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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01210053

Enrollment

Registered

2010-09-28

Start date

2010-09-30

Completion date

2012-03-31

Last updated

2010-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer

Brief summary

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.

Detailed 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.

Interventions

DRUGmalate Given orally

Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	2 years

Secondary

Measure	Time frame
• Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival	2 years

Countries

China

Contacts

Primary Contactyang zhenzhou, doctor

yangzhenzhou@sohu.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026