Phase 2
Completed N=226
To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00191191 ↗Enrolled (actual)
226
Serious AEs
17.8%
Results posted
Nov 2009
Primary outcomePrimary: Best Overall Response — 0; 0; 20; 16 participants
Summary
To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response |
0; 0; 20; 16; 40; 34 | — |
| SECONDARY Duration of Response |
4.9; 3.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.0; 2.5 | — |
| SECONDARY Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) |
77.0; 75.0; -1.5; -3.7; 78.9; 73.9 | — |
| SECONDARY Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS) |
71.5; 69.6; 3.0; 0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical stage III or IV
- Previously treated with one or two chemotherapeutic regimens
- Performance status: 0-2
Exclusion Criteria
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Data sourced from ClinicalTrials.gov (NCT00191191). 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. Informational only — not medical advice.