Overview

Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer

Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
Inclusion Criteria:

1. Signed informed-consent form;

2. Age no less than 18 years;

3. Histologically confirmed locally advanced or metastatic squamous lung cancer;

4. Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12
weeks;

5. RECIST measurable lesions;

6. Disease progression after failure of platinum-based doublet therapy;

7. Adequate liver/renal/bone marrow function;

8. Human Chorionic Gonadotropin (HCG) test negative for female with contraception
measures until 3 months after study end;

9. Compliance, and can be followed up regularly.

Exclusion Criteria:

1. Pregnant or breast-feeding female, or not willing to take contraception measures
during study;

2. Radiotherapy within 30 days, systematic therapy within 21 days;

3. Serious infection requiring antibiotics intervention during recruitment;

4. Allergic to study drug;

5. Require concurrent biological target therapy;

6. More than grade 1 neuropathy;

7. Uncontrolled brain metastasis or mental illness;

8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc;

9. Other malignancy within 5 years;

10. Can't be followed up or obey protocol;

11. Ineligible by the judge of the investigator.