Clinical trial · Interventional
Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT00520676CI-TRIAL-00005343completedPhase 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 combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pemetrexed plus carboplatin
- description
- Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum
- interventionNames
- Drug: pemetrexed
- Drug: carboplatin
- type
- ACTIVE_COMPARATOR
- label
- docetaxel plus carboplatin
- description
- Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
- interventionNames
- Drug: docetaxel
- Drug: carboplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment * Easter Cooperative Oncology Group (ECOG) performance status 0 to 2 * Estimated life expectancy of at least 8 weeks Exclusion Criteria: * Known or suspected brain metastases * Concurrent administration of any other tumor therapy * Serious concomitant disorders * Pregnancy or breast feeding * Inability or unwillingness to take folic acid or vitamin B12 supplementation
References
Publications (2)
- DERIVEDLoureiro H, Kolben TM, Kiermaier A, Ruttinger D, Ahmidi N, Becker T, Bauer-Mehren A. Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials. JCO Clin Cancer Inform. 2023 Sep;7:e2300062. doi: 10.1200/CCI.23.00062. PMID 37922432
- DERIVEDPereira JR, Cheng R, Orlando M, Kim JH, Barraclough H. Elderly subset analysis of randomized phase III study comparing pemetrexed plus carboplatin with docetaxel plus carboplatin as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. Drugs R D. 2013 Dec;13(4):289-96. doi: 10.1007/s40268-013-0032-6. PMID 24277116