A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Multinational, randomized, multicenter, open-label Phase 3 study of 634 patients with
advanced, nonsquamous (Stage IV) NSCLC. Patients will be randomized on a 1:1 basis to
receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in
study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in 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 (computed tomography or magnetic resonance
imaging) of disease status 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 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.
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 474 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 30 months
E-mail: ClinicalTrials@ ImClone.com
Australia: Department of Health and Ageing Therapeutic Goods Administration
|ImClone Investigational Site||New York, New York 10021|