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| ID | Type | Description | Link |
|---|---|---|---|
| GO27811 | Other Identifier | Hoffmann-La Roche |
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This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEGF0444A | Drug | Intravenous repeating dose |
| |
| bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study) | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1 | Up to 24 months | |
| Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study) |
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Inclusion Criteria:
Exclusion Criteria:
Bevacizumab-Specific Exclusions:
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| Name | Affiliation | Role |
|---|---|---|
| Ina Rhee, M.D., Ph.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29438092 | Derived | von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhasz E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7. |
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| Drug |
Intravenous repeating dose |
|
| carboplatin | Drug | Intravenous repeating dose |
|
| paclitaxel | Drug | Intravenous repeating dose |
|
| placebo | Drug | Intravenous repeating dose |
|
| Up to 24 months |
| Overall survival (defined as the time from randomization until death from any cause) | Up to 24 months |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Santa Monica | California | 90404 | United States |
| Orlando | Florida | 32904 | United States |
| Port Saint Lucie | Florida | 34952 | United States |
| St. Petersburg | Florida | 33719 | United States |
| Tampa | Florida | 33603 | United States |
| Marietta | Georgia | 30060 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Wichita | Kansas | 67214-3728 | United States |
| Burnsville | Minnesota | 55337 | United States |
| Las Vegas | Nevada | 89148 | United States |
| Albany | New York | 12208 | United States |
| Columbus | Ohio | 43219 | United States |
| Portland | Oregon | 97239 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78731 | United States |
| Fort Worth | Texas | 76104 | United States |
| Vancouver | Washington | 98684 | United States |
| St Leonards | New South Wales | 2065 | Australia |
| Herston | Queensland | 4029 | Australia |
| Woodville South | South Australia | 5011 | Australia |
| Brno | 656 53 | Czechia |
| Ostrava - Poruba | 708 52 | Czechia |
| Le Mans | 72037 | France |
| Lyon | 69373 | France |
| Marseille | 13273 | France |
| Marseille | 13915 | France |
| Paris | 75571 | France |
| Saint-Herblain | 44805 | France |
| Toulouse | 31059 | France |
| Essen | 45122 | Germany |
| Gauting | 82131 | Germany |
| Großhansdorf | 22927 | Germany |
| Halle | 06120 | Germany |
| Budapest | 1121 | Hungary |
| Budapest | 1125 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Tatabánya | 2800 | Hungary |
| Bydgoszcz | 85-796 | Poland |
| Gdansk | 80-952 | Poland |
| ID | Term |
|---|---|
| C000626247 | parsatuzumab |
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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