Clinical trial · Interventional
Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
NCT00391274CI-TRIAL-00004671completedPhase 3Results 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)
The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.
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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- interventionNames
- Drug: pemetrexed
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- interventionNames
- Drug: docetaxel
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)
- description
- Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy * At least one prior chemotherapy for palliative therapy * Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Exclusion Criteria: * Concurrent administration of any other tumor therapy * Pregnant or breast feeding * Serious concomitant disorders * Inability or unwillingness to take folic acid or vitamin B12 supplementation
References
Publications (2)
- DERIVEDWu YL, Sun Y, Zhou CC, Zhang L, Yu SY, Ma SL, Han LL, Zhang XQ, Orlando M. Survival without common toxicity criteria grade 3/4 toxicity following second-line treatment with pemetrexed for nonsquamous non-small cell lung cancer in Chinese patients. Chin Med J (Engl). 2013;126(24):4624-8. PMID 24342300
- DERIVEDSun Y, Wu YL, Zhou CC, Zhang L, Zhang L, Liu XY, Yu SY, Jiang GL, Li K, Qin SK, Ma SL, Han L, Quinlivan M, Orlando M, Zhang XQ. Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: a randomized, open-label study. Lung Cancer. 2013 Feb;79(2):143-50. doi: 10.1016/j.lungcan.2012.10.015. Epub 2012 Nov 20. PMID 23182660