A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy
This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.
Oversight Authorities continued: Colombia
Inclusion Criteria:
Exclusion Criteria:
Curitba, Paraná 81520-060, Brazil
Benesov U Prahy, 256 30, Czechia
Ostrava-Poruba, 708 52, Czechia
Köln-Merheim, 51109, Germany
Nea Kifissia, Athens, 14564, Greece
Poria Eylit, 15208, Israel
Faenza RA, 48018, Italy
Legnago VR, 37045, Italy
Lugo RA, 48022, Italy
Meldola FC, 47014, Italy
San Giovanni Rotondo FG, 71013, Italy
Kurume-shi, Fukuoka 830-0011, Japan
Amagasaki-shi, Hyōgo 660-8550, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Sagamihara-shi, Kanagawa 252-0375, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Yonago-shi, Tottori 683-8504, Japan
Dorechester, DT1 2JY, United Kingdom
Dorset, BH15 2JB, United Kingdom