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A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib


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

Thank you

Trial Information

A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib


Inclusion Criteria:



- Patients with locally advanced/metastatic non-small cell lung cancer

- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based
regimen

Exclusion Criteria:

- Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with
the exception of bevacizumab) or other angiogenesis inhibitors

- History of or known brain metastases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.

Outcome Time Frame:

Baseline to death or 28 days after last dose for the last participant

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:

A6181087

NCT ID:

NCT00457392

Start Date:

July 2007

Completion Date:

December 2012

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Non-small cell lung cancer
  • sunitinib
  • erlotinib
  • Phase 3
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site North Little Rock, Arkansas  72117
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 Columbia, Missouri  65201
Pfizer Investigational Site Las Vegas, Nevada  89128
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Salt Lake City, Utah  84112