500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages:18 and older
Inclusion Criteria: - Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma. - Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease. - No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization. - Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved. - ECOG performance status (PS) 0 or 1. Exclusion Criteria: - Patients with symptomatic central nervous system (CNS) metastases are not permitted. - Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted. - Patients with other active cancer types are not permitted.
Phase: Phase 3
Trial ID: NCT00596830
Not Accepting Healthy Volunteers