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| ID | Type | Description | Link |
|---|---|---|---|
| GO27761 | Other Identifier | Hoffmann-La Roche | |
| 2011-002224-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onartuzumab+Erlotinib | Experimental | Participants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first. |
|
| Placebo+Erlotinib | Placebo Comparator | Participants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) |
| Measure | Description | Time Frame |
|---|---|---|
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores | Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months) | |
| Onartuzumab Serum Concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivor Caro, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler | Arizona | 85224 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24687921 | Derived | Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib+/-onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31. |
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| Onartuzumab (MetMab) | Drug | Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle. |
|
|
| Placebo | Drug | Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle. |
|
| 1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months) |
| Percentage of Participants With Disease Progression or Death | Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) |
| Progression Free Survival (PFS) | Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) |
| Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1 | Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) |
| Hayward |
| California |
| 94545 |
| United States |
| Modesto | California | 95355 | United States |
| Oakland | California | 94611 | United States |
| Orange | California | 92868 | United States |
| Roseville | California | 95661 | United States |
| Sacramento | California | 95817 | United States |
| Sacramento | California | 95825 | United States |
| San Diego | California | 92108 | United States |
| San Francisco | California | 94115 | United States |
| San Jose | California | 95119 | United States |
| Santa Clara | California | 95051 | United States |
| South San Francisco | California | 94080 | United States |
| Vallejo | California | 94589 | United States |
| Walnut Creek | California | 94596 | United States |
| Boca Raton | Florida | 33486 | United States |
| Clearwater | Florida | 33761 | United States |
| Fort Myers | Florida | 33901 | United States |
| Jacksonville | Florida | 32207 | United States |
| Jacksonville | Florida | 32256 | United States |
| Chicago | Illinois | 60637 | United States |
| Urbana | Illinois | 61801 | United States |
| Bettendorf | Iowa | 52722 | United States |
| Sioux City | Iowa | 51101 | United States |
| Louisville | Kentucky | 40207 | United States |
| Annapolis | Maryland | 21401 | United States |
| Baltimore | Maryland | 21201 | United States |
| Baltimore | Maryland | 21231 | United States |
| Baltimore | Maryland | 21237 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02115 | United States |
| Springfield | Massachusetts | 01107 | United States |
| Ann Arbor | Michigan | 48106 | United States |
| Duluth | Minnesota | 55805 | United States |
| St Louis | Missouri | 63110 | United States |
| Omaha | Nebraska | 68114 | United States |
| Reno | Nevada | 89502 | United States |
| Farmington | New Mexico | 87401 | United States |
| Syracuse | New York | 13210 | United States |
| Chapel Hill | North Carolina | 27514 | United States |
| Canton | Ohio | 44718 | United States |
| Cleveland | Ohio | 44106 | United States |
| Columbus | Ohio | 43210 | United States |
| Columbus | Ohio | 43219 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Charleston | South Carolina | 29403 | United States |
| Columbia | South Carolina | 29210 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Knoxville | Tennessee | 37909 | United States |
| Nashville | Tennessee | 37203 | United States |
| Dallas | Texas | 75390 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77030 | United States |
| Bristol | Virginia | 24201 | United States |
| Roanoke | Virginia | 24014 | United States |
| La Plata | B1900BAJ | Argentina |
| Quilmes | 1878 | Argentina |
| Santa Fe | S3000FFU | Argentina |
| Camperdown | New South Wales | 2050 | Australia |
| Waratah | New South Wales | 2298 | Australia |
| Chermside | Queensland | 4032 | Australia |
| Adelaide | South Australia | 5041 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Brussels | 1200 | Belgium |
| Ghent | 9000 | Belgium |
| Gilly (Charleroi) | 6000 | Belgium |
| Liège | 4000 | Belgium |
| Namur | 5000 | Belgium |
| Salvador/BA | Estado de Bahia | 41820-021 | Brazil |
| Lajeado | Rio Grande do Sul | 95900-000 | Brazil |
| Novo Hamburgo | Rio Grande do Sul | 93510-250 | Brazil |
| Jaú | São Paulo | 17210-080 | Brazil |
| São Paulo | São Paulo | 08270-070 | Brazil |
| Sorocaba | São Paulo | 18030-005 | Brazil |
| Saint John | New Brunswick | E2L 4L2 | Canada |
| Sault Ste. Marie | Ontario | P6A 2C4 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Montreal | Quebec | J4B 5Z7 | Canada |
| Santiago | 0 | Chile |
| Santiago | Providencia | Chile |
| Temuco | 4810469 | Chile |
| Čakovec | 40000 | Croatia |
| Dubrovnik | 20000 | Croatia |
| Pula | 52100 | Croatia |
| Zagreb | 10000 | Croatia |
| Besançon | 25030 | France |
| Caen | 14076 | France |
| Grenoble | 38 043 | France |
| Limoges | 87042 | France |
| Marseille | 13915 | France |
| Montpellier | 34295 | France |
| Paris | 75970 | France |
| Poitiers | 86021 | France |
| Saint-Herblain | 44805 | France |
| Suresnes | 92151 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Bad Berka | 99437 | Germany |
| Berlin | 14165 | Germany |
| Großhansdorf | 22927 | Germany |
| Hamburg | 21075 | Germany |
| Heidelberg | 69126 | Germany |
| Karlsruhe | 76137 | Germany |
| Mainz | 55131 | Germany |
| München | 80336 | Germany |
| Oldenburg | 26121 | Germany |
| Regensburg | 93053 | Germany |
| Ulm | 89081 | Germany |
| Villingen-Schwenningen | 78052 | Germany |
| Pokfulam | Hong Kong |
| Shatin | Hong Kong |
| Edelény | 3780 | Hungary |
| Miskolc | 3529 | Hungary |
| Szombathely | 9700 | Hungary |
| Cork | Ireland |
| Dublin | 8 | Ireland |
| Beersheba | 8410101 | Israel |
| Haifa | 4959381 | Israel |
| Jerusalem | 91120-01 | Israel |
| Jerusalem | 9372212 | Israel |
| Kfar Saba | 4428164 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 5262100 | Israel |
| Rehovot | 76100 | Israel |
| Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Milan | Lombardy | 20141 | Italy |
| Monza | Lombardy | 20900 | Italy |
| Rozzano | Lombardy | 20089 | Italy |
| Orbassano | Piedmont | 10043 | Italy |
| Ancona | The Marches | 60121 | Italy |
| Lido di Camaiore | Tuscany | 55043 | Italy |
| Perugia | Umbria | 06123 | Italy |
| Aichi | 464-8681 | Japan |
| Chiba | 277-8577 | Japan |
| Ehime | 791-0280 | Japan |
| Fukuoka | 811-1395 | Japan |
| Fukuoka | 812-8582 | Japan |
| Hyōgo | 650-0047 | Japan |
| Hyōgo | 673-8553 | Japan |
| Kanagawa | 236-0051 | Japan |
| Kyoto | 606-8507 | Japan |
| Miyagi | 980-8574 | Japan |
| Miyagi | 981-1293 | Japan |
| Okayama | 700-8558 | Japan |
| Okayama | 710-8602 | Japan |
| Osaka | 534-0021 | Japan |
| Osaka | 537-8511 | Japan |
| Osaka | 589-8511 | Japan |
| Osaka | 591-8555 | Japan |
| Saitama | 362-0806 | Japan |
| Shizuoka | 411-8777 | Japan |
| Tokyo | 104-0045 | Japan |
| Tokyo | 113-8677 | Japan |
| Tokyo | 135-8550 | Japan |
| Tokyo | 160-0023 | Japan |
| Tokyo | 173-8605 | Japan |
| Yamaguchi | 755-0241 | Japan |
| Amsterdam | 1081 HV | Netherlands |
| Groningen | 9700 RB | Netherlands |
| Maastricht | 6229 HX | Netherlands |
| Lima | L27 | Peru |
| Lima | Lima 1 | Peru |
| Lima | Lima 27 | Peru |
| Gdansk | 80-952 | Poland |
| Krakow | 31-531 | Poland |
| Lodz | 93-509 | Poland |
| Olsztyn | 10-357 | Poland |
| Poznan | Poland |
| Ivanovo | 153040 | Russia |
| Krasnodar | 350040 | Russia |
| Omsk | 644013 | Russia |
| Saint Petersburg | 189646 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saint Petersburg | 197101 | Russia |
| Tomsk | 634050 | Russia |
| Belgrade | 11000 | Serbia |
| Belgrade | 11080 | Serbia |
| Kragujevac | 34000 | Serbia |
| Bloemfontein | 9301 | South Africa |
| Johannesburg | 2193 | South Africa |
| Sandton | 2196 | South Africa |
| Gyeonggi-do | 443-380 | South Korea |
| Seoul | 05505 | South Korea |
| Seoul | 06591 | South Korea |
| Seoul | 120-752 | South Korea |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08041 | Spain |
| Barcelona | Barcelona | 08916 | Spain |
| Sabadell | Barcelona | 08208 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28050 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Valencia | Valencia | 41014 | Spain |
| Changhua | 500 | Taiwan |
| Kaohsiung City | 813 | Taiwan |
| Taipei | 100 | Taiwan |
| Cherkassy | 18009 | Ukraine |
| Chernivtsi | 58013 | Ukraine |
| Dnipropetrovsk | 49102 | Ukraine |
| Sumy | 40005 | Ukraine |
| Zaporizhzhya | 69040 | Ukraine |
| Belfast | BT9 7AB | United Kingdom |
| Grimsby | DN33 2BA | United Kingdom |
| Leicester | LE1 5WW | United Kingdom |
| London | SE1 9RT | United Kingdom |
| London | SW10 9NH | United Kingdom |
| Manchester | M2O 4BX | United Kingdom |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| C584058 | onartuzumab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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