Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)
|ClinicalTrials.gov Identifier: NCT00729742|
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : April 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-small Cell Lung||Drug: Comparator: erlotinib + dalotuzumab Drug: Comparator: erlotinib monotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer|
|Study Start Date :||February 2009|
|Primary Completion Date :||June 2010|
|Study Completion Date :||May 2011|
Experimental: Part 1
Drug: Comparator: erlotinib monotherapy
Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.
Other Name: TARCEVA®
Experimental: Part 2
erlotinib + dalotuzumab
Drug: Comparator: erlotinib + dalotuzumab
Part II: All patients will receive 1 week of erlotinib 150 mg tablets per day.
Arm 1: Patients who experience a PET response will continue on erlotinib monotherapy until disease progression.
Arm 2: Patients who fail to receive a PET response will continue to take erlotinib in combination with dalotuzumab 10 mg/kg IV infusion once weekly. At the time of disease progression, patients on erlotinib monotherapy will be offered to crossover to dalotuzumab 10 mg/kg IV infusion once weekly in combination with erlotinib.
Other Name: TARCEVA®
- Validate imaging platform and molecular markers [ Time Frame: FDG response at Weeks 1 and 3 following chemotherapy ]
- Progression-free survival, overall survival [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729742
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|