Phase 3
N=211
Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00391274 ↗Enrolled (actual)
211
Serious AEs
10.6%
Results posted
Mar 2010
Primary outcome: Primary: Overall Survival — 11.7; 12.2; 11.4; 11.5 months — p=0.4921
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pemetrexed (Drug); docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
11.7; 12.2; 11.4; 11.5 | 0.4921 |
| SECONDARY Overall Tumor Response |
0; 0; 10; 4; 33; 46 | 0.1326 |
| SECONDARY Progression-Free Survival (PFS) |
2.8; 3.1 | 0.7704 |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Pharmacology Toxicity |
1; 0; 7; 3; 4; 21 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00391274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.