Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)
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|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|
|Actual Primary Completion Date :||June 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729742
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|