A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05005273
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Nivolumab - Arm B Ipilimumab - Arm B Nivolumab - Arm A Ipilimumab - Arm B Placebo - Arm A BMS-986207 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.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.
Trial Locations
- Locations (68)
Local Institution - 0044
🇫🇷Pessac, France
Local Institution - 0013
🇫🇷Suresnes, France
Local Institution - 0042
🇫🇷Toulon, France
Local Institution - 0062
🇦🇷Buenos Aires, Argentina
Local Institution - 0049
🇺🇸Brooklyn, New York, United States
Local Institution - 0021
🇦🇷Buenos Aires, Argentina
Local Institution
🇮🇹Milano, Italy
Local Institution - 0045
🇺🇸Pensacola, Florida, United States
Local Institution - 0074
🇺🇸Edgewood, Kentucky, United States
Local Institution - 0063
🇦🇺Orange, New South Wales, Australia
Local Institution - 0036
🇺🇸Orange City, Florida, United States
Local Institution - 0043
🇧🇪Mons, Belgium
Local Institution - 0037
🇫🇷Limoges, France
Local Institution - 0022
🇩🇪Frankfurt, Hessen, Germany
Local Institution - 0048
🇦🇷Buenos Aires, Argentina
Local Institution - 0064
🇮🇱Haifa, Israel
Local Institution - 0056
🇦🇺Wahroonga, New South Wales, Australia
Local Institution - 0001
🇮🇹Padova, Italy
Local Institution - 0024
🇵🇱Bydgoszcz, Poland
Local Institution - 0003
🇵🇱Lodz, Poland
Local Institution - 0038
🇵🇱Otwock, Poland
Local Institution - 0051
🇺🇸Fountain Valley, California, United States
Local Institution - 0058
🇵🇱Szczecin, Poland
Local Institution - 0080
🇺🇸Tucson, Arizona, United States
Local Institution - 0070
🇺🇸Fort Myers, Florida, United States
Local Institution - 0081
🇺🇸Boise, Idaho, United States
Local Institution - 0068
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0077
🇺🇸Coeur d'Alene, Idaho, United States
Local Institution - 0034
🇧🇪Mechelen, Antwerpen, Belgium
Local Institution - 0040
🇧🇪Charleroi, Belgium
Local Institution - 0030
🇫🇷Nantes, France
Local Institution - 0016
🇫🇷Rouen, France
Local Institution - 0031
🇫🇷Saint Priest en Jarez, France
Local Institution - 0005
🇩🇪Gauting, Bayern, Germany
Local Institution - 0017
🇩🇪Gera, Germany
Local Institution - 0023
🇩🇪Muenchen, Germany
Local Institution - 0033
🇪🇸Majadahonda, Madrid, Spain
Local Institution - 0059
🇩🇪Wiesbaden, Germany
Local Institution - 0078
🇮🇱Jerusalem, Israel
Local Institution - 0061
🇮🇱Jerusalem, Israel
Local Institution - 0079
🇮🇱Jerusalem, Israel
Local Institution - 0028
🇮🇹Naples, Italy
Local Institution - 0041
🇪🇸Alicante, Spain
Local Institution - 0026
🇪🇸Barcelona, Spain
Local Institution - 0075
🇪🇸Barcelona, Spain
Local Institution - 0006
🇪🇸Barcelona, Spain
Local Institution - 0046
🇪🇸Jaen, Spain
Local Institution - 0032
🇪🇸Madrid, Spain
Local Institution - 0076
🇹🇷Istanbul, Turkey
Local Institution - 0066
🇹🇷Istanbul, Turkey
Local Institution - 0065
🇹🇷Izmir, Turkey
Local Institution - 0067
🇹🇷Samsun, Turkey
Local Institution - 0073
🇺🇸Gainesville, Florida, United States
Local Institution - 0002
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0039
🇮🇹Monza, MB, Italy
Local Institution - 0020
🇮🇹Rozzano, MI, Italy
Local Institution - 0072
🇹🇷Yuregir, Turkey
Local Institution - 0050
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0009
🇦🇷Pergamino, Buenos Aires, Argentina
Local Institution - 0011
🇦🇷Buenos Aires, Argentina
Local Institution - 0035
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0019
🇧🇪Sint-Niklaas, Belgium
Local Institution - 0015
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0052
🇦🇺Warrnambool, Victoria, Australia
Local Institution - 0057
🇦🇷San Juan, Argentina
Local Institution - 0054
🇦🇷Rosario, Santa FE, Argentina
Local Institution - 0012
🇺🇸Charleston, South Carolina, United States
Local Institution - 0053
🇺🇸Milwaukee, Wisconsin, United States