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Tyrosine Kinase Inhibitor
Osimertinib for Early Stage Non-Small Cell Lung Cancer (ADAURA2 Trial)
Phase 3
Recruiting
Led By Yasuhiro Tsutani, MD, PhD
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
Must not have
Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention
Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomisation up to approximately 10 years
Awards & highlights
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 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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My lung cancer was completely removed by surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have lasting side effects from previous treatments above mild level.
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I haven't had major surgery or a serious injury in the last 4 weeks.
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I have a history of lung scarring or fibrosis.
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I had lung surgery that didn’t remove all of the cancer or only had a small portion removed.
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My bone marrow or organs are not functioning well.
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My cancer is a mix of small cell and non-small cell types.
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I have previously received cancer treatment for NSCLC.
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I am not taking any strong CYP3A4 inducers.
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I do not have severe illnesses, uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomisation up to approximately 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomisation up to approximately 10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease-Free Survival (DFS) in high-risk stratum
Secondary study objectives
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 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
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
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
~1100
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,429 Total Patients Enrolled
Yasuhiro Tsutani, MD, PhDPrincipal InvestigatorKindai University Facility of Medicine
Jie He, MD, PhDPrincipal InvestigatorThe Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have lasting side effects from previous treatments above mild level.My lung cancer was completely removed by surgery.My lung cancer is non-small cell and not squamous type.I am fully active or able to carry out light work.Any irregularities in your heart's electrical activity when measured at rest.I have conditions that could affect my heart's rhythm.I have fully recovered from surgery and it has been between 4 to 12 weeks since my operation.I haven't had major surgery or a serious injury in the last 4 weeks.I am 18 years old or older.I have provided a tumor sample for testing.I have a history of lung scarring or fibrosis.I had lung surgery that didn’t remove all of the cancer or only had a small portion removed.I had cancer before, but it was treated over 5 years ago and is not likely to come back.My lung cancer is non-squamous.I am willing to use condoms during the trial.My bone marrow or organs are not functioning well.My tumor has an EGFR mutation detected by a specific test.My cancer is a mix of small cell and non-small cell types.I have previously received cancer treatment for NSCLC.You are expected to live for at least 6 more months.My cancer is in the early stages (IA2 or IA3).I am not taking any strong CYP3A4 inducers.I do not have severe illnesses, uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.I am fully active or able to carry out light work.My cancer is in the early stages (IA2 or IA3).I am not pregnant and use effective birth control or cannot become pregnant.Your heart's electrical activity (ECG) shows a prolonged QTc interval when you are at rest.I have fully recovered from surgery and it's been 4 to 12 weeks since my operation.I am 18 years old or older.My lung cancer was completely removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Osimertinib
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- 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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