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A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Non-small Cell

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Trial Information

A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung

Inclusion Criteria:

- Advanced adenocarcinoma of lung, measurable disease

- Non-smoker, or former light (less than 10 pack years and stopped at least 15 years);

- patients with known EGFR activating mutation regardless of smoking status

- ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive
NSCLC; may have had prior therapy

Exclusion Criteria:

- Active brain metastases

- Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had
any number of prior lines of systemic therapy.

- known EGFR wild type NSCLC

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort A] PFS is defined as the interval from enrollment to date of objective progression or death due to any cause.

Outcome Time Frame:

10 months

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

March 2015

Related Keywords:

  • Carcinoma, Non-Small Cell
  • lung cancer adenocarcinoma HER2
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Lung Neoplasms



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Bismarck, North Dakota  58503