A phase II study of erlotinib and sorafenib in patients with locally advanced and/or metastatic (stage IIIB or IV) Non-Small cell lung cancer (NSCLC) who have not received prior chemotherapy - phase II erlotinib-sorafenib in advanced NSCLC
- Conditions
- Advanced non small cell lung cancer
- Registration Number
- EUCTR2007-004625-14-NL
- Lead Sponsor
- VU University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Histologically advanced NSCLC
Normal organ function
ECOG PS 0-2
Age >18 yrs
Measurable disease
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
History of cardiac disease
Symptomatic brain or leptomeningeal metastases
History of bleeding diasthesis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •Efficacy of combination of erlotinib and sorafenib as determined by the rate of no progression at 6 weeks.<br>•Determination of the impact of concomitant administration of sorafenib on the pharmacokinetics (PK) of erlotinib. <br>;Secondary Objective: •Efficacy of erlotinib and sorafenib as determined by<br>-the objective response rate and disease control rate<br>-duration of response <br>-time to disease progression or death<br>-survival <br>-safety of erlotinib and sorafenib<br>;Primary end point(s): Rate of non progression at 6 weeks
- Secondary Outcome Measures
Name Time Method