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Randomized, 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


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Carcinoma, Adenosquamous Cell

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Trial Information

Randomized, 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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

50 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021018

NCT ID:

NCT00673049

Start Date:

May 2008

Completion Date:

April 2012

Related Keywords:

  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous Cell
  • IGR-1R
  • Non small cell lung cancer
  • CP-751
  • 871
  • Figitumumab
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Lung Neoplasms
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site North Little Rock, Arkansas  72117
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Cedar Rapids, Iowa  52403
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Billings, Montana  59101
Pfizer Investigational Site Lebanon, New Hampshire  03766
Pfizer Investigational Site Cheyenne, Wyoming  82001
Pfizer Investigational Site Morgantown, West Virginia  26506