Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
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ClinicalTrials.gov Identifier: NCT01969955 |
Recruitment Status : Unknown
Verified April 2014 by LI Junling, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : October 25, 2013
Last Update Posted : April 25, 2014
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Condition or disease | Intervention/treatment | Phase |
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Squamous Cell Carcinoma of Lung | Drug: nanoparticle albumin-bound paclitaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2013 |
Estimated Primary Completion Date : | December 2014 |
Estimated Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
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Drug: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
Other Name: Abraxane, nab-paclitaxel |
- Objective response rate [ Time Frame: up to one year ]Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
- progression-free survival [ Time Frame: up to 15 months ]Measure of time from study treatment to disease progression or death.
- Overall survival [ Time Frame: up to 2 years ]Measure of time from study treatment to patient's death or lost to follow-up.
- Quality of life [ Time Frame: up to 15 months ]Determine the score change of quality of life between pre- and post-treatment.
- Safety and tolerability [ Time Frame: up to 18 months ]Percentage of patients who experience an adverse event during this study.
- secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues [ Time Frame: up to 15 months ]Correlationship between secreted protein acidic and rich in cysteine (SPARC) expression in tumor issue and the efficacy of nab-paclitaxel or prognosis of patients

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969955
Contact: Junling Li | 86-13801178891 | drlijunling@vip.163.com |
China, Beijing | |
Cancer institute and hospital, Chinese Academy of Medical Sciences | Recruiting |
Beijing, Beijing, China, 100021 | |
Contact: Junling Li drlijunling@vip.163.com | |
Principal Investigator: Junling Li |
Principal Investigator: | Junling Li | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
Responsible Party: | LI Junling, Professor and chief physician, Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01969955 |
Other Study ID Numbers: |
CH-L-031 |
First Posted: | October 25, 2013 Key Record Dates |
Last Update Posted: | April 25, 2014 |
Last Verified: | April 2014 |
nanoparticle albumin-bound paclitaxel Squamous Cell Carcinoma of Lung |
Carcinoma, Squamous Cell Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |