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Tyrosine Kinase Inhibitor

AZD9291 for Non-Small Cell Lung Cancer (ADAURA Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology

Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured by sf-36 questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 years.

Awards & highlights

ADAURA Trial Summary

This trial is testing a new drug, AZD9291, to see if it is effective and safe in treating a certain type of lung cancer.

Who is the study for?

This trial is for adults over 18 with Stage IB-IIIA non-small cell lung cancer that's been surgically removed. They must have specific EGFR mutations, no major organ issues, and can't be on certain drugs or have had certain treatments. Women must not be pregnant and use birth control.Check my eligibility

What is being tested?

The trial tests the effectiveness of AZD9291 (a targeted cancer drug) against a placebo in patients who've had surgery for lung cancer. Some may also receive standard chemotherapy. The goal is to see if AZD9291 improves outcomes post-surgery.See study design

What are the potential side effects?

Possible side effects of AZD9291 include diarrhea, rash, dry skin, nail changes, mouth sores, reduced appetite, coughing up blood and potential heart rhythm problems (QTc prolongation). It might also cause liver enzyme elevation.

ADAURA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed to be non-small cell and mostly not squamous.

Select...

My cancer was classified as Stage IB, II, or IIIA after surgery.

Select...

My tumor has EGFR mutations sensitive to treatment.

Select...

I can perform most of my daily activities without help.

Select...

My lung cancer was completely removed by surgery with no cancer cells at the edges.

ADAURA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured by sf-36 questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured by sf-36 questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured by sf-36 questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 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

Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).

Secondary outcome measures

Disease Free Survival (DFS) Rate at 2, 3 and 5 Years

Overall Survival (OS)

Overall Survival Rate at 2, 3 and 5 Years

+4 more

ADAURA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD9291Experimental Treatment2 Interventions

AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.

Group II: Placebo AZD9291Placebo Group1 Intervention

Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,220 Total Patients Enrolled

Media Library

AZD9291 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02511106 — Phase 3

Lung Carcinoma Research Study Groups: Placebo AZD9291, AZD9291

Lung Carcinoma Clinical Trial 2023: AZD9291 Highlights & Side Effects. Trial Name: NCT02511106 — Phase 3

AZD9291 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02511106 — Phase 3

Frequently Asked Questions

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

Has the FDA greenlit Open-label AZD9291 80 mg/40 mg yet?

"Open-label AZD9291 80 mg/40 mg is estimated to be a 3 in terms of safety. This is because multiple rounds of data support the safety of the drug and there is some data to suggest that it is effective."

Answered by AI

Can new people still join this experiment?

"This study is no longer recruiting patients. The listing originally went up on October 21st, 2015 but the most recent edit was on September 26th, 2022. If you are looking for similar studies, there are 4280 active trials for non-small cell lung carcinoma and 106 active trials for Open-label AZD9291 80 mg/40 mg."

Answered by AI

Are there other examples of Open-label AZD9291 80 mg/40 mg clinical trials?

"The first open-label clinical trial for AZD9291 80 mg/40 mg was conducted in 2013 at a research site. 28 trials have been completed thus far, with 106 active trials underway. A large proportion of these active studies are based in Santa Monica, California."

Answered by AI

Which type of person is this clinical trial meant for?

"This clinical trial is looking for 682 participants with non-small cell lung carcinoma aged 18 and up. To be eligible, candidates must meet the following criteria:-Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have evidence of non-child-bearing potential.-Male or female, aged at least 18 years.-Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology.-MRI or CT scan of the"

Answered by AI

Is this clinical trial taking place at multiple locations throughout North America?

"There are 24 sites conducting this clinical trial, with location in Santa Monica, Grand Junction, Toronto and other cities. To limit travel, it is recommended that you choose the nearest site to you."

Answered by AI

Is this particular clinical trial testing the effects of the medication on elderly patients?

"This trial is accepting patients aged 18-130, which is a much wider age range than most clinical trials. Out of 4,472 total trials, only 113 are for patients under 18 and 4,359 are for people over 65."

Answered by AI

Recent research and studies

Clinical Lung CancerJournal

ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection

Wu, Yi-Long, Roy S. Herbst, Helen Mann, Yuri Rukazenkov, Marcelo Marotti, and Masahiro Tsuboi. 2018. “ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2018.04.004.

egfrJournal

Osimertinib in egfr-mutated Lung Cancer

“Osimertinib in egfr-mutated Lung Cancer”. 2021. “Osimertinib in egfr-mutated Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmc2033951.

egfrJournal

Osimertinib in Resected egfr-mutated Non–small-cell Lung Cancer

Wu, Yi-Long, Masahiro Tsuboi, Jie He, Thomas John, Christian Grohe, Margarita Majem, Jonathan W. Goldman, et al.. 2020. “Osimertinib in Resected egfr-mutated Non–small-cell Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2027071.

egfrJournal