Non-small Cell Lung CancerNCT01860508
A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers
A study testing pemetrexed /carboplatin in people with Non-small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- pemetrexed /carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Feb 2014
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- .≥65 years or PS 2
- Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
- Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
- Presence of at least one index lesion measurable by CT scan or MRI
- leucocyte ≥ 3.5×109/L
- neutrophil ≥ 1.5×109/L
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- platelet ≥ 80×109/L
- Hemoglobin ≥ 9g/L
- ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
- BUN≤ 1.5×ULN
- Signed written informed consent
Who cannot join
- squamous carcinoma or small cell lung cancer
- Patients were allergic to pemetrexed
- Patients received chemotherapy before
- Uncontrolled acute infection
- .Uncontrolled pleural effusion
- Severe symptomatic heart disease
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- Severe infection or metabolic disfunction
- Patients with other malignant tumor
- Uncontrolled brain metastases
- Patients have accepted other clinical trials
- Female patients during their pregnant and lactation period, or patients without contraception
- Mental disorientation of disorder
- Glucocorticoids taboo
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Jia lei Wang, Master, 02164175590 ext. 8907, luwangjialei@hotmail.com
About this study
Official title: Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
PFS
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- pemetrexed /carboplatin
- Keywords
- Progression free Survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed /carboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed | Experimental | Not described Receives: Drug: pemetrexed /carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860508
- Sponsor's protocol ID
- 2013-PEM-WJL
- Status last verified
- Jul 2013
- First submitted
- 20 May 2013
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao X, Yu H, Zhao J, Wu X, Sun S, Luo Z, Wang H, Qiao J, Chang J, Wang J. Efficacy and safety of first-line pemetrexed plus carboplatin followed by single-agent pemetrexed maintenance in elderly Chinese patients with non-squamous non-small-cell lung cancer. Oncotarget. 2017 Sep 23;8(49):86384-86394. doi: 10.18632/oncotarget.21186. eCollection 2017 Oct 17.
PubMed 29156802
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
- ClinicalTrials.gov ID
- NCT01860508
- Acronym / sponsor ID
- 2013-PEM-WJL
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Progression free Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- First posted
- 22 May 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.
PFS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pemetrexed | Experimental | Drug: pemetrexed /carboplatin |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- .≥65 years or PS 2
- Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
- Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
- Presence of at least one index lesion measurable by CT scan or MRI
- BUN≤ 1.5×ULN
Key exclusion criteria (13 listed)
- squamous carcinoma or small cell lung cancer
- Patients were allergic to pemetrexed
- Patients received chemotherapy before
- Uncontrolled acute infection
- .Uncontrolled pleural effusion
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 |
|---|---|---|
| pemetrexed /carboplatin | Drug | pemetrexed |
Primary outcome
PFS
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- Derived from this study: PubMed 29156802Zhao X, Yu H, Zhao J, Wu X, Sun S, Luo Z, Wang H, Qiao J, Chang J, Wang J. Efficacy and safety of first-line pemetrexed plus carboplatin followed by single-agent pemetrexed maintenance in elderly Chinese patients with non-squamous non-small-cell lung cancer. Oncotarget. 2017 Sep 23;8(49):86384-86394. doi: 10.18632/oncotarget.21186. eCollection 2017 Oct 17.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pemetrexed /carboplatin in people with Non-small Cell Lung Cancer, run by Fudan University 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 11 inclusion and 13 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 8 Jul 2013. 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.
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 Jia lei Wang, Master (02164175590 ext. 8907, luwangjialei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from the first cycle of treatment (day one) to two month after the last cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01860508, which also lists 1 linked publication.
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 8 Jul 2013.