The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer
Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers. The advanced stages are associated with poor survival rates, a median survival rate of approximately 3.9 months if left untreated. Angiogenesis is a process for wound healing and restoring blood flow to tissues after injury. It is the physiological process involving the growth of new blood vessels from pre-existing vessels. Angiogenesis may be promoted by growth factors and in diseases such as cancer, where growth factors are over expressed, the body loses the ability to maintain a balanced angiogenesis. This may embellish the existing supplies of blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer growth and survival. Ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the growth factor to form new blood vessels, thus reducing the blood supply to the cancer cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle.
200 milligrams per meter squared (mg/m\^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles.
Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.
ImClone Investigational Site
Beverly Hills, California, United States
ImClone Investigational Site
San Francisco, California, United States
ImClone Investigational Site
Aurora, Colorado, United States
ImClone Investigational Site
Percentage of Participants Who Are Progression-free (PFS) at 6 Months
Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
Time frame: 6 months
Summary of Participants Reporting Adverse Events
Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.
Time frame: Baseline up to 32.5 months
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])
Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.
Time frame: First dose to measured progressive disease or death due to any cause up to 32.5 months
Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
New York, New York, United States
ImClone Investigational Site
The Bronx, New York, United States
ImClone Investigational Site
San Antonio, Texas, United States
ImClone Investigational Site
Seattle, Washington, United States
ImClone Investigational Site
Cambridge, United Kingdom
ImClone Investigational Site
London, United Kingdom
Time frame: First dose up to 32.5 months
Overall Survival (OS) at 1 Year
Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.
Time frame: First dose to 1 year
Progression-free Survival (PFS)
Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy.
Time frame: First dose to measured progressive disease or death due to any cause, up to 32.5 months
Overall Survival (OS)
Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.
Time frame: First dose to death due to any cause, up to 32.5 months
Serum Anti-Ramucirumab Antibody Assessment
The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.
Time frame: Week 15 (Cycle 5)
Maximum Concentration of Ramucirumab (Cmax)
Time frame: Week 18 (Cycle 6), at 1-Hour Post End of Infusion