FindTrial
Sign In

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004625-14-NL
Enrollment
48
Registered
2007-09-12
Start date
2008-09-11
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced non small cell lung cancer

Interventions

Trade Name: Tarceva Pharmaceutical Form: INN or Proposed INN: ERLOTINIB Trade Name: Nevaxar Pharmaceutical Form: Film-coated tablet

Sponsors

VU University Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: History of cardiac disease Symptomatic brain or leptomeningeal metastases History of bleeding diasthesis

Design outcomes

Primary

MeasureTime frame
Main Objective: •Efficacy of combination of erlotinib and sorafenib as determined by the rate of no progression at 6 weeks. •Determination of the impact of concomitant administration of sorafenib on the pharmacokinetics (PK) of erlotinib. ;Secondary Objective: •Efficacy of erlotinib and sorafenib as determined by -the objective response rate and disease control rate -duration of response -time to disease progression or death -survival -safety of erlotinib and sorafenib ;Primary end point(s): Rate of non progression at 6 weeks—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026