Locally advanced or metastatic non-small cell lung cancer where disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy MedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: na
Product Name: AZD9291 80 mg film-coated tablet
Product Code: AZD9291
Pharmaceutical Form: Capsule
Sponsors
Oslo university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ADvancer lung cancer, egfr mut+, efter previous tretament with an egfr inhibitor Ps 0-3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: PS 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy evaluation of AZD9291;Secondary Objective: Safety evaluation and translational aspects;Primary end point(s): Objective response rate assessed by RECIST 1.1;Timepoint(s) of evaluation of this end point: At baseline and every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS, DoR, DCR and OS Safety endpoints (CTCAE v4);Timepoint(s) of evaluation of this end point: At baseline and every 8 weeks | — |
Countries
Denmark, Finland, Lithuania, Norway, Sweden
Contacts
Public ContactClinical Trial Unit
Oslo university hospital
Outcome results
None listed