Clinical trial · Interventional
A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT00087711CI-TRIAL-00040548completedPhase 3ClinicalTrials.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 is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: pemetrexed
- Drug: cisplatin
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: gemcitabine
- Drug: cisplatin
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- baseline to date of death from any cause
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV. * No prior chemotherapy for lung cancer. * Patients must have at least one uni-dimensionally measurable lesion. * Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment. Exclusion Criteria: * Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious cardiac condition. * Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study. * Inability or unwillingness to take folic acid or Vitamin B12 supplementation. * Presence of fluid retention that cannot be controlled by drainage.
References
Publications (2)
- DERIVEDWu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17. PMID 25082564
- DERIVEDGridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23. PMID 22266043