Lung Cancer (NSCLC)
Conditions
Brief summary
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
Interventions
BIOLOGICALPaclitaxel
BIOLOGICALCarboplatin
BIOLOGICALIpilimumab
OTHERPlacebo
0.9% sodium chloride injection, USP, or 5% dextrose injection
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone * Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification) * At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area * Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Exclusion criteria
* Brain metastases * Malignant pleural effusion that is recurrent * Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy | Approximately 43 months post study start | OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival of All Randomized Participants | Approximately 43 months post study start | OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive. |
| Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria | Approximately 43 months post study start | PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization. |
Countries
China, Germany, Hungary, Poland, Singapore, South Korea
Participant flow
Pre-assignment details
342 participants enrolled, 295 were randomized to ipilimumab (148) and placebo arms (147). After chemotherapy, double blinded study treatment, which was the focus of the study, was started.Of all randomized participants, only 98 (ipilimumab arm) and 106 (placebo arm) participants received at least one dose of blinded study therapy.
Participants by arm
| Arm | Count |
|---|---|
| Ipi + PAC/CAR Ipilumumab + paclitaxel/Carboplatin | 98 |
| Placebo + PAC/CAR Placebo + Carboplatin/Paclitaxel | 106 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Reason By Sponsor | 0 | 2 |
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Death | 23 | 20 |
| Overall Study | Disease Progression | 13 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Maximum Clinical Benefit | 1 | 0 |
| Overall Study | Other | 53 | 67 |
| Overall Study | Study Drug Toxicity | 2 | 0 |
| Overall Study | Subject Requested to Discontinue | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 7 |
Baseline characteristics
| Characteristic | Placebo + PAC/CAR | Total | Ipi + PAC/CAR |
|---|---|---|---|
| Age, Continuous | 59.8 Years STANDARD_DEVIATION 8.22 | 60.3 Years STANDARD_DEVIATION 7.61 | 60.9 Years STANDARD_DEVIATION 6.89 |
| Race/Ethnicity, Customized Chinese | 80 Participants | 161 Participants | 81 Participants |
| Race/Ethnicity, Customized Non-Chinese | 26 Participants | 43 Participants | 17 Participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 93 Participants | 180 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 98 | 9 / 106 |
| other Total, other adverse events | 91 / 98 | 87 / 106 |
| serious Total, serious adverse events | 40 / 98 | 33 / 106 |
Outcome results
Primary
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Time frame: Approximately 43 months post study start
Population: All participants who were randomized and received at least 1 dose of blinded study therapy.The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this primary endpoint
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipi + PAC/CAR | Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy | NA months |
| Placebo + PAC/CAR | Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy | NA months |
Secondary
Overall Survival of All Randomized Participants
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Time frame: Approximately 43 months post study start
Population: All participants who were randomized to a treatment arm. The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this secondary endpoint
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipi + PAC/CAR | Overall Survival of All Randomized Participants | NA months |
| Placebo + PAC/CAR | Overall Survival of All Randomized Participants | NA months |
Secondary
Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria
PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Time frame: Approximately 43 months post study start
Population: All participants who were randomized and received at least 1 dose of blinded study therapy.The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this secondary endpoint
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipi + PAC/CAR | Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria | NA months |
| Placebo + PAC/CAR | Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria | NA months |