Last updated on May 2017

Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy


Brief description of study

This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with stage IV NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 µg every 3 weeks , Group B: placebo Q3W)

Detailed Study Description

Oversight Authorities continued: Colombia- pending regulatory approval

Clinical Study Identifier: NCT00858364

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Ulm, Germany
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Athens, Greece
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Chania, Greece
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Larissa, Greece
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Nea Kifissia, Athens, Greece
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Piraeus, Greece
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Thessaloniki, Greece
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Ahmedabad, India
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Bangalore, India
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Kolkata, India
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Catania, Italy
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Faenza RA, Italy
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Grosseto, Italy
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Lecce, Italy
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Lugo RA, Italy
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Milano, Italy
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Napoli, Italy
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Ravenna, Italy
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Reggio Calabria, Italy
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San Giovanni Rotondo FG, Italy
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Nagoya-shi, Japan
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Fukui-Shi, Japan
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Chikushino-shi, Japan
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Kurume-shi, Japan
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Amagasaki-shi, Japan
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Kobe-shi, Japan
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Kobe, Japan
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Nishinomiya-shi, Japan
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Kanazawa, Japan
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Sagamihara-shi, Japan
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Okayama-shi, Japan
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Osaka-shi, Japan
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Bunkyo-ku, Japan
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Shinjuku-ku, Japan
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Yonago-shi, Japan
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Kyoto, Japan
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Cheongju-si, Chungcheongbuk-do, Korea, Republic of
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Daegu, Korea, Republic of
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Esch-Sur-Alzette, Luxembourg
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Luxembourg, Luxembourg
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Kota Bharu, Malaysia
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Georgetown, Malaysia
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Saltillo, Mexico
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Mexico City, Mexico
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Mexico, Mexico
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Guadalajara, Mexico
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Zapopan, Mexico
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Monterrey, Mexico
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Queretaro, Mexico
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San Luis Potosi, Mexico
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Merida, Mexico
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Chihuahua, Mexico
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Colima, Mexico
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Oaxaca, Mexico
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Puebla, Mexico
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Breda, Netherlands
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Eindhoven, Netherlands
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Rotterdam, Netherlands
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Davao City, Philippines
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Baguio City, Philippines
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Manila, Philippines
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Metro Manila, Philippines
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Quezon City, Philippines
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Bydgoszcz, Poland
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Krakow, Poland
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Olsztyn, Poland
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San Juan, Puerto Rico
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Timisoara, Romania
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Arkhangelsk, Russian Federation
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Barnaul, Russian Federation
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Belgorod, Russian Federation
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Ivanovo, Russian Federation
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Lipetsk, Russian Federation
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Moscow, Russian Federation
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Nizhniy Novgorod, Russian Federation
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Obninsk, Russian Federation
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Omsk, Russian Federation
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Orenburg, Russian Federation
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Pyatigorsk, Russian Federation
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Samara, Russian Federation
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Saratov, Russian Federation
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Tula, Russian Federation
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Ufa, Russian Federation
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Ulyanovsk, Russian Federation
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Voronezh, Russian Federation
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Yaroslavl, Russian Federation
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Belgrade, Serbia
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Gornji Matejevac, Serbia
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Kragujevac, Serbia
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Sremska Kamenica, Serbia
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Golnik, Slovenia
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Pohorje, Slovenia
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Umhlanga, South Africa
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Johannesburg, South Africa
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Overport, South Africa
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Polokwane, South Africa
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Granada, Spain
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Las Palmas de Gran Canaria, Spain
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Barcelona, Spain
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Benidorm, Spain
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Valencia, Spain
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Pontevedra, Spain
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Aarau, Switzerland
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Chur, Switzerland
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Sursee, Switzerland
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Zurich, Switzerland
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Changhua, Taiwan
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Chernihiv, Ukraine
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Chernivtsi, Ukraine
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Dnipropetrovsk, Ukraine
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Kirovograd, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Sumy, Ukraine
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Uzhgorod, Ukraine
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Vinnytsia, Ukraine
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Bebington, United Kingdom
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Dorechester, United Kingdom
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