Carcinoma，Non-Small-Cell LungPhase 3NACANCT02607592
A Prospective Multi-center Phase III Randomized Controlled Trial
A Phase 3 study testing cisplatin and pemetrexed and nedaplatin+pemetrexed in people with Carcinoma，Non-Small-Cell Lung, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value（OTV）on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma，Non-Small-Cell Lung
- What is being tested?
- cisplatin and pemetrexed and nedaplatin+pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Dec 2022
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology
- The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy
- Including one available evaluation lesion at least according to RECIST criteria
- Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1 .Life expectancy of at least 12 weeks.Haemoglobin ≥90g/dl, Absolute neutrophil count (ANC)≥ 2x 109/L, platelets ≥100 x 109/L. Total bilirubin ≤upper limit of normal (ULN). ALT and AST ≤ 2.5 x ULN. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula).
- Patients who had never received any antineoplastic therapy
Who cannot join
- Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ
- Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol
- Previous radiotherapy（Palliative radiotherapy in order to pain management can be excluded）
- Patient who has used chemotherapy before(bisphosphonate can be excluded )
- Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease
- Patient who is allergic to drugs we need to use
- Patients who are in pregnancy or lactation
- AST or ALT 》2.5 * upper limit of normal (ULN)，and ALP》5*ULN
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University of cancer center
Guangzhou, Guangdong, 510000
li-kun chen, doctor, 13798019964
About this study
Official title: Nedaplatin or Cisplatin Combined With Pemetrexed in the First Line Treatment of Advanced Adenocarcinoma：A Prospective Multi-center Phase III Randomized Controlled Trial
The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value（OTV）on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.
- Conditions
- Carcinoma，Non-Small-Cell Lung
- Being tested
- cisplatin and pemetrexed, nedaplatin+pemetrexed
- Keywords
- Non-Small-Cell Lung cancer, overall toxicity value
- 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.
cisplatin and pemetrexedDrug
cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
nedaplatin+pemetrexedDrug
nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
| Study group | Role | What they receive |
|---|---|---|
| Nedaplatin and Pemetrexed | Experimental | nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） Receives: Drug: nedaplatin+pemetrexed |
| Cisplatin and Pemetrexed | Active comparator | cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） Receives: Drug: cisplatin and pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free-survival（PFS）
Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Measured: 12months
Secondary outcomes (4)
objective response rate （ORR）
ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).
Measured: 12months
overall survival（OS）
OS is defined as the time from the starting date of study drug to the date of death due to any cause
Measured: 24 months
overall toxicity value
toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0
Measured: 12 months
Progression-Free Survival (PFS) rate at 18 weeks
the proportion (%) of patients without disease progression at 18 weeks
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (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 Carcinoma，Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-kun Chen, Sun Yat-sen University
- Investigators
- li-kun Chen, Doctor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607592
- Sponsor's protocol ID
- 201507003
- Acronym
- NACA
- Status last verified
- Feb 2022
- First submitted
- 16 Nov 2015
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.
PubMed 14691125
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nedaplatin or Cisplatin Combined With Pemetrexed in the First Line Treatment of Advanced Adenocarcinoma：A Prospective Multi-center Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02607592
- Acronym / sponsor ID
- NACA / 201507003
- Conditions
- Carcinoma，Non-Small-Cell Lung
- Keywords
- Non-Small-Cell Lung cancer, overall toxicity value
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 293 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Nov 2015 (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 investigate the PFS, ORR, OS and overall toxicity value（OTV）on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nedaplatin and Pemetrexed | Experimental | Drug: nedaplatin+pemetrexednedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） |
| Cisplatin and Pemetrexed | Active comparator | Drug: cisplatin and pemetrexedcisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology
- The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy
- Including one available evaluation lesion at least according to RECIST criteria
- Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1 .Life expectancy of at least 12 weeks.Haemoglobin ≥90g/dl, Absolute neutrophil count (ANC)≥ 2x 109/L, platelets ≥100 x 109/L. Total bilirubin ≤upper limit of normal (ULN). ALT and AST ≤ 2.5 x ULN. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula).
- Patients who had never received any antineoplastic therapy
Key exclusion criteria (8 listed)
- Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ
- Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol
- Previous radiotherapy（Palliative radiotherapy in order to pain management can be excluded）
- Patient who has used chemotherapy before(bisphosphonate can be excluded )
- Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease
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 |
|---|---|---|
| cisplatin and pemetrexedcisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） | Drug | Cisplatin and Pemetrexed |
| nedaplatin+pemetrexednedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） | Drug | Nedaplatin and Pemetrexed |
Primary outcome
progression free-survival（PFS）
Time frame: 12months
Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
4 secondary outcomes
objective response rate （ORR）
Time frame: 12months
overall survival（OS）
Time frame: 24 months
overall toxicity value
Time frame: 12 months
Progression-Free Survival (PFS) rate at 18 weeks
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Results publication: PubMed 14691125Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.
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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.
li-kun Chen, Doctor principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin and pemetrexed and nedaplatin+pemetrexed in people with Carcinoma，Non-Small-Cell Lung, run by Sun Yat-sen 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 5 inclusion and 8 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 Feb 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 li-kun chen, Doctor (13798019964, chenlk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free-survival（PFS） (time frame: 12months). 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 NCT02607592, 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 25 Feb 2022.