Non-Small-Cell Lung Carcinoma
Conditions
Keywords
Non-Small Lung Cancer
Brief summary
The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.
Interventions
DRUGCetuximab + platinum + gemcitabine
Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.
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
* Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy. * Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva). * Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease. * Must be able to carry out work of light or sedentary nature (e.g. light house work, office work). * It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.
Exclusion criteria
* Women who are pregnant or breastfeeding. * Women with a positive pregnancy test on enrollment or prior to study drug administration. * Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial). * Symptomatic or uncontrolled metastases in the central nervous system (CNS). * Peripheral neuropathy. * Inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or a hemoglobin level \< 9g/dL. * Inadequate liver function. * Inadequate kidney function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor response per treatment arm | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control, symptom response, symptomatic progression, & progression free survival. | — |
Countries
Canada, United States
Outcome results
None listed