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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Squamous Cell Carcinoma of Lung

Intervention / Treatment
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* Drug: nanoparticle albumin-bound paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed-consent form; Age no less than 18 years; Histologically confirmed locally advanced or metastatic squamous lung cancer; Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks; RECIST measurable lesions; Disease progression after failure of platinum-based doublet therapy; Adequate liver/renal/bone marrow function; Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end; Compliance, and can be followed up regularly. Exclusion Criteria: Pregnant or breast-feeding female, or not willing to take contraception measures during study; Radiotherapy within 30 days, systematic therapy within 21 days; Serious infection requiring antibiotics intervention during recruitment; Allergic to study drug; Require concurrent biological target therapy; More than grade 1 neuropathy; Uncontrolled brain metastasis or mental illness; Congestive heart failure, uncontrolled cardiac arrhythmia, etc; Other malignancy within 5 years; Can't be followed up or obey protocol; Ineligible by the judge of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nanoparticle albumin-bound paclitaxel<br>Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days. | Drug: nanoparticle albumin-bound paclitaxel<br>* Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.<br>* Other names: Abraxane, nab-paclitaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST). | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Measure of time from study treatment to disease progression or death. | up to 15 months | 
| Overall survival | Measure of time from study treatment to patient's death or lost to follow-up. | up to 2 years | 
| Quality of life | Determine the score change of quality of life between pre- and post-treatment. | up to 15 months | 
| Safety and tolerability | Percentage of patients who experience an adverse event during this study. | up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nanoparticle albumin-bound paclitaxel, Squamous Cell Carcinoma of Lung