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International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer


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

Thank you

Trial Information

International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer


PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the
trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis)
also contributing to the decision. Subjects were allowed to complete standard of care
treatment/survival follow-up. Data collection was completed on 17 July 2008.


Inclusion Criteria:



- Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage
IV

- No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy,
immunotherapy, biologic response modifiers or other investigational drugs

- Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

- Small cell or carcinoid lung cancer

- Known Central Nervous System (CNS) metastasis

- Pre-existing auto-immune or antibody mediated diseases

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:

656 Events

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:

A8501001

NCT ID:

NCT00254891

Start Date:

November 2005

Completion Date:

July 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
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 SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteBurlington, Vermont  05401-3456
Pfizer Investigational SiteSalt Lake City, Utah  84112
Pfizer Investigational SiteAnchorage, Alaska  99508
Pfizer Investigational SiteBangor, Maine  04401