Clinical trial · Interventional
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
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
NCT01401192CI-TRIAL-00005273unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine plus cisplatin | Drug | — | UNRESOLVED |
| pemetrexed plus cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- TS positive cohort & Gem/Cis Tx arm
- description
- Among TS expression positive patients, some will be randomized to Gem/cis therapy
- interventionNames
- Drug: Gemcitabine plus cisplatin
- type
- ACTIVE_COMPARATOR
- label
- TS+ cohort & Pem/Cis arm
- description
- Among patients with TS+, randomised to Pem/cis chemotherapy
- interventionNames
- Drug: pemetrexed plus cisplatin
- type
- ACTIVE_COMPARATOR
- label
- TS negative cohort & Pem/Cis Tx arm
- description
- Among patients with TS-, some will be randomised to Pem/cis Tx arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSun 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. PMID 26124486