PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF OSIMERTINIB WITH OR WITHOUT PLATINUM PLUS PEMETREXED CHEMOTHERAPY, AS FIRST-LINE TREATMENT IN PATIENTS WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) MUTATION - POSITIVE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (FLAURA2)

AstraZeneca AB,0 个研究点目标入组 0 人开始时间: 2020年8月25日最近更新: 2024年8月20日

适应症

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•1 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2 Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses. 3 For patients who agree to the optional genetic testing, provision of signed and dated genetic testing section of the written Main ICF prior to collection of a sample for genetic analysis for inclusion in the optional genetic research as allowed by local regulations. 4 Male or female, at least 18 years of age; patients from Japan at least 20 years of age. 5 Pathologically confirmed nonsquamous NSCLC 6 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC (per Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology), not amenable to curative surgery or radiotherapy. 7 The tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M, assessed by a CLIA-certified (US sites) or an accredited (outside of the US) local laboratory or by central prospective tissue testing.

•1 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. Patients with asymptomatic brain metastases can be eligible for inclusion if in the opinion of the Investigator immediate definitive treatment is not indicated. 2 Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD. 3 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 or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.

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