Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Third Military Medical University

Status and phase

Unknown

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: malate Given orally

Study type

Interventional

Funder types

Other

Identifiers

NCT01210053

Yang-001

Details and patient eligibility

About

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether sunitinib is effective in treating non-small cell lung cancer.

PURPOSE: 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.

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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