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This Phase II Trial is Studying Sunitinib to See How Well it Works When Given as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Which is Previously Treated With Combination Chemotherapy.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

This Phase II Trial is Studying Sunitinib to See How Well it Works When Given as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Which is Previously Treated With Combination Chemotherapy.


OBJECTIVES:

Primary

- To investigate the effect of sunitinib malate on the progression-free survival of
patients with stage IIIB or IV non-small cell lung cancer Secondary

- To evaluate the toxicity of sunitinib when administered in the maintenance setting.

- To evaluate the additional response rate to sunitinib malate when administered in the
maintenance setting.

- To evaluate the overall survival of patients treated with sunitinib. After completion
of study treatment, patients are followed every 2 months for 1 year, every 6 months for
1 year, and periodically for 3 years.


Inclusion Criteria:



- No evidence of symptomatic or untreated brain metastases, spinal cord compression, or
carcinomatous meningitis

- Histologically or cytologically confirmed primary non-small cell lung cancer
who have stable or responding disease after prior treatment with 3-6 courses of
platinum -based therapy

- Not a candidate for combined modality therapy

- No cavitary lesions

Exclusion Criteria:

- Evidence of symptomatic or untreated brain metastases, spinal cord compression, or
carcinomatous meningitis

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

yang zhenzhou, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Authority:

United States: Food and Drug Administration

Study ID:

Yang-001

NCT ID:

NCT01210053

Start Date:

September 2010

Completion Date:

March 2012

Related Keywords:

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

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