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

Phase 1

Completed

• Conditions: Carcinoma, Non-small Cell Lung

• Registration Number: NCT00729742
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Study Start: 2009-02
• Primary Completion: 2010-06
• Study Completion: 2011-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Validate imaging platform and molecular markers	FDG response at Weeks 1 and 3 following chemotherapy

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, overall survival	3 months