The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus \[vs.\] nonsquamous).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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) \[First 6 cycles (18 weeks)\]
ImClone Investigational Site
Anniston, Alabama, United States
ImClone Investigational Site
La Jolla, California, United States
ImClone Investigational Site
Orange, California, United States
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated \* 100.
Time frame: Randomization to measured progressive disease (PD) (up to 16.9 months)
Overall Survival (OS)
OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.
Time frame: Randomization to death due to any cause or censor (up to 30.4 months)
Progression-Free Survival (PFS)
PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.
Time frame: Randomization to PD or death due to any cause or censor (up to 16.9 months)
Time To Progression (TTP)
TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.
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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
ImClone Investigational Site
Orlando, Florida, United States
ImClone Investigational Site
Atlanta, Georgia, United States
ImClone Investigational Site
Chicago, Illinois, United States
ImClone Investigational Site
Chicago, Illinois, United States
ImClone Investigational Site
Albuquerque, New Mexico, United States
ImClone Investigational Site
New York, New York, United States
ImClone Investigational Site
New York, New York, United States
...and 2 more locations
Time frame: Randomization to months until PD or censor (up to 16.9 months)
Duration of Response
The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.
Time frame: Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)
Number of Participants With Adverse Events (AEs) or Deaths
Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Time frame: Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up
Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)
Time frame: Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy
Maximum Concentration (Cmax) of Cixutumumab at Study Day 1
Time frame: Day 1
Cmax of Cixutumumab for Cycle 1
Time frame: Week 1 (Cycle 1, Day 1)
Cmax of Cixutumumab for Cycle 3
Time frame: Week 7 (Cycle 3, Day 1)
Cmax of Cixutumumab Cycle 5
Time frame: Week 13 (Cycle 5, Day 1)
Minimum Concentration (Cmin) of Cixutumumab at Study Day 1
Time frame: Day 1
Cmin of Cixutumumab for Cycle 1
Time frame: Week 1 (Cycle 1, Day 1)
Cmin of Cixutumumab for Cycle 3
Time frame: Week 7 (Cycle 3, Day 1)
Cmin of Cixutumumab for Cycle 5
Time frame: Week 13 (Cycle 5, Day 1)