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Tyrosine Kinase Inhibitor

Osimertinib + Chemotherapy for Non-Small Cell Lung Cancer (FLAURA2 Trial)

Phase 3
Waitlist Available
Led By Kunihiko Kobayashi, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M
Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC). NSCLC of mixed histology is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the analysis of landmark overall survival will be conducted at 2 time points: when pfs maturity is observed at approximately 33 months, and when overall survival maturity is observed at approximately 70 months after the first patient is randomized.
Awards & highlights

FLAURA2 Trial Summary

This trial is testing whether adding chemotherapy to osimertinib will help people with non-small cell lung cancer that has a specific DNA mutation and has gotten worse despite osimertinib.

Who is the study for?
Adults with untreated advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that can't be removed by surgery or cured with radiotherapy. They must have a specific EGFR mutation, good performance status, and life expectancy over 12 weeks. Those from Japan must be at least 20 years old. Participants should agree to use contraception and not have had prior treatments for advanced NSCLC.Check my eligibility
What is being tested?
The trial is testing if osimertinib combined with chemotherapy (Pemetrexed/Carboplatin or Pemetrexed/Cisplatin) is more effective than osimertinib alone in treating locally advanced or metastatic NSCLC. Patients are randomly assigned to either treatment group, with visits expected every few months for assessments.See study design
What are the potential side effects?
Osimertinib may cause diarrhea, rash, dry skin, nail toxicity, and mouth sores. Chemotherapy can lead to fatigue, nausea/vomiting, hair loss, anemia and increased risk of infection due to low blood cell counts.

FLAURA2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has a specific EGFR mutation sensitive to certain treatments.
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My lung cancer is non-squamous NSCLC, possibly with mixed types.
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I am at least 18 years old, or 20 if I am from Japan.
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My advanced lung cancer cannot be treated with surgery or radiotherapy.
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My physical health has been stable with no major issues for the last 2 weeks.
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My lung cancer is advanced, cannot be cured by surgery or radiotherapy.

FLAURA2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall survival will be analyzed at 2 time points: when pfs maturity is observed at approximately 33 months after the first patient is randomized, and when os maturity is observed at approximately 70 months after the first patient is randomized
This trial's timeline: 3 weeks for screening, Varies for treatment, and overall survival will be analyzed at 2 time points: when pfs maturity is observed at approximately 33 months after the first patient is randomized, and when os maturity is observed at approximately 70 months after the first patient is randomized for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Change from baseline and time to deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30)
Change from baseline and time to deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
Concordance of epidermal growth factor receptor mutation status between the local epidermal growth factor receptor mutation test and the central cobas® epidermal growth factor receptor Mutation Test v2 results from tumor samples with evaluable results
+10 more

FLAURA2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Osimertinib 80 mg QD and platinum-based chemotherapyExperimental Treatment2 Interventions
Osimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks. Dose may be reduced to allow for the management of IP related toxicity.
Group II: Osimertinib 80mg QDActive Control1 Intervention
Osimertinib (AZD9291) 80mg QD. All patients randomized into this will only receive Osimertinib 80mg. Dose may be reduced to allow for the management of IP related toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed/Carboplatin
2012
Completed Phase 3
~210
Pemetrexed/Cisplatin
2012
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,470,834 Total Patients Enrolled
Kunihiko Kobayashi, MDPrincipal InvestigatorDepartment of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama, Japan
Pasi A. Jänne, MDPrincipal InvestigatorDana Farber Cancer Institute, 450 Brookline Avenue, LC4114, Boston, MA 02215, USA

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04035486 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Osimertinib 80 mg QD and platinum-based chemotherapy, Osimertinib 80mg QD
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT04035486 — Phase 3
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04035486 — Phase 3

Frequently Asked Questions

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

In how many separate places is this research being conducted?

"At the moment, there are a total of 28 clinical sites running this trial. The sites are conveniently located in Santa Rosa, Toronto, Pittsburgh, and 28 other cities. If you decide to enroll in this trial, try to pick a location that is close to reduce travel time and costs."

Answered by AI

Are Pemetrexed/Carboplatin treatments effective in cancer patients?

"Pemetrexed/Carboplatin is currently being trialed in 414 Phase 3 studies, 1306 studies in total. The majority of these clinical trials are taking place in Shanghai, but there are 70823 total locations running Pemetrexed/Carboplatin trials."

Answered by AI

How many test subjects are enrolled in this experiment?

"As of right now, this trial is not looking for any more participants. The listing for this study was first posted on July 2nd, 2019 and was updated most recently on September 29th, 2020. If you're interested in other studies, 2079 are currently recruiting patients with lung cancer and 1306 are recruiting patients for Pemetrexed/Carboplatin."

Answered by AI

Would this research be well-suited for individuals aged 50 or older?

"Based on the eligibility requirements set by the clinical trial, patients must be between 18 to 110 years old to participate."

Answered by AI

What has Pemetrexed/Carboplatin shown to be most effective in treating?

"Pemetrexed/Carboplatin can be used to give patients with lymphoma, non-hodgkin, malignant neoplasms, and advanced sarcoma a fighting chance."

Answered by AI

Are there any severe side effects associated with Pemetrexed/Carboplatin?

"Pemetrexed/Carboplatin has some efficacy data from Phase 3 trials and multiple rounds of safety data, so it is given a 3 for safety."

Answered by AI

Is this research program still recruiting new participants?

"Presently, this study is not recruiting patients. This study was first posted on 7/2/2019 and was last updated on 9/29/2022. For other studies, 2079 studies are actively looking for participants with lung cancer and 1306 studies for Pemetrexed/Carboplatin are actively recruiting patients."

Answered by AI

Would I be eligible to participate in this clinical trial?

"This study is looking for 587 patients with lung cancer between the ages of 18 and 110. The following criteria must also be met: patients must have untreated advanced Non-Small cell lung cancer (NSCLC) that cannot be cured with surgery or radiotherapy, be male or female, and be at least 18 years of age (patients from Japan must be at least 20 years of age). Additionally, the cancer must be pathologically confirmed as non-squamous NSCLC of mixed histology, newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IV"

Answered by AI
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~104 spots leftby Mar 2025