Non-Small Cell Lung Cancer
Conditions
Brief summary
Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.
Interventions
DRUGgemcitabine
1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles
DRUGCisplatin
75 mg/m2, IV, q 21 days x 3 cycles
PROCEDUREsurgery
surgery
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main inclusion Criteria: * Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA. * ECOG Performance Status of 0 - 1 * Bidimensionally measurable disease or evaluable disease * Adequate organ function Main
Exclusion criteria
* Have greater than Grade 1 neuropathy - motor/sensory * Significant history of cardiac disease * Pleural effusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | baseline to measure progressive disease |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | baseline to measured progressive disease |
| Pathologic response rate of tissue samples | baseline, post chemotherapy, post surgery |
| Pharmacology toxicity | every cycle |
| To compare the survival and sites of relapse in the two study arms. | baseline to progressive disease |
Countries
Belgium, Bosnia and Herzegovina, Bulgaria, Egypt, Estonia, Germany, Hungary, Italy, Lithuania, Poland, Romania, Saudi Arabia, Slovakia, Sweden, Taiwan
Outcome results
None listed