Phase 4
N=33
Chemotherapy for Patients With Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00380718 ↗Enrolled (actual)
33
Serious AEs
39.4%
Results posted
Oct 2009
Primary outcome: Primary: Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) — 0.182 proportion of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) |
0.182 | — |
| SECONDARY Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR]) |
0.545 | — |
| SECONDARY Overall Survival |
20.2 | — |
| SECONDARY Progression-Free Survival (PFS) |
6.9 | — |
| SECONDARY Duration of Response |
6.6 | — |
| SECONDARY Time to Treatment Failure |
2.9 | — |
| SECONDARY Time to Tumor Progression |
6.9 | — |
Summary
The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
- Patients' NSCLC must have progressed following one chemotherapy regimen for palliative therapy with or without subsequent targeted biological therapy
- Disease status must be that of measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria
- Concurrent administration of any other tumor therapy
- Pregnancy or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Data sourced from ClinicalTrials.gov (NCT00380718). 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.