Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00729742
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comparator: erlotinib + dalotuzumab — DRUG
    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.
  • Comparator: erlotinib monotherapy — DRUG
    Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.

Study Details

This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).

Key Dates

First listed
Aug 7, 2008
Start date
Feb 28, 2009
Status verified
Apr 2016
Primary completion
Jun 30, 2010
Completion
May 31, 2011

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    erlotinib
  • Experimental: Part 2
    erlotinib + dalotuzumab

Primary Outcome Measure

Validate imaging platform and molecular markers [ Time Frame: FDG response at Weeks 1 and 3 following chemotherapy ]

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