Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, NSCLC, BMS-986207, Nivolumab, Opdivo, Ipilimumab, Yervoy
Brief summary
The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).
Interventions
DRUGNivolumab
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
DRUGBMS-986207
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology * No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC * Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment * Life expectancy of at least 3 months at the time of first dose
Exclusion criteria
* Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded * Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible. * Untreated central nervous system metastases * Leptomeningeal metastases (carcinomatous meningitis) * Concurrent malignancy requiring treatment * Active, known, or suspected autoimmune disease * Interstitial lung disease * Uncontrolled or significant cardiovascular disease Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival by BICR | From first dose to progression or death, 2.3 months | PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) by BICR | From first dose to progression or death, 2.3 months | ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Overall Response Rate (ORR) by Investigator | From first dose to progression or death, 2.3 months | ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Progression Free Survival by Investigator | From first dose to progression or death, 2.3 months | PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. |
| Overall Survival (OS) | From randomization to time of death, 2.3 months | OS is defined as the time from randomization to the time of death due to any cause. |
| Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | From first dose to progression or death, 2.3 months | — |
| Duration of Response (DOR) by Investigator | From first dose to progression or death, 2.3 months | DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Countries
Argentina, Australia, Belgium, Chile, France, Germany, Israel, Italy, Poland, Spain, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
1 participant randomized and treated
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W | 1 |
| Treatment 2 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Terminated | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment 1 | Treatment 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 1 / 1 | 0 / 0 |
Outcome results
Primary
Progression Free Survival by BICR
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time frame: From first dose to progression or death, 2.3 months
Population: BICR evaluation did not occur so 0 participants were analyzed for this endpoint.
Secondary
Duration of Response (DOR) by Investigator
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose to progression or death, 2.3 months
Population: All Treated Participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment 1 | Duration of Response (DOR) by Investigator | NA Months |
Secondary
Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Time frame: From first dose to progression or death, 2.3 months
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment 1 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | Adverse Events | 0 Participants |
| Treatment 1 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | Serious Adverse Events | 1 Participants |
| Treatment 1 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | AEs leading to discontinuation | 0 Participants |
| Treatment 1 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | Deaths | 1 Participants |
| Treatment 2 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | Deaths | 0 Participants |
| Treatment 2 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | Adverse Events | 0 Participants |
| Treatment 2 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | AEs leading to discontinuation | 0 Participants |
| Treatment 2 | Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. | Serious Adverse Events | 0 Participants |
Secondary
Overall Response Rate (ORR) by BICR
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose to progression or death, 2.3 months
Population: BICR evaluation did not occur so 0 participants were analyzed for this endpoint.
Secondary
Overall Response Rate (ORR) by Investigator
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose to progression or death, 2.3 months
Population: 0 participants met the criteria for to be considered CR and PR, 0 participants were analyzed for this endpoint
Secondary
Overall Survival (OS)
OS is defined as the time from randomization to the time of death due to any cause.
Time frame: From randomization to time of death, 2.3 months
Population: All Treated Participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment 1 | Overall Survival (OS) | 2.3 Months |
Secondary
Progression Free Survival by Investigator
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time frame: From first dose to progression or death, 2.3 months
Population: All Treated Participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment 1 | Progression Free Survival by Investigator | 2.3 Months |