A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Approximately 1080 patients (age ≥ 18 years) with histologically- or
cytologically-confirmed, stage iv squamous-cell NSCLC, who have received no prior therapy
for metastatic disease, will be randomized on a 1:1 basis to receive first-line necitumumab
(IMC-11F8) plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or
gemcitabine-cisplatin chemotherapy alone in study Arm B. Baseline radiographic assessment of
disease will be performed within 21 days prior to randomization (first treatment will be
administered within 7 days following randomization). Patients will undergo radiographic
assessment of disease status (computed tomography or magnetic resonance imaging) every 6
weeks (± 3 days), until there is radiographic documentation of progressive disease (PD).
Chemotherapy will continue for a maximum of six cycles in each arm (or until there is
radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or
withdrawal of consent); patients in Arm A only will continue to receive necitumumab
(IMC-11F8) until there is radiographic documentation of PD, toxicity requiring cessation,
protocol noncompliance, or withdrawal of consent.
After the end-of-study-visit (following PD), follow-up information regarding further
anticancer treatment and survival will be collected every 2 months (± 7 days). For patients
who discontinue study for reasons other than PD (eg, symptomatic deterioration), information
on disease progression will also be collected until PD is documented. Follow-up will
continue as long as the patient is alive, or until the end of the trial.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Kaplan-Meier Estimate for Overall survival time (OS)
Overall survival time is measured as randomization to date of death from any cause. Participants who are alive when the study achieves 844 deaths or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive.
Approximately 31 months
No
E-mail: ClinicalTrials @ImClone.com
Study Director
ImClone LLC
Australia: Department of Health and Ageing Therapeutic Goods Administration
13909
NCT00981058
January 2010
December 2014
Name | Location |
---|---|
ImClone Investigational Site | Indianapolis, Indiana 46202 |
ImClone Investigational Site | New York, New York 10021 |
ImClone Investigational Site | St. Charles, Missouri 63301 |
ImClone Investigational Site | Bakersfield, California 93309 |
ImClone Investigational Site | Decatur, Illinois 62526 |
ImClone Investigational Site | Louisville, Kentucky 40202 |
ImClone Investigational Site | Baltimore, Maryland 21204 |
ImClone Investigational Site | Cleveland, Ohio 44134 |
ImClone Investigational Site | Memphis, Tennessee 38104 |
ImClone Investigational Site | Norfolk, Virginia 23502 |
ImClone Investigational Site | Little Rock, Arkansas 72205 |
ImClone Investigational Site | Philadelphia, Pennsylvania 19107 |
ImClone Investigational Site | Tucson, Arizona 85712 |
ImClone Investigational Site | Kansas City, Kansas 66160 |
ImClone Investigational Site | Grand Island, Nebraska 68803 |