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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729742
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : April 4, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

August 4, 2008
August 7, 2008
April 4, 2016
February 2009
June 2010   (Final data collection date for primary outcome measure)
Validate imaging platform and molecular markers [ Time Frame: FDG response at Weeks 1 and 3 following chemotherapy ]
Same as current
Complete list of historical versions of study NCT00729742 on Archive Site
Progression-free survival, overall survival [ Time Frame: 3 months ]
Same as current
Not Provided
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Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)
A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer
This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-small Cell Lung
  • 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®
  • Drug: Comparator: erlotinib monotherapy
    Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.
    Other Name: TARCEVA®
  • Experimental: Part 1
    Intervention: Drug: Comparator: erlotinib monotherapy
  • Experimental: Part 2
    erlotinib + dalotuzumab
    Intervention: Drug: Comparator: erlotinib + dalotuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2011
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
  • Patient has measurable disease
  • Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
  • Patient is 18 years of age or older
  • Patient has a performance status of 0-2 on ECOG scale
  • Women of childbearing potential have a negative pregnancy test
  • Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
  • Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease

Exclusion Criteria:

  • Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
  • Patient has not recovered from adverse events from previous therapy within 4 weeks
  • Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
  • Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
  • Patient has untreated brain metastases
  • Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
  • Patient is taking part in another clinical study
  • Patient abuses drugs or alcohol
  • Patient is pregnant or breastfeeding
  • Subject is HIV positive
  • Patient has active hepatitis
  • Patient is using growth hormone or growth hormone inhibitors
  • Patient has poorly controlled diabetes mellitus
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
India,   Italy,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom
CTRI/2009/091/000139 ( Registry Identifier: CTRI )
Not Provided
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP