Conditions: Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 72
Healthy volunteers: no

Brief summary:
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

Detailed description:
Upon determination of eligibility, patients will be receive:

* Pemetrexed + Gemcitabine

Arms:
arm 1: Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.

Interventions: intervention 1: Pemetrexed intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 500mg/m2 IV over 10 min, Day 1, prior to gemcitabine intervention 2: 1500mg/m2, 30min IV

Protocol document: