Clinical trial · Interventional
A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer
An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival Seen With Pemetrexed/Cisplatin and the Role of Thymidylate Synthase Expression
NCT00887549CI-TRIAL-00007214completedPhase 2Results postedClinicalTrials.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)
Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.
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 |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- interventionNames
- Drug: pemetrexed
- Drug: cisplatin
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)
- description
- PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous type * Patients must at least be able to be physically mobile, take care of yourself and be able to perform light activities such as light housework or office work * Patients must not have had previous chemotherapy treatment for lung cancer * Patients must not have had radiotherapy in the last 30 days * Patients must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computed tomography (CT) scan * Patients' test results assessing the function of their blood forming tissue, kidneys, liver and lungs are satisfactory * Women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception Exclusion Criteria: * Patients cannot have received other investigational drugs within the last 30 days * Patients cannot have any serious, uncontrolled medical condition that might compromise their ability to take part in the study safely * Patients cannot have a current second primary malignant tumor * Patients cannot be having current treatment with any other anti-tumor therapy * Patients cannot have had a yellow fever vaccination within 30 days of enrolment * Patients who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication * Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents * Patients who are pregnant or breastfeeding
References
Publications (1)
- DERIVEDFennell DA, Myrand SP, Nguyen TS, Ferry D, Kerr KM, Maxwell P, Moore SD, Visseren-Grul C, Das M, Nicolson MC. Association between gene expression profiles and clinical outcome of pemetrexed-based treatment in patients with advanced non-squamous non-small cell lung cancer: exploratory results from a phase II study. PLoS One. 2014 Sep 24;9(9):e107455. doi: 10.1371/journal.pone.0107455. eCollection 2014. PMID 25250715