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


Tracking Information

Start Date  ICMJEMay 2008
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 5, 2008)		Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00673049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 5, 2008)
  • To assess the safety and tolerability of multiple doses of CP 751,871 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To assess the efficacy of CP 751,871 in terms of ORR [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • To monitor for the occurrence of anti drug antibody in response to CP 751,871 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To collect PK data of CP 751,871 for population PK meta-analysis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To test for the presence of Circulating Tumor Cells (CTCs) expressing the IGF IR [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To assess the differences in health state utilities using the EQ-5D [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJETrial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer
Official Title  ICMJERandomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
Brief Summary

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous Cell
Intervention  ICMJE
  • Drug: CP 751,871 (Figitumumab) and Erlotinib
    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.
  • 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.
Study Arms / Comparison Groups
  • Arm A: Experimental
    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.
    Intervention: Drug: CP 751,871 (Figitumumab) and Erlotinib
  • Arm B: Active Comparator
    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

Recruitment Information

Estimated Enrollment  ICMJE600
Estimated Completion DateJune 2011
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service1-877-369-9753PfizerCancerTrials@emergingmed.com
Location Countries  ICMJEUnited States,   Argentina,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   France,   Greece,   Hungary,   Indonesia,   Ireland,   Italy,   Korea, Republic of,   Latvia,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovenia,   South Africa,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00673049
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study ID Numbers  ICMJEA4021018
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer