Clinical trial · Interventional
Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer
A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study
- 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)
A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Efficacy | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin, dexamethasone,vitamin B12, folic acid | Drug | — | UNRESOLVED |
| cisplatin, gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- interventionNames
- Drug: cisplatin, dexamethasone,vitamin B12, folic acid
- type
- ACTIVE_COMPARATOR
- label
- Group B
- interventionNames
- Drug: cisplatin, gemcitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 36months
Secondary outcomes (1)
- measure
- Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV 2. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors; 3. with an Eastern CooperativeOncology Group performance status of 0 or 1, 4. At least 18 years of age 5. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula. 6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment 7. patients had fully recovered from its acute effects. Exclusion Criteria: 1. peripheral neuropathy \> National Cancer Institute Common Toxicity Criteria grade 1 2. progressive brain metastases, 3. uncontrolled third-space fluid retention before study entry. 4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.
References
Publications (1)
- DERIVEDHuang Y, Liu Y, Zhou J, Xu N, Li B, Wu G, Fang J, Li K, Liu X, Liu W, Lu Y, Wang M, Liu W, Liang H, Zhang Y, Huang C, Wang S, Wang Y, Yu S, Chang J, Wang Z, Hu Z, Zhang L. [A randomized, controlled, multicenter clinical trial comparing pemetrexed/cisplatin and gemcitabine/cisplatin as first-line treatment for advanced nonsquamous non-small cell lung cancer]. Zhongguo Fei Ai Za Zhi. 2012 Oct;15(10):576-82. doi: 10.3779/j.issn.1009-3419.2012.10.03. Chinese. PMID 23075681