NSCLCPhase 2NCT02631460
S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous NSCLC
A Phase 2 study testing S1 80-120 mg/d, pemetrexed 500 mg/m2 and carboplatin AUC=5 in people with NSCLC, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- S1 80-120 mg/d, pemetrexed 500 mg/m2 and carboplatin AUC=5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chemotherapy-naive patients with histologically or cytologically confirmed nonsquamous NSCLC, classified as stage IIIB not amenable to curative treatment or stage IV; EGFR wild type.
- At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors
- Eastern Cooperative Oncology Group performance status of 0 or 1
- 18 <age<75 years
- Patients had adequate bone marrow reserve and organ function.
- Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment and patients had fully recovered from its acute effects
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- Written informed consent was obtained directly from every patient
- Estimated life expectancy of at least 12 weeks.
- Patient compliance and geographic proximity that allow adequate follow up.
- Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate during and for 3 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Who cannot join
- Brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments);
- Serious infections or other serious complications.
- Uncontrolled third-space fluid retention before study entry. unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids
- Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- Pregnant or breast feeding.
- A distinct history of drug allergies
Trial locations and contacts
1 site in 1 country.
Li Zhang, MD contact
Yan Huang, MD contact
China1 site, 1 recruiting
- Recruiting
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yan Huang, MD, huangyan@sysucc.org.cn
Yan Huang, MD
About this study
Official title: A Randomized Phase II Study of S1 Plus Carboplatin Followed by Maintenance S1versus Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous Non-Small-Cell Lung Cancer
This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed or S1. The primary end point of this non-inferiority study was progression free survival（PFS）
- Conditions
- NSCLC
- Being tested
- S1 80-120 mg/d, pemetrexed 500 mg/m2, carboplatin AUC=5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1 80-120 mg/dDrug
d1, every 3 weeks
pemetrexed 500 mg/m2Drug
d1, every 3 weeks
carboplatin AUC=5Drug
d1, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| S1 and Carboplatin | Experimental | S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1 Receives: Drug: S1 80-120 mg/d; Drug: carboplatin AUC=5 |
| pemetrexed and Carboplatin | Active comparator | pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed Receives: Drug: pemetrexed 500 mg/m2; Drug: carboplatin AUC=5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS)
Measured: 3 years
Secondary outcomes (4)
Overall survival(OS)
Measured: 4 years
Disease control rate(DCR)
Measured: 3 years
Health-related quality of life
Measured: 3 years
Number of Participants with Adverse Events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Yan Huang, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631460
- Sponsor's protocol ID
- 5010-2015023
- Status last verified
- Dec 2015
- First submitted
- 12 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of S1 Plus Carboplatin Followed by Maintenance S1versus Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02631460
- Acronym / sponsor ID
- 5010-2015023
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Dec 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.
This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed or S1. The primary end point of this non-inferiority study was progression free survival（PFS）
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S1 and Carboplatin | Experimental | Drug: S1 80-120 mg/d, Drug: carboplatin AUC=5S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1 |
| pemetrexed and Carboplatin | Active comparator | Drug: pemetrexed 500 mg/m2, Drug: carboplatin AUC=5pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Chemotherapy-naive patients with histologically or cytologically confirmed nonsquamous NSCLC, classified as stage IIIB not amenable to curative treatment or stage IV; EGFR wild type.
- At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors
- Eastern Cooperative Oncology Group performance status of 0 or 1
- 18 <age<75 years
- Patients had adequate bone marrow reserve and organ function.
Key exclusion criteria (6 listed)
- Brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments);
- Serious infections or other serious complications.
- Uncontrolled third-space fluid retention before study entry. unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids
- Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- Pregnant or breast feeding.
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 |
|---|---|---|
| S1 80-120 mg/dd1, every 3 weeks | Drug | S1 and Carboplatin |
| pemetrexed 500 mg/m2d1, every 3 weeks | Drug | pemetrexed and Carboplatin |
| carboplatin AUC=5d1, every 3 weeks | Drug | S1 and Carboplatin, pemetrexed and Carboplatin |
Primary outcome
Progression free survival(PFS)
Time frame: 3 years
4 secondary outcomes
Overall survival(OS)
Time frame: 4 years
Disease control rate(DCR)
Time frame: 3 years
Health-related quality of life
Time frame: 3 years
Number of Participants with Adverse Events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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 Zhang, MD contact
Yan Huang, MD contact
Yan Huang, MD principal investigator
Sun Yat-Sen University Cancer Center
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 S1 80-120 mg/d, pemetrexed 500 mg/m2 and carboplatin AUC=5 in people with NSCLC, 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 10 inclusion and 6 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 16 Dec 2015. 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 Li Zhang, MD (zhangli@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: 3 years). 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 16 Dec 2015.