Know Cancer

or
forgot password

A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small-Cell Lung Carcinoma

Thank you

Trial Information

A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)


Inclusion Criteria:



- Patients with Non-small cell lung cancer for which the standard cancer treatments of
surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate
treatments for you.

Exclusion Criteria:

- Patients who have had standard cancer treatments of surgery, chemotherapy or other
systemic anti-cancer therapy within 4 weeks before start of study therapy.

- Three or more prior chemotherapy regimens.

- Significant cardiovascular events.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).

Outcome Time Frame:

Time to death in months

Safety Issue:

No

Principal Investigator

Peter Langmuir, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00044

NCT ID:

NCT00404924

Start Date:

November 2006

Completion Date:

September 2012

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Non-Small-Cell Lung Carcinoma
  • Adenocarcinoma
  • Squamous Cell Carcinoma
  • Large Cell Carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location