Clinical trial · Observational
An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer
An Observational Study to Evaluate AZD9291 Treatment in Patients With EGFR T790M Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Following Progression on at Least One Prior EGFR TKI Treatment
- 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)
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
- description
- PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression
Secondary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months
- description
- OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * At least 20 years of age * Patients who were in the AZD9291 Early Access Program * Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents * Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018 * Patients agree to provide the written informed consent or the informed consent is waived by IRB. Exclusion Criteria: • Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC
References
Publications (0)
Data not yet available