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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 SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteSalt Lake City, Utah  84112