Know Cancer

or
forgot password

A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2


Inclusion Criteria:



- Advanced Non Small cell Lung Cell Lung cancer

- Never received chemotherapy

- Up and about 50% of waking hours

Exclusion Criteria:

- Spread of lung cancer to the brain

- Low level of white blood cells

- Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of
predictive factors such as smoking history, adenocarcinoma histology and mutation status
was described.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Date of randomization to earliest date of objective disease progression

Safety Issue:

No

Principal Investigator

AstraZeneca Canada Oncology Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Canada: Health Canada

Study ID:

1839IL/0551

NCT ID:

NCT00264498

Start Date:

October 2004

Completion Date:

June 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small-Cell Lung Cancer
  • NSCLC
  • Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location