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Osimertinib + Chemotherapy for Non-Small Cell Lung Cancer (FLAURA2 Trial)
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.
FLAURA2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFLAURA2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FLAURA2 Trial Design
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Who is running the clinical trial?
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- I've had treatments for early-stage lung cancer but none for advanced NSCLC since it recurred.My tumor has a specific EGFR mutation sensitive to certain treatments.I have been treated with EGFR-TKI before.I don't have active spinal issues or unstable brain tumors, and if I had brain treatment, I've been stable for 2 weeks without steroids.I have severe nausea, vomiting, gut diseases, trouble swallowing, or had major gut surgery affecting drug absorption.I have a history of lung conditions that required steroid treatment.I haven't had major surgery in the last 4 weeks, except for minor procedures like a biopsy.I do not have severe illnesses or infections that would make it unsafe for me to join the trial.You have a heart condition that affects your heartbeat.I haven't had extensive radiation to my bone marrow recently.My blood tests show my bone marrow or organs are not working well.My lung cancer is non-squamous NSCLC, possibly with mixed types.I am at least 18 years old, or 20 if I am from Japan.My advanced lung cancer cannot be treated with surgery or radiotherapy.My physical health has been stable with no major issues for the last 2 weeks.My lung cancer is advanced, cannot be cured by surgery or radiotherapy.
- Group 1: Osimertinib 80 mg QD and platinum-based chemotherapy
- Group 2: Osimertinib 80mg QD
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
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."
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."
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."
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"
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