Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
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ClinicalTrials.gov Identifier: NCT01401192 |
Recruitment Status : Unknown
Verified July 2011 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : July 25, 2011
Last Update Posted : July 25, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: Gemcitabine plus cisplatin Drug: pemetrexed plus cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 304 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2011 |
Estimated Primary Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: TS positive cohort & Gem/Cis Tx arm
Among TS expression positive patients, some will be randomized to Gem/cis therapy
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Drug: Gemcitabine plus cisplatin
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks |
Active Comparator: TS+ cohort & Pem/Cis arm
Among patients with TS+, randomised to Pem/cis chemotherapy
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Drug: pemetrexed plus cisplatin
Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks |
Active Comparator: TS negative cohort & Pem/Cis Tx arm
Among patients with TS-, some will be randomised to Pem/cis Tx arm
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Drug: pemetrexed plus cisplatin
pemetrexed 500mg/m2 & cisplatin 70mg/m2 every 3 weeks |
Experimental: TS negative cohort & Gem/Cis Tx arm
Among patients with TS-, some will be randomised to Gem/Cis Tx arm
|
Drug: Gemcitabine plus cisplatin
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks |
- 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
- response rate [ Time Frame: 12 months ]Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
- response rate [ Time Frame: 12 months ]Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
- Patients with post-obstructive pneumonia or uncontrolled serious infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401192
Contact: Myung-Ju Ahn, Pf | 822-3410-3459 | silkahn@skku.edu |
Korea, Republic of | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: Myung-Ju Ahn, M.D., Ph.D. | |
Sub-Investigator: Jong-Mu Sun, M.D., Ph.D. |
Principal Investigator: | Myung-Ju Ahn, M.D., Ph.D. | Samsung Medical Center |
Responsible Party: | Myung-Ju Ahn, M.D., Ph.D., Samsung medical center |
ClinicalTrials.gov Identifier: | NCT01401192 |
Other Study ID Numbers: |
2011-06-006 |
First Posted: | July 25, 2011 Key Record Dates |
Last Update Posted: | July 25, 2011 |
Last Verified: | July 2011 |
thymidylate synthase |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Cisplatin Pemetrexed |
Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |