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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_518 | |||
| CTRI/2009/091/000139 | Registry Identifier | CTRI |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | erlotinib |
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| Part 2 | Experimental | erlotinib + dalotuzumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: erlotinib + dalotuzumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Validate imaging platform and molecular markers | FDG response at Weeks 1 and 3 following chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, overall survival | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| Comparator: erlotinib monotherapy | Drug | Part I: All patients will receive erlotinib 150 mg tablets per day until disease progression. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C569480 | dalotuzumab |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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