Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer, Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Description:

The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

SU-2013-041

NCT ID:

NCT01850147

Start Date:

March 2013

Completion Date:

December 2014

Related Keywords:

  • Cancer
  • Lung Cancer
  • sunitinib
  • chemotherapy
  • non-small cell lung cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location