Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen

Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01850147

Enrollment

Registered

2013-05-09

Start date

2013-03-31

Completion date

2014-12-31

Last updated

2013-05-09

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

Conditions

Cancer, Lung Cancer

Keywords

sunitinib, chemotherapy, non-small cell lung cancer, NSCLC

Brief summary

The purpose of this study is to determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.

Interventions

DRUGSunitinib, chemotherapy

sunitinib, 12.5mg/day, for 7 days before each cycle of chemotherapy; chemotherapy, single agent including docetaxel, albumin-bound paclitaxel, vinorelbine, gemcitabine, pemetrexed, or paclitaxel, as determined by the investigator

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

* Histologic or cytologic diagnosis of stage IIIB/IV NSCLC * ECOG PS: 0,1 * Unidimensional or bi-dimensional measurable disease * Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor * Evidence of disease progression * Life expectancy \>12 weeks * Neutrophils \> 1.5 109/l, Platelets \> 100 109/l, Hemoglobin \> 9g/dl, Total bilirubin \< 1.5 UNL, AST (SGOT) and ALT (SGPT) \< 2.5 UNL, Alkaline phosphatases \< 5 UNL, Creatinine \< 1 UNL

Exclusion criteria

* Pre-existing hemoptysis of a severity \> grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry * Uncontrolled hypertension * CHF, angina or arrhythmias * LVEF \< 1 UNL * Existing a second malignancy within 5 years * Infected with HIV

Design outcomes

Primary

Measure	Time frame	Description
progression-free survival	up to 2 years	The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.

Secondary

Measure	Time frame	Description
overall survival	up to 2 years	To evaluate the median over-all survival of this regimen
disease control rate	up to 6 months	To evaluate the disease-control rate of this regimen.
Safety	up to 2 years	To evaluate the safety of this regimen including the rate and grade of adverse effects.

Countries

China

Contacts

Primary ContactJunling Li

drlijunling@yahoo.cn86-13801178891

Outcome results

None listed

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