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).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-small Cell Lung
• Intervention / Treatment: Drug: Comparator: erlotinib monotherapy; Drug: Comparator: erlotinib + dalotuzumab

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; erlotinib	Drug: Comparator: erlotinib monotherapy; Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.; Other Names: 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 Names: TARCEVA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validate imaging platform and molecular markers	FDG response at Weeks 1 and 3 following chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival, overall survival	3 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 4, 2008
• First Submitted That Met QC Criteria: August 6, 2008
• First Posted (Estimate): August 7, 2008

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: April 1, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: 0646-008; 2008_518; CTRI/2009/091/000139 (Registry Identifier: CTRI)