Lung Cancer - Non Small Cell
Conditions
Brief summary
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.
Interventions
BIOLOGICALIpilimumab
Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion
BIOLOGICALPemetrexed
IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival of Participants During the Study - All Treated Participants | Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants | Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started. | 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. |
| Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | Day 1 to Date of last patient, last visit, approximately 7 months after study started. | 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. |
Countries
Belgium, France, Germany, Spain, United States
Participant flow
Recruitment details
Study started July 2012 and completed February 2013. After 9 participants enrolled, the study was terminated for administrative reasons unrelated to adverse events (AEs) or expectation of efficacy associated with either ipilimumab or pemetrexed.
Pre-assignment details
9 participants enrolled; 8 participants randomized; 1 participant not randomized due to disease progression and death.
Participants by arm
| Arm | Count |
|---|---|
| Ipilimumab 10 mg/kg Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion. | 6 |
| Pemetrexed 500 mg/m^2 Pemetrexed: IV solution, IV, 500 mg/m\^2, Once every 3 weeks during Treatment Phase, 10 minute infusion. | 2 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Disease Progression | 4 | 2 |
| Overall Study | Study Drug Toxicity | 1 | 0 |
Baseline characteristics
| Characteristic | Ipilimumab 10 mg/kg | Pemetrexed 500 mg/m^2 | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8.85 | 61.0 years STANDARD_DEVIATION 1.41 | 62.3 years STANDARD_DEVIATION 7.54 |
| Age, Customized Greater than, equal to (>=) 65 years | 2 participants | 0 participants | 2 participants |
| Age, Customized Less than (<) 65 years | 4 participants | 2 participants | 6 participants |
| Eastern Cooperative Oncology Group Performance Status ECOG PS 0 | 3 participants | 1 participants | 4 participants |
| Eastern Cooperative Oncology Group Performance Status ECOG PS 1 | 3 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 2 / 2 |
| serious Total, serious adverse events | 5 / 6 | 1 / 2 |
Outcome results
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.
Time frame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Population: All participants who received at least one dose of either study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab 10 mg/kg | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 0.9 months | 1 participants |
| Ipilimumab 10 mg/kg | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 1.8 months | 1 participants |
| Ipilimumab 10 mg/kg | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 3.9 months+(censored) | 1 participants |
| Ipilimumab 10 mg/kg | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 4.4 months+(censored) | 2 participants |
| Ipilimumab 10 mg/kg | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 4.6 months+(censored) | 1 participants |
| Ipilimumab 10 mg/kg | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 5.4 months+(censored) | 0 participants |
| Pemetrexed 500 mg/m^2 | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 4.6 months+(censored) | 0 participants |
| Pemetrexed 500 mg/m^2 | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 0.9 months | 0 participants |
| Pemetrexed 500 mg/m^2 | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 4.4 months+(censored) | 0 participants |
| Pemetrexed 500 mg/m^2 | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 1.8 months | 0 participants |
| Pemetrexed 500 mg/m^2 | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 5.4 months+(censored) | 2 participants |
| Pemetrexed 500 mg/m^2 | Overall Survival of Participants During the Study - All Treated Participants | Overall Survival 3.9 months+(censored) | 0 participants |
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.
Time frame: Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.
Population: All participants who were randomized and treated with at least one dose of either study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab 10 mg/kg | Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants | Death within 30 Days of Last Dose | 1 participants |
| Ipilimumab 10 mg/kg | Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants | Death within 32 Days of Last Dose | 1 participants |
| Pemetrexed 500 mg/m^2 | Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants | Death within 30 Days of Last Dose | 0 participants |
| Pemetrexed 500 mg/m^2 | Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants | Death within 32 Days of Last Dose | 0 participants |
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.
Time frame: Day 1 to Date of last patient, last visit, approximately 7 months after study started.
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ipilimumab 10 mg/kg | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | Deaths | 2 participants |
| Ipilimumab 10 mg/kg | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | SAEs | 5 participants |
| Ipilimumab 10 mg/kg | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | AEs | 6 participants |
| Ipilimumab 10 mg/kg | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | AEs leading to discontinuation | 1 participants |
| Pemetrexed 500 mg/m^2 | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | AEs leading to discontinuation | 0 participants |
| Pemetrexed 500 mg/m^2 | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | Deaths | 0 participants |
| Pemetrexed 500 mg/m^2 | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | AEs | 2 participants |
| Pemetrexed 500 mg/m^2 | Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants | SAEs | 1 participants |