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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 4, 2008
Last updated: April 1, 2016
Last verified: April 2016
This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).

Condition Intervention Phase
Carcinoma, Non-small Cell Lung
Drug: Comparator: erlotinib + dalotuzumab
Drug: Comparator: erlotinib monotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Validate imaging platform and molecular markers [ Time Frame: FDG response at Weeks 1 and 3 following chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, overall survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00729742

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00729742     History of Changes
Other Study ID Numbers: 0646-008  2008_518  CTRI/2009/091/000139 
Study First Received: August 4, 2008
Last Updated: April 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 23, 2016