A study comparing MK-0646 with Erlotinib for treatment of one type of lung cancer
- Conditions
- on Small Cell Lung CancerMedDRA version: 13.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-005941-39-SE
- Lead Sponsor
- Merck Sharp & Dohme (Sweden) AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 95
• Age greater than or equal to 18 years
• Histologically/cytologically documented, unresectable, locally advanced, recurrent or relapsed metastatic Stage IIIB/IV NSCLC
• Measurable disease
• ECOG performance status 0-2
• Adequate hematologic, renal, and hepatic function: ANC greater than or equal to 1,500/µl, platelet greater than or equal to 100,000/ µl, Creatinine <1.5mg/ml; T.bilirubin = ULN, AST/ALT = 1.5x ULN, etc.
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 69
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
• Prior EGFR – TKI inhibitor/anti-EGFR mAb therapy is not allowed
• Prior IGF1R - TKI inhibitor/anti-IGF1R mAb therapy is not allowed
• No more than 2 prior systemic therapies
• Patient who has not completed radiotherapy with complete resolution of toxicities at least 2 weeks prior to beginning this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method