Non-small Cell Lung CancerPhase 2NCT01401192
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
A Phase 2 study testing Gemcitabine plus cisplatin and pemetrexed plus cisplatin in people with Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Gemcitabine plus cisplatin and pemetrexed plus cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Dec 2013
- 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
- Histologically confirmed nonsquamous NSCLC
- Stage IIIb, IV or recurrent NSCLC
- Age ≥ 18years
- ECOG performance status of 0 to 1
- Known TS immunohistochemical analysis data
- At least one measurable lesion by RECIST 1.1
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- No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
- Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
- At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
- Adequate renal function: estimated creatinine clearance ≥ 50mL/min
Who cannot join
- Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
- Patients with post-obstructive pneumonia or uncontrolled serious infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Myung-Ju Ahn, M.D., Ph.D.
Jong-Mu Sun, M.D., Ph.D.
About this study
Official title: A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer
This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Gemcitabine plus cisplatin, pemetrexed plus cisplatin
- Keywords
- thymidylate synthase
- 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.
Gemcitabine plus cisplatinDrug
Gemcitabine 1000mg/m2 D1, D8 \& cisplatin 70mg/m2 D1 every 3 weeks
pemetrexed plus cisplatinDrug
Pemetrexed 500mg/m2 \& cisplatin 70mg/m2 D1 every 3 weeks
pemetrexed plus cisplatinDrug
pemetrexed 500mg/m2 \& cisplatin 70mg/m2 every 3 weeks
Gemcitabine plus cisplatinDrug
Gemcitabine 1000mg/m2 D1, D8 \& cisplatin 70mg/m2 D1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| TS positive cohort & Gem/Cis Tx arm | Experimental | Among TS expression positive patients, some will be randomized to Gem/cis therapy Receives: Drug: Gemcitabine plus cisplatin |
| TS+ cohort & Pem/Cis arm | Active comparator | Among patients with TS+, randomised to Pem/cis chemotherapy Receives: Drug: pemetrexed plus cisplatin |
| TS negative cohort & Pem/Cis Tx arm | Active comparator | Among patients with TS-, some will be randomised to Pem/cis Tx arm Receives: Drug: pemetrexed plus cisplatin |
| TS negative cohort & Gem/Cis Tx arm | Experimental | Among patients with TS-, some will be randomised to Gem/Cis Tx arm Receives: Drug: Gemcitabine plus cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive value of TS expression
To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value
Measured: 12 months
Secondary outcomes (2)
response rate
Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
Measured: 12 months
response rate
Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2013 (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 Samsung Medical CenterThe 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
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Myung-Ju Ahn, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401192
- Sponsor's protocol ID
- 2011-06-006
- Status last verified
- Jul 2011
- First submitted
- 21 Jul 2011
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29.
PubMed 26124486
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01401192
- Acronym / sponsor ID
- 2011-06-006
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- thymidylate synthase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (estimated)
- First posted
- 25 Jul 2011 (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 trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TS positive cohort & Gem/Cis Tx arm | Experimental | Drug: Gemcitabine plus cisplatinAmong TS expression positive patients, some will be randomized to Gem/cis therapy |
| TS+ cohort & Pem/Cis arm | Active comparator | Drug: pemetrexed plus cisplatinAmong patients with TS+, randomised to Pem/cis chemotherapy |
| TS negative cohort & Pem/Cis Tx arm | Active comparator | Drug: pemetrexed plus cisplatinAmong patients with TS-, some will be randomised to Pem/cis Tx arm |
| TS negative cohort & Gem/Cis Tx arm | Experimental | Drug: Gemcitabine plus cisplatinAmong patients with TS-, some will be randomised to Gem/Cis Tx arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed nonsquamous NSCLC
- Stage IIIb, IV or recurrent NSCLC
- Age ≥ 18years
- ECOG performance status of 0 to 1
- Known TS immunohistochemical analysis data
Key exclusion criteria (2 listed)
- Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
- Patients with post-obstructive pneumonia or uncontrolled serious infection
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 |
|---|---|---|
| Gemcitabine plus cisplatinGemcitabine 1000mg/m2 D1, D8 \& cisplatin 70mg/m2 D1 every 3 weeks | Drug | TS positive cohort & Gem/Cis Tx arm |
| pemetrexed plus cisplatinPemetrexed 500mg/m2 \& cisplatin 70mg/m2 D1 every 3 weeks | Drug | TS+ cohort & Pem/Cis arm |
| pemetrexed plus cisplatinpemetrexed 500mg/m2 \& cisplatin 70mg/m2 every 3 weeks | Drug | TS negative cohort & Pem/Cis Tx arm |
| Gemcitabine plus cisplatinGemcitabine 1000mg/m2 D1, D8 \& cisplatin 70mg/m2 D1 every 3 weeks | Drug | TS negative cohort & Gem/Cis Tx arm |
Primary outcome
predictive value of TS expression
Time frame: 12 months
To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value
2 secondary outcomes
response rate
Time frame: 12 months
response rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
- Derived from this study: PubMed 26124486Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29.
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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.
Myung-Ju Ahn, M.D., Ph.D. principal investigator
Samsung Medical 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 Gemcitabine plus cisplatin and pemetrexed plus cisplatin in people with Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 2 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 Jul 2011. 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 South Korea. 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 Myung-Ju Ahn, Pf (822-3410-3459, silkahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive value of TS expression (time frame: 12 months). 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 NCT01401192, 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 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.