Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Squamous Non-Small Cell Lung Cancer (NSCLC), Non-squamous Non-Small Cell Lung Cancer (NSCLC), Immunotherapy, Bispecific antibody, Imzokitug, Anti-CCR8 monoclonal antibody
Brief summary
The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Interventions
DRUGPumitamig
Specified dose on specified days
DRUGImzokitug
Specified dose on specified days
DRUGPemetrexed
Specified dose on specified days
DRUGCisplatin
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
DRUGPaclitaxel
Specified dose on specified days
DRUGInfliximab
Specified dose on specified days
DRUGVedolizumab
Specified dose on specified days
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
* Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition. * Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site. * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion criteria
* Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated. * Participants must not have prior treatment with immuno-oncology therapies. * Participants must not have untreated central nervous system (CNS) metastases. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) | Up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 90 days after discontinuation of study treatment |
| Number of participants with serious adverse events (SAEs) | Up to 90 days after discontinuation of study treatment |
| Number of participants with treatment-related AEs | Up to 90 days after discontinuation of study treatment |
| Number of participants with treatment-related SAEs | Up to 90 days after discontinuation of study treatment |
| Number of participants with AEs leading to discontinuation | Up to 90 days after discontinuation of study treatment |
| Number of deaths | Up to 90 days after discontinuation of study treatment |
| Progression free survival (PFS) by investigator (per RECIST v1.1) | Up to approximately 4 years |
| Overall survival (OS) | Up to approximately 4 years |
| Duration of response (DOR) by investigator (per RECIST v1.1) | Up to approximately 4 years |
| Time to recurrence (TTR) by investigator (per RECIST v1.1) | Up to approximately 4 years |
Countries
Argentina, Australia, Brazil, Chile, China, France, Germany, Italy, Romania, Spain, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed