Squamous Cell Carcinoma of LungPhase 2NCT01969955
Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
A Phase 2 study testing nanoparticle albumin-bound paclitaxel in people with Squamous Cell Carcinoma of Lung, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Lung
- What is being tested?
- nanoparticle albumin-bound paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer institute and hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Junling Li, drlijunling@vip.163.com
Junling Li
About this study
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
The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.
Read the detailed description
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.
- Conditions
- Squamous Cell Carcinoma of Lung
- Being tested
- nanoparticle albumin-bound paclitaxel
- Keywords
- nanoparticle albumin-bound paclitaxel, Squamous Cell Carcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoparticle albumin-bound paclitaxelDrug
Also called Abraxane, nab-paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| nanoparticle albumin-bound paclitaxel | Experimental | Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days. Receives: Drug: nanoparticle albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Measured: up to one year
Secondary outcomes (4)
progression-free survival
Measure of time from study treatment to disease progression or death.
Measured: up to 15 months
Overall survival
Measure of time from study treatment to patient's death or lost to follow-up.
Measured: up to 2 years
Quality of life
Determine the score change of quality of life between pre- and post-treatment.
Measured: up to 15 months
Safety and tolerability
Percentage of patients who experience an adverse event during this study.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Junling, Chinese Academy of Medical Sciences
- Investigators
- Junling Li, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969955
- Sponsor's protocol ID
- CH-L-031
- Status last verified
- Apr 2014
- First submitted
- 22 Oct 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01969955
- Acronym / sponsor ID
- CH-L-031
- Conditions
- Squamous Cell Carcinoma of Lung
- Keywords
- nanoparticle albumin-bound paclitaxel, Squamous Cell Carcinoma of Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nanoparticle albumin-bound paclitaxel | Experimental | Drug: nanoparticle albumin-bound paclitaxelNanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nanoparticle albumin-bound paclitaxelAlso: Abraxane, nab-paclitaxelNanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days. | Drug | nanoparticle albumin-bound paclitaxel |
Primary outcome
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).
4 secondary outcomes
progression-free survival
Time frame: up to 15 months
Overall survival
Time frame: up to 2 years
Quality of life
Time frame: up to 15 months
Safety and tolerability
Time frame: up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junling Li principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nanoparticle albumin-bound paclitaxel in people with Squamous Cell Carcinoma of Lung, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junling Li (86-13801178891, drlijunling@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.