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

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

Official Title
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A Phase 1b, Multicenter Trial to Evaluate Molecular Determinants of Response to Erlotinib and MK0646 in Advanced Non-Small-Cell Lung Cancer

Conditions
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Carcinoma, Non-small Cell Lung

Intervention / Treatment
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* Drug: Comparator: erlotinib + dalotuzumab
* Drug: Comparator: erlotinib monotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>erlotinib | Drug: Comparator: erlotinib monotherapy<br>* Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression.<br>* Other names: TARCEVA®;|
| Experimental: Part 2<br>erlotinib + dalotuzumab | Drug: Comparator: erlotinib + dalotuzumab<br>* 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.<br>* Other names: TARCEVA®;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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