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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib

Group Type EXPERIMENTAL

Sunitinib, chemotherapy

Intervention Type DRUG

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

Interventions

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Sunitinib, 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No