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Observational study on osimertinib for lung cancer in Spain

An Ambispective, Non-interventional, Multiple Cohort Study to Assess the Management of Osimertinib Treatment in Patients With EGFRm Non-small Cell Lung Cancer Under Real-world Conditions in Spain

Observational AstraZeneca · NCT06068049

This study looks at how well osimertinib works for people in Spain with a specific type of lung cancer and different treatment backgrounds.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsosimertinib, chemotherapy
Locations25 sites (Alicante and 24 other locations)
Trial IDNCT06068049 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been treated with osimertinib for EGFR mutation-positive NSCLC.

Not a fit: Patients who received osimertinib as part of a clinical trial will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of osimertinib, potentially improving treatment strategies for patients with EGFRm NSCLC.

How similar studies have performed: Other studies have shown success with osimertinib in treating EGFRm NSCLC, indicating that this approach is supported by prior evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Alicante and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.