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Osimertinib + Chemotherapy for Lung Cancer (NeoADAURA Trial)
Phase 3
Waitlist Available
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)
Must not have
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
Mixed small cell and NSCLC histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to an average of 12 weeks after the first dose
Awards & highlights
Pivotal Trial
Summary
This trial is testing osimertinib, a drug that targets cancer cells, either by itself or with chemotherapy. It focuses on patients with a specific type of lung cancer that has a mutation in the EGFR gene. The drug works by stopping the growth of cancer cells.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had lung inflammation or damage that needed steroids.
Select...
My lung cancer is a mix of small cell and non-small cell types.
Select...
My cancer has spread to major organs or large lymph nodes.
Select...
I have not had any systemic anti-cancer treatments for my lung cancer.
Select...
My lung cancer is at an early or advanced stage, but not the final stage.
Select...
I am scheduled for radiotherapy before surgery as part of my treatment.
Select...
I have been treated with EGFR-TKI therapy before.
Select...
I am a candidate for a minor lung surgery.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major Pathological Response (MPR)
Secondary study objectives
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)
Difference between treatment arms in change from baseline in EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items)
Disease free survival (DFS)
+4 moreOther study objectives
Cure rate
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Pemetrexed
2014
Completed Phase 3
~5550
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
Osimertinib
2017
Completed Phase 4
~1100
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include EGFR Tyrosine Kinase Inhibitors (TKIs) like Osimertinib, chemotherapy, and immunotherapy. Osimertinib works by selectively inhibiting the epidermal growth factor receptor (EGFR) with activating mutations, which are often present in NSCLC, thereby blocking the signaling pathways that promote cancer cell proliferation and survival.
Chemotherapy targets rapidly dividing cells, including cancer cells, by interfering with their DNA replication and cell division processes. Immunotherapy, such as anti-PD-1 or anti-PD-L1 antibodies, enhances the body's immune response against cancer cells by blocking the proteins that inhibit immune cell activity.
These treatments are crucial for NSCLC patients as they offer targeted and effective options to manage and potentially improve survival outcomes.
Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutation: First Line Treatment and Beyond.
Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutation: First Line Treatment and Beyond.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,378 Previous Clinical Trials
288,738,560 Total Patients Enrolled
Jamie Chaft, MDPrincipal InvestigatorMemorial Sloan Kettering, USA
1 Previous Clinical Trials
24 Total Patients Enrolled
Walter Weder, MDPrincipal InvestigatorThoraxchirurgie Bethanien, Switzerland
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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.
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