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Osimertinib + Chemotherapy for Lung Cancer (NeoADAURA Trial)
Phase 3
Recruiting
Led By Jamie Chaft, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016])
Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to an average of 12 weeks after the first dose
Awards & highlights
NeoADAURA Trial Summary
This trial is testing osimertinib as a possible treatment for resectable EGFRm NSCLC. It will compare it to standard of care chemotherapy alone, and will also test it in combination with chemotherapy.
Who is the study for?
This trial is for adults with a specific type of lung cancer (non-squamous NSCLC) that can be surgically removed. Patients must have certain EGFR mutations, good performance status, and no history of severe lung conditions or other cancers within the last 2 years. Prior cancer treatments for NSCLC are not allowed.Check my eligibility
What is being tested?
The study tests Osimertinib alone or combined with chemotherapy against standard-of-care chemotherapy in patients who can undergo surgery to remove their lung cancer. It's a Phase III trial where participants are randomly assigned to one of three groups.See study design
What are the potential side effects?
Osimertinib may cause diarrhea, rash, dry skin, nail changes, mouth sores; while chemotherapy drugs like Cisplatin and Carboplatin can lead to nausea, vomiting, hair loss and increased risk of infection.
NeoADAURA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My non-squamous NSCLC is at stage II - IIIB N2 and can be completely removed with surgery.
Select...
My lung cancer can be fully removed by surgery, as confirmed by a specialized team.
Select...
My tumor has EGFR mutations sensitive to specific treatments.
NeoADAURA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization to an average of 12 weeks after the first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to an average of 12 weeks after the first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Pathological Response (MPR)
Secondary outcome measures
Concordance of EGFRm status between tumour tissue DNA and patient-matched plasma-derived ctDNA
Corcordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples
Difference between treatment arms in change from baseline in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items)
+7 moreOther outcome measures
Cure rate
MPR using plasma-derived circulating-free tumour DNA (ctDNA)
Number of adverse events as assessed by CTCAE 5.0 and other clinical variables for safety and tolerability profile of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy prior to surgery compared with chemotherapy alone
Side 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
NeoADAURA Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3: Osimertinib monotherapyExperimental Treatment1 Intervention
Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)
Group II: Arm 2: Osimertinib with platinum-based chemotherapyExperimental Treatment4 Interventions
Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator) plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Group III: Arm 1: Placebo with platinum-based chemotherapyPlacebo Group4 Interventions
Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Cisplatin
2013
Completed Phase 3
~1940
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,653 Total Patients Enrolled
Jamie Chaft, MDPrincipal InvestigatorMemorial Sloan Kettering, USA
1 Previous Clinical Trials
24 Total Patients Enrolled
Walter Weder, MDPrincipal InvestigatorThoraxchirurgie Bethanien, Switzerland
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation or damage that needed steroids.My non-squamous NSCLC is at stage II - IIIB N2 and can be completely removed with surgery.My lung cancer is a mix of small cell and non-small cell types.I can care for myself and perform light activities without help.I am not using, nor can I stop using, certain medications or supplements that affect my liver enzymes.I have had cancer before, but it was treated, is not lung cancer, and has been inactive for over 2 years.I am 18 years old or older.My lung cancer can be fully removed by surgery, as confirmed by a specialized team.My cancer has spread to major organs or large lymph nodes.I have not had any systemic anti-cancer treatments for my lung cancer.My tumor has EGFR mutations sensitive to specific treatments.My lung cancer is at an early or advanced stage, but not the final stage.I am scheduled for radiotherapy before surgery as part of my treatment.I have been treated with EGFR-TKI therapy before.I am a candidate for a minor lung surgery.I am under 20, living in Japan, and have consent from myself and my legal guardian.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Placebo with platinum-based chemotherapy
- Group 2: Arm 2: Osimertinib with platinum-based chemotherapy
- Group 3: Arm 3: Osimertinib monotherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom does this research opportunity extend?
"Eligibility requirements for this lung cancer study include being between 18-100 years old and having a diagnosis of non-small cell lung carcinoma. So far, the research team has enrolled 328 patients."
Answered by AI
Does this research include elderly patients?
"This clinical trial is open to individuals aged 18 or older but younger than 100."
Answered by AI
How many people are being given the chance to participate in this test?
"Yes, the trial is still looking for patients. It was first posted on December 16th 2020 and was most recently edited on November 8th 2022. The trial is searching for 328 patients across 18 sites."
Answered by AI
Are people still being signed up for this experiment?
"Yes, this study is still looking for volunteers according to the latest update on clinicaltrials.gov. The posting went up on December 16th, 2020 and was last edited November 8th, 2022."
Answered by AI
Does this trial have a high number of participating locations in our state?
"This study is presently enrolling patients at 18 sites. The locations are located in Santa Rosa, Boston and Montreal along with other 15 locations. It is important to select the location nearest you to minimize travel requirements if you participate."
Answered by AI
Has Osimertinib received FDA approval in the United States?
"Osimertinib's safety is based on some efficacy data as well as multiple rounds of supporting data, so it was given a 3."
Answered by AI
What other cases of research exist that use Osimertinib?
"Osimertinib was first researched in 1997 at City of Hope Comprehensive Cancer Center. Since the publication of those findings, there have been over 20000 completed trials. Right now, 1305 clinical trials are ongoing; a few of these studies are based in Santa Rosa, Massachusetts."
Answered by AI
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