Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

• Carcinoma, Large Cell
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Carcinoma, Adenosquamous Cell

• Drug: CP 751,871 (Figitumumab)
  
  CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
• Drug: Erlotinib
  
  Erlotinib (one tablet of 150 mg/day PO).
• Drug: Erlotinib
  
  Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

• Experimental: Arm A
  

  The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.

  CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

  Interventions:
  

  • Drug: CP 751,871 (Figitumumab)
  • Drug: Erlotinib
• Active Comparator: Arm B
  
  Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)
  Intervention: Drug: Erlotinib

Inclusion Criteria:

• Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

• Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
• Prior Erlotinib therapy.
• Prior anti IGF IR based investigational therapy.