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International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin 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

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Trial Information

International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin 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
(thrombocytopenia) also contributing to the decision. Subjects were allowed to complete
standard of care treatment/survival follow-up. Data collection was completed on 25 June
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 Group 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:

A8501002

NCT ID:

NCT00254904

Start Date:

November 2005

Completion Date:

June 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • advanced carcinoma, non-small cell lung, Phase III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteColumbia, Missouri  65201