At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, Cisplatin, and 3 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 64 participants across 12 sites.
Detailed Summary
The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Study Details
Timeline
Interventions
1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle \[First 6 cycles (18 weeks)\]
75 mg/m\^2 on Day 1 of each cycle \[First 6 cycles (18 weeks)\]
6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) \[First 6 cycles (18 weeks)\]
400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter \[First 6 cycles (18 weeks)\]
10 mg/kg IV infusion, administered once every 2 weeks (Maintenance therapy)
500 mg/m\^2 IV infusion, administered once every 2 weeks (Maintenance therapy)
Area under the curve (AUC) = 5, Day 1 of each cycle \[First 6 cycles (18 weeks)\] \*Carboplatin will be replaced by Cisplatin