Carcinoma, Non-Small-Cell LungPhase 3NCT03700333
Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced NSNSCLC
A Phase 3 study testing S-1 therapy and Pemetrexed therapy in people with Carcinoma, Non-Small-Cell Lung, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The purpose of this study is to compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- S-1 therapy and Pemetrexed therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2018to 20 Oct 2019
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Histological or cytological documented
- NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.1.
- Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD.
- Candidates's expected survival time should be greater than or equal to 3 months with ECOG performance status 0-1, adequate haematological and Hepatic- renal function, and cardiac function.
- At least one measurable tumor lesion (maximum diameter has to be greater than 10mm scan by CT or MRI) or malignant lymph node (15mm in short axis), and must not be accepted radiotherapy.
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- No any other following malignancy or any serious complication caused by metastatic encephaloma.
- No any gastrointestinal diseases that could reduce the drug absorption.
- Female: Candidates who have any chance to be pregnant must accept pregnancy tests 72 hours before therapy, and take medical allowed contraceptives during therapy or in 3 mouths after therapy. Pregnancy tests results must be negative.Lactation female are not included.
- Male: Be sterilized or take contraceptives during therapy or in 3 mouths after therapy.
Who cannot join
- Any unstable systemic disease
- Patients with exposure to any recent anticancer therapy outside of this trial.
- Pregnant or breast-feeding women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
The purpose of this study is to compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC.
Read the detailed description
S-1 consists of Tegafur,Gimeracil and Oteracil Potassium. Tegafur is metabolize to Gimeracil，and slows down the metabolism of 5-FU in high DPD enzyme expression tumor cell, so that 5-FU could bring the antimetabolic fiction more efficiently. Plenty of studies support that S-1 shows a desirable effect on advanced non-squamous NSCLC, and S-1 is more convenient compare with Pemetrexed. The curative effect of Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC has been proved to be valid. The purpose of our study is to explore whether S-1 could replace Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- S-1 therapy, Pemetrexed therapy
- Keywords
- Carcinoma, Non-Small-Cell Lung, S-1, Pemetrexed, maintenance therapy
- 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.
S-1 therapyDrug
accept S-1(50mg, twice a day, morning and night, if<1.5m2; 75mg, twice a day, morning and night,if >1.5m2 )chemotherapy after finishing first-line therapy(>21 days).
Pemetrexed therapyDrug
accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(>21 days).
| Study group | Role | What they receive |
|---|---|---|
| S-1 Group | Experimental | Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1) Receives: Drug: S-1 therapy |
| Pemetrexed Group | Active comparator | Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed Receives: Drug: Pemetrexed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival
From date of randomization until the date of first documented progression.
Measured: 1 year
Secondary outcomes (3)
overall survival
every subjects needs to be recorded the data of death.From date of randomization until the date of death from any cause.
Measured: 3 mouths, 6 mouths, 9 mouths, 1 year
objective response rate
ORR(objective response rate) is equal to the sum of cases of CR (complete response) and PR (partial response) divided by the total number of evaluable cases.From date of randomization until the date of first documented progression.
Measured: 3 mouths, 6 mouths, 9 mouths, 1 year
duration of response
From the date of first documented CR (complete response) or PR (partial response) until the date of first documented progression or recurrence.
Measured: 6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start20 Oct 2018 (estimated)
- Primary completion20 Oct 2019 (estimated)
- Study completion20 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 The First Affiliated Hospital with Nanjing Medical 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongqian Shu, MD, Study director, The First Affiliated Hospital with Nanjing Medical UniversityRenhua Guo, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700333
- Sponsor's protocol ID
- NHP-18-01
- Status last verified
- May 2018
- First submitted
- 9 Sep 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shirasaka T. Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol. 2009 Jan;39(1):2-15. doi: 10.1093/jjco/hyn127. Epub 2008 Dec 3.
PubMed 19052037Kubota K, Sakai H, Yamamoto N, Kunitoh H, Nakagawa K, Takeda K, Ichinose Y, Saijo N, Ariyoshi Y, Fukuoka M. A multi-institution phase I/II trial of triweekly regimen with S-1 plus cisplatin in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2010 May;5(5):702-6. doi: 10.1097/JTO.0b013e3181ce3e22.
PubMed 20150827Li XN, Qiu D, Pan X, Hou XX. Mutation of the epidermal growth factor receptor gene and its impact on the efficacy of gefitinib in advanced non-small cell lung cance. Int J Clin Exp Med. 2015 Apr 15;8(4):5397-405. eCollection 2015.
PubMed 26131116
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03700333
- Acronym / sponsor ID
- NHP-18-01
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, S-1, Pemetrexed, maintenance therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (estimated)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 20 Oct 2019 (estimated)
- First posted
- 9 Oct 2018 (actual)
- 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 compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC.
Detailed description
S-1 consists of Tegafur,Gimeracil and Oteracil Potassium. Tegafur is metabolize to Gimeracil，and slows down the metabolism of 5-FU in high DPD enzyme expression tumor cell, so that 5-FU could bring the antimetabolic fiction more efficiently. Plenty of studies support that S-1 shows a desirable effect on advanced non-squamous NSCLC, and S-1 is more convenient compare with Pemetrexed. The curative effect of Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC has been proved to be valid. The purpose of our study is to explore whether S-1 could replace Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1 Group | Experimental | Drug: S-1 therapyStage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1) |
| Pemetrexed Group | Active comparator | Drug: Pemetrexed therapyStage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent
- Histological or cytological documented
- NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.1.
- Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD.
- Candidates's expected survival time should be greater than or equal to 3 months with ECOG performance status 0-1, adequate haematological and Hepatic- renal function, and cardiac function.
Key exclusion criteria (3 listed)
- Any unstable systemic disease
- Patients with exposure to any recent anticancer therapy outside of this trial.
- Pregnant or breast-feeding women
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 |
|---|---|---|
| S-1 therapyaccept S-1(50mg, twice a day, morning and night, if<1.5m2; 75mg, twice a day, morning and night,if >1.5m2 )chemotherapy after finishing first-line therapy(>21 days). | Drug | S-1 Group |
| Pemetrexed therapyaccept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(>21 days). | Drug | Pemetrexed Group |
Primary outcome
progress free survival
Time frame: 1 year
From date of randomization until the date of first documented progression.
3 secondary outcomes
overall survival
Time frame: 3 mouths, 6 mouths, 9 mouths, 1 year
objective response rate
Time frame: 3 mouths, 6 mouths, 9 mouths, 1 year
duration of response
Time frame: 6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Results publication: PubMed 19052037Shirasaka T. Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol. 2009 Jan;39(1):2-15. doi: 10.1093/jjco/hyn127. Epub 2008 Dec 3.
- Results publication: PubMed 20150827Kubota K, Sakai H, Yamamoto N, Kunitoh H, Nakagawa K, Takeda K, Ichinose Y, Saijo N, Ariyoshi Y, Fukuoka M. A multi-institution phase I/II trial of triweekly regimen with S-1 plus cisplatin in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2010 May;5(5):702-6. doi: 10.1097/JTO.0b013e3181ce3e22.
- Results publication: PubMed 26131116Li XN, Qiu D, Pan X, Hou XX. Mutation of the epidermal growth factor receptor gene and its impact on the efficacy of gefitinib in advanced non-small cell lung cance. Int J Clin Exp Med. 2015 Apr 15;8(4):5397-405. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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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.
Yongqian Shu, MD study director
The First Affiliated Hospital with Nanjing Medical University
Renhua Guo, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-1 therapy and Pemetrexed therapy in people with Carcinoma, Non-Small-Cell Lung, run by The First Affiliated Hospital with Nanjing Medical University.
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 10 inclusion and 3 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Renhua Guo, MD (025-68136360, rhguo@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival (time frame: 1 year). 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 NCT03700333, which also lists 3 linked publications.
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 9 Oct 2018.