery. They should have stage IA2 or IA3 disease, good performance status, and specific EGFR mutations. Women must use effective contraception; men agree to barrier methods. Exclusions include severe diseases, certain heart risks, prior cancer treatments for NSCLC, or history of interstitial lung disease.Check my eligibility
What is being tested?
The study tests the effects of Osimertinib against a placebo in patients with early-stage non-small cell lung cancer after tumor removal surgery. It aims to see if Osimertinib can prevent cancer recurrence better than no treatment post-surgery.See study design
What are the potential side effects?
While not specified here, common side effects of Osimertinib may include diarrhea, rashes, dry skin, nail changes like brittleness or inflammation around nails (paronychia), mouth sores (stomatitis), decreased appetite and weight loss.

ADAURA2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer was completely removed by surgery.
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My lung cancer is non-small cell and not squamous type.
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I am fully active or able to carry out light work.
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I am 18 years old or older.
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I have provided a tumor sample for testing.
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My lung cancer is non-squamous.
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I am willing to use condoms during the trial.
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My tumor has an EGFR mutation detected by a specific test.
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My cancer is in the early stages (IA2 or IA3).
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I am fully active or able to carry out light work.
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My cancer is in the early stages (IA2 or IA3).
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I am not pregnant and use effective birth control or cannot become pregnant.
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I have fully recovered from surgery and it's been 4 to 12 weeks since my operation.
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My lung cancer was completely removed by surgery.

ADAURA2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomisation up to approximately 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomisation up to approximately 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-Free Survival (DFS) in high-risk stratum
Secondary outcome measures
Central Nervous System (CNS) Disease-Free Survival (DFS) in both the high-risk stratum and the overall population
Disease-Free Survival (DFS) in overall population
Impact of osimertinib versus placebo on physical functioning
+3 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
Fatigue
10%
Blood creatine phosphokinase increased
8%
Diarrhoea
8%
Decreased appetite
8%
Cough
7%
Thrombocytopenia
7%
Constipation
7%
Mucosal inflammation
7%
Paronychia
7%
Pain in extremity
7%
Rash
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

ADAURA2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OsimertinibExperimental Treatment1 Intervention
Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo for osimertinib, orally, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,243 Previous Clinical Trials
288,527,392 Total Patients Enrolled
Jonathan Goldman, MDPrincipal InvestigatorUCLA Department of Medicine
2 Previous Clinical Trials
293 Total Patients Enrolled
Yasuhiro Tsutani, MD, PhDPrincipal InvestigatorKindai University Facility of Medicine

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05120349 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Osimertinib, Placebo
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT05120349 — Phase 3
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05120349 — Phase 3

Frequently Asked Questions

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

Has Osimertinib been deemed safe by the FDA for public consumption?

"Osimertinib is classified as a 3 on Power's safety scale. This means that while the medication has only been proven effective in Phase 3 trials, there is strong evidence supporting its efficacy and safety from multiple rounds of data."

Answered by AI

Has research like this been conducted before?

"Osimertinib has undergone 105 clinical trials in 51 countries and 1061 cities since the first one was conducted in 2013. The original study, sponsored by AstraZeneca, had 603 participants and completed Phase 1 & 2 of drug approval. As of now, 18318 similar trials have been completed."

Answered by AI

Is this research being conducted at a lot of hospitals in America?

"There are a total of 18 sites running this study presently, making it convenient for many people as there is bound to be a location close to them. The sites are located in Vancouver, Morristown and Grand Junction among other places."

Answered by AI

Are new participants being accepted into this research project?

"That is correct. The online information hosted on clinicaltrials.gov supports that this trial, which was established on February 21st 2020, is still recruiting patients. In total, 380 individuals are needed for the study across 18 different enrolment sites."

Answered by AI

How many people total are participating in this experiment?

"Yes, the trial is still recruiting participants. According to clinicaltrials.gov, the study was first posted on February 21st, 2022 and was last edited November 2nd, 2022. They are looking for a total of 380 individuals across 18 sites."

Answered by AI

Are there many peer-reviewed papers on Osimertinib?

"There are a total of 105 clinical trials for Osimertinib that are currently underway. Of these, 17 are in Phase 3. Many of the trials taking place are based out of Uniondale, New york but there are 4,724 locations running studies for this medication."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~234 spots leftby Aug 2027