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A Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (0646-007)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: March 26, 2008
Last updated: January 23, 2015
Last verified: January 2015
This study will look for the highest tolerated dose of dalotuzumab given in combination with erlotinib. The study will also investigate how well dalotuzumab works in conjunction with erlotinib at treating recurrent non-small cell lung cancer.

Condition Intervention Phase
Carcinoma, Non-small-cell Lung
Drug: Comparator: Dalotuzumab (MK0646)
Drug: Comparator: erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized Phase I/IIa Trial Evaluating MK0646 in Combination With Erlotinib for Patients With Recurrent Non-Small Cell Lung Cancer

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Safety and tolerability of the combination treatment; progression-free survival will be assessed using physical examinations, vital signs, ECOG performance status, complete blood count with differential and platelets, serum chemistry, adverse experience [ Time Frame: After each dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response rate and overall survival [ Time Frame: After each dose of study drug ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: March 2008
Study Completion Date: February 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 & 2
The Phase I part of the study will be a safety assessment of erlotinib in combination with dalotuzumab. Erlotinib will be administrated orally by mouth (PO) at 150 mg daily, and dalotuzumab IV at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the a dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV at 5 mg/kg weekly. The minimum Phase II dose of dalotuzumab will be 5 mg/kg weekly. If the 5 mg/kg dose is not tolerated, then Phase I will be terminated and Phase II will not be conducted.
Drug: Comparator: Dalotuzumab (MK0646)
Dalotuzumab IV infusion over 60 minutes at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV infusion over 60 minutes at 5 mg/kg weekly.
Drug: Comparator: erlotinib
Erlotinib will be administrated orally by mouth (PO) at 150 mg daily.

Detailed Description:
  • Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the IGF-1R
  • Dalotuzumab may act through

    • Inhibition of IGF-1-mediated cell signaling to cause reductions in tumor growth and spread
    • Antibody dependent cell-mediated cytotoxicity
    • In preclinical studies, dalotuzumab improved the activity of an anti-EGFR mAb and the activity of Erlotinib, a small molecule inhibitor of EGFR

Trial Duration of Treatment: Subjects will continue on the study for as long as their disease is not progressing and they do not have unmanageable side effects from the treatment.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer that has relapsed after chemotherapy/chemoratiotherapy.
  • Subject has had at least one chemotherapy regimen for recurrent or metastatic disease.
  • Subject is 18 years of age or older
  • Subject has a performance status of 0-2 on ECOG scale.
  • Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

  • Subject has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
  • Subject has not recovered from adverse events from previous therapy within 4 weeks
  • Subject has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
  • Subject has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
  • Subject has had more than 2 systemic chemotherapies for metastatic disease
  • Subject has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study
  • Subject is taking part in another clinical study
  • Subject has a primary central nervous system tumor
  • Subject abuses drugs or alcohol
  • Subject is pregnant or breastfeeding
  • Subject is HIV positive
  • Subject has a history of hepatitis B or C
  • Subject is using growth hormone or growth hormone inhibitors
  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.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00654420     History of Changes
Other Study ID Numbers: 0646-007  2007_605 
Study First Received: March 26, 2008
Last Updated: January 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on December 09, 2016