Small Cell Lung Cancer MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864
Conditions
Interventions
Product Name: BMS-986207
Product Code: BMS-986207
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: BMS-986207
Current Sponsor code: BMS-986207
Other descriptive name: B
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females; = 18 years of age or local age of majority. Histologically confirmed metastatic 1L Stage IV NSCLC of squamous or nonsquamous histology No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC Measureable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Participants must have a life expectancy of at least 3 months at the time of first dose. A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor tissue obtained during screening or prior to enrollment (within 3 months of enrollment and with no intervening systemic anticancer treatment between time of acquisition and enrollment). Samples must be sent to central laboratory and confirmed to be evaluable prior to treatment assignment or randomization. Assessment of tumor-cell PD-L1 expression by immunohistochemistry must be performed by central laboratory using pre-treatment tissue sample, and results must be reported prior to randomization (Part 2). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
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. Participants with untreated central nervous system metastases. Participants with leptomeningeal metastases (carcinomatous meningitis). Concurrent malignancy requiring treatment. Participants with an active, known, or suspected autoimmune disease. Prior treatment with anti-TIGIT, anti-PD-(L)1, anti- CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, tolerability, and DLTs of BMS-986207 in combination with nivolumab plus ipilimumab in participants with 1L Stage IV NSCLC (Part 1) To compare the PFS of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) versus nivolumab plus ipilimumab (Arm B) in participants with 1L Stage IV NSCLC expressing PD-L1 (Part 2) ;Secondary Objective: PFS of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) versus nivolumab plus ipilimumab (Arm B) in randomized participants and in subgroups defined by PD-L1 expression Safety and tolerability of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) and nivolumab plus ipilimumab (Arm B) in participants with 1L Stage IV NSCLC (Part 2) ORR and DOR of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) and nivolumab plus ipilimumab (Arm B) in randomized participants and in subgroups defined by PD-L1 expression OS of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) versus nivolumab plus ipilimumab (Arm B) in randomized participants and in subgroups defined by PD-L1 expression ;Primary end point(s): - Incidence of AEs meeting protocol-defined DLT criteria, AEs, TRAEs, SAEs, AEs leading to discontinuation, and deaths - PFS based on RECIST v1.1 by BICR;Timepoint(s) of evaluation of this end point: - Incidence of AEs meeting protocol-defined DLT criteria, AEs, TRAEs, SAEs, AEs leading to discontinuation, and deaths: ~ 4years -PFS based on RECIST v1.1 by BICR ~ 25 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -PFS based on RECIST v1.1 by BICR and Investigator’s assessment -Incidence of AEs, SAEs, AEs leading to discontinuation, and deaths -ORR and DOR based on RECIST v1.1 by BICR and Investigator’s assessment -OS ;Timepoint(s) of evaluation of this end point: -PFS based on RECIST v1.1 by BICR and Investigator’s assessment: ~ 25months -Incidence of AEs, SAEs, AEs leading to discontinuation, and deaths: ~ 4years -ORR and DOR based on RECIST v1.1 by BICR and Investigator’s assessment: ~25months -OS: ~30months | — |
Countries
Argentina, Australia, Belgium, Chile, France, Germany, Italy, Poland, Spain, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed