Condition: Non-small Cell Lung Cancer · Sponsor: AstraZeneca
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Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers. Osimertinib is indicated as monotherapy for the first-line (1L) treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations in the EGFR, for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC, for the adjuvant treatment of adult patients with NSCLC stages IB-IIIA after complete resection of the tumor that has activating mutations of the EGFR, for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutation and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy for the 1L treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations. The FLAURA trial showed that treatment with osimertinib significantly prolongs PFS and improves overall survival (OS) compared to standard EGFR tyrosine kinase inhibitors. The results of the ADAURA study showed a reduction in the risk of recurrence or death by 83% in stages II to IIIA, and in 80% in stages IB-IIIA. Additionally, osimertinib demonstrated a highly statistically signific…
This description comes directly from the study's public registry record.
AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
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Inclusion Criteria: * Female or male patients, treated with osimertinib * Age ≥ 18 years at starts of osimertinib treatment (i.e., index date). * Patients histologically diagnosed with EGFRm NSCLC (before index date): * Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1). * Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2). * Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3). * Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4). * Provision of informed consent (for alive patients). Deceased patients who met the selection criteria when they started treatment with osimertinib could also be included in the study. Exclusion Criteria: * Osimertinib treatment administration in a clinical trial setting.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Research Site | A Coruña, Spain | Recruiting |
| Research Site | Alicante, Spain | Recruiting |
| Research Site | Barcelona, Spain | Recruiting |
| Research Site | C Rdoba, Spain | Recruiting |
| Research Site | El Palmar, Spain | Recruiting |
| Research Site | Girona, Spain | Recruiting |
| Research Site | Granada, Spain | Recruiting |
| Research Site | Jaén, Spain | Recruiting |
| Research Site | Las Palmas de Gran Canaria, Spain | Recruiting |
| Research Site | León, Spain | Recruiting |
| Research Site | Lleida, Spain | Recruiting |
| Research Site | Madrid, Spain | Recruiting |
+ 14 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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