OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain
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 wit
| Condition(s) | Non-small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 substitutio |
| Who can participate | 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 advance |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | A Coruña, Spain; Alicante, Spain; Barcelona, Spain; C Rdoba, Spain; El Palmar, Spain; Girona, Spain (+20 more sites) |
| Start date | 2023-07-28 |
| NCT ID | NCT06068049 |
| Official listing | https://clinicaltrials.gov/study/NCT06068049 |