Observational study on osimertinib for lung cancer in Spain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather real-world evidence on the use of osimertinib in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) in Spain. It will include patients who have been treated with osimertinib, focusing on those with locally advanced or metastatic NSCLC, as well as those who have undergone complete tumor resection. The study will analyze patient outcomes and treatment effectiveness based on various cohorts defined by their treatment history and cancer stage. By collecting data from multiple research sites, the study seeks to provide insights into the real-world application of osimertinib in clinical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Boosting Osimertinib brain penetration with febuxostat in EGFR-mutated NSCLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.