Lung Cancer - Non Small Cell Clinical Trial
Official title:
A Randomized, Open-Label, Phase 2 Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Subjects With Recurrent/Stage IV Non-Squamous, Non-Small Cell Lung Cancer Who Have Not Progressed After Four Cycles of a Platinum-Based First Line Chemotherapy
The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.
| Status | Terminated |
| Enrollment | 9 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: - Non-Squamous, Non-Small Cell Lung Cancer - Recurrent/Stage IV Non-small cell lung cancer (NSCLC) - Eastern Cooperative Oncology Group (ECOG) 0 or 1 - Not progressing after 4 cycles of a platinum-based first line chemotherapy Exclusion Criteria: - Brain Metastases (unless stable) - Autoimmune Diseases |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Local Institution | Brugge | |
| Belgium | Local Institution | Sint Niklaas | |
| France | Local Institution | Paris | |
| Germany | Local Institution | Hamburg | |
| Germany | Local Institution | Heidelberg | |
| Spain | Local Institution | Benidorm-Alicante | |
| United States | Blue Ridge Cancer Care | Christiansburg | Virginia |
| United States | Medical And Surgical Specialists, Llc | Galesburg | Illinois |
| United States | Marin Specialty Care, Inc. | Greenbrae | California |
| United States | Meritus Center For Clinical Research | Hagerstown | Maryland |
| United States | Carolina Biooncology Institute | Huntersville | North Carolina |
| United States | Montgomery Cancer Center | Mount Sterling | Kentucky |
| United States | Quincy Medical Group | Quincy | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Belgium, France, Germany, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival of Participants During the Study - All Treated Participants | Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed. | Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started | No |
| Secondary | Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants | Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose. | Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started. | No |
| Secondary | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study. | Day 1 to Date of last patient, last visit, approximately 7 months after study started. | Yes |