Clinical trial · Observational
Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive
A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a retrospective, multicenter and observational study of Osimertinib monotherapy treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M mutation-positive who have received the treatment within the Special Use Medication Program (SUMP) in Spain.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- To estimate the progression free survival of the Osimertinib Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous or Non-Squamous, non-small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), EGFRm/T790M, who received osimertinib treatment within the Spanish special use medication program of Osimertinib (SUMP). * Alive patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Exclusion Criteria: * Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form. * Patients who were accepted in the SUMP, but did not receive treatment.
References
Publications (1)
- DERIVEDProvencio M, Terrasa J, Garrido P, Campelo RG, Aparisi F, Diz P, Aguiar D, Garcia-Giron C, Hidalgo J, Aguado C, Gonzalez JG, Esteban E, Gomez-Aldavari L, Moran T, Juan O, Chara LE, Marti JL, Castro RL, Ortega AL, Moreno EM, Coves J, Sanchez Pena AM, Bosch-Barrera J, Gastaldo AS, Nunez NF, Del Barco E, Cobo M, Isla D, Majem M, Navarro F, Calvo V. Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group. BMC Cancer. 2021 Mar 6;21(1):230. doi: 10.1186/s12885-021-07922-5. PMID 33676426