An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung Cancer

Active, not recruiting

• Conditions: on-small cell lung cancer; MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2007-005941-39-DE
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-15
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

•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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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