Phase 2
N=64
Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00191139 ↗Enrolled (actual)
64
Serious AEs
48.4%
Results posted
Dec 2009
Primary outcome: Primary: 2-Year Survival — 40.6; 55.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- gemcitabine (Drug); docetaxel (Drug); cisplatin (Drug); etoposide (Drug); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-Year Survival |
40.6; 55.7 | — |
| SECONDARY Number of Patients With Overall Tumor Response |
24; 27 | — |
| SECONDARY Progression-Free Survival |
162.5; 408.0 | 0.08 |
| SECONDARY Overall Survival |
492.5; 899.0 | 0.38 |
| SECONDARY Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization |
8; 5; 10; 9; 2; 8 | — |
Summary
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.
Eligibility Criteria
Inclusion Criteria
- histologic or cytologic proof of single primary non-small cell lung cancer
- No prior chemotherapy or radiation therapy
- no prior malignancy
Exclusion Criteria
- pregnancy or breastfeeding
- serious concomitant systemic disorder
- unintentional weight loss greater than 10%
Data sourced from ClinicalTrials.gov (NCT00191139). 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.