Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.
The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.
Inclusion Criteria:
Exclusion Criteria:
Lake Spivey, Georgia 30236, United States
Pribram I, 261 26, Czechia
Pribram V, 261 95, Czechia
Clermond-Ferrand Cedex 01, 63003, France
Saint Pierre La Réunion Cedex, 97448, France
Shatin, New Territories, Hong Kong
Navrangpura / Ahmedabad, Gujarat 380 009, India
Osakasayama-shi, Osaka, Japan
Sakai-shi, Osaka, Japan
Chuo-Ku, Tokyo, Japan
Nitra-Zobor, 949 88, Slovakia
Niao Sung Hsiang, Kaohsiung Hsien 833, Taiwan