Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
Condition: Carcinoma, Squamous Cell; Carcinoma, Adenosquamous; Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Large Cell; Carcinoma, Adenosquamous
Intervention: CP-751,871 (Figitumumab); Carboplatin; Paclitaxel; Carboplatin; Paclitaxel
Intervention description: CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.; Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.; Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.; Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.; Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 681.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IGF-1R inhibitor; Non-small-cell lung carcinoma; CP-751; 871

Summary:

      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.
    

Eligibility criteria:

        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.