A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

  • STATUS
    Recruiting
  • End date
    Mar 23, 2026
  • participants needed
    586
  • sponsor
    AstraZeneca
Updated on 5 April 2021
tyrosine
growth factor
kinase inhibitor
pemetrexed
carboplatin
epidermal growth factor receptor
EGFR
cancer treatment
cancer chemotherapy
epidermal growth factor
stage iv non-small cell lung cancer
osimertinib
recurrent non-small cell lung cancer
lung carcinoma
egfr t790m
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer

Summary

The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).

Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer.

In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer.

The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Osimertinib, Pemetrexed/cisplatin, Pemetrexed/Carboplatin
Clinical Study IdentifierNCT04035486
SponsorAstraZeneca
Last Modified on5 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 110 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Do you have any of these conditions: nsclc or Non-Small Cell Lung Cancer?
Do you have any of these conditions: Non-Small Cell Lung Cancer or nsclc?
Do you have any of these conditions: Non-Small Cell Lung Cancer or nsclc?
Do you have any of these conditions: nsclc or Non-Small Cell Lung Cancer?
Do you have any of these conditions: nsclc or Non-Small Cell Lung Cancer?
Do you have any of these conditions: Non-Small Cell Lung Cancer or nsclc?
Do you have any of these conditions: nsclc or Non-Small Cell Lung Cancer?
Do you have any of these conditions: nsclc or Non-Small Cell Lung Cancer?
Do you have any of these conditions: Non-Small Cell Lung Cancer or nsclc?
Male or female, at least 18 years of age; patients from Japan at least 20 years of age
Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC)
Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy
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
Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy
WHO PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
Life expectancy >12 weeks at Day 1
Willing to use contraception as appropriate during the study and for a period of time after discontinuing study treatment

Exclusion Criteria

Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids
Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial
QT prolongation or any clinically important abnormalities in rhythm
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy, biologic therapy, immunotherapy, or any investigational drug. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease
Prior treatment with an Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI)
Major surgery within 4 weeks of the first dose of investigational product (IP). Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery are permitted
Radiotherapy treatment to more than 30% of the bone marrow or( with a wide field of radiation within 4 weeks of the first dose of investigational product (IP)
History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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