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

A Phase II Trial of Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer After Failure of Platinum Doublet (Except Pemetrexed) Therapy

The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. A multicenter randomized controled trial (coded as CA031) showed that nab-paclitaxel in combination with carboplatin had higher response rate than traditional paclitaxel plus carboplatin, especially in squamous lung cancer. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer after failure of platinum-based doublet therapy.

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.