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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Phase 2

Conditions

Lung Cancer
Cancer

Treatments

Drug: Sunitinib, chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01850147
SU-2013-041

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Sunitinib
Experimental group
Treatment:
Drug: Sunitinib, chemotherapy

Trial contacts and locations

1

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Central trial contact

Junling Li

Data sourced from clinicaltrials.gov

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