ew targeted therapy in relapsed EGFR-mutated lung cancer previously treated with EGFR-inhibitors
- Conditions
- ocally advanced or metastatic non-small cell lung cancer where disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000307-10-FI
- Lead Sponsor
- Oslo university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): PFS, DoR, DCR and OS<br>Safety endpoints (CTCAE v4);Timepoint(s) of evaluation of this end point: At baseline and every 8 weeks