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

Phase 1

Conditions: on-small cell lung cancer
MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2007-005941-39-DK

Lead Sponsor: Merck & Co. Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 95

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase I: To determine the safety and tolerability of erlotinib in combination with MK-0646 in patients with recurrent NSCLC.<br>Phase II: To evaluate the effect of the combination of erlotinib and MK-0646 on PFS in patients with recurrent NSCLC. <br>;Secondary Objective: Radiological: To quantify response rate (RR) by response criteria in solid tumors (RECIST) criteria.<br><br>Clinical: To determine overall survival (OS).<br>;Primary end point(s): The difference in progression-free survival (PFS) between treatment groups.

Secondary Outcome Measures