Extensive-Stage Small Cell Lung Cancer
Conditions
Keywords
BMS-986489, BMS-986012, Extensive-Stage Small Cell Lung Cancer, Etoposide, Carboplatin, Nivolumab, TIGOS, fucGM1, SCLC, ES-SCLC, atigotatug
Brief summary
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
Interventions
BIOLOGICALBMS-986489 (Atigotatug+Nivolumab)
Specified dose on specified days
BIOLOGICALAtezolizumab
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
DRUGEtoposide
Specified dose on specified days
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
* Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). * Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale. * Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system
Exclusion criteria
* Participants have already received certain types of treatment for extensive stage small cell lung cancer * Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to definitive deterioration (TTDD)based on the LCSS ASBI defined as the time from randomization until a definitive clinically meaningful decline (≥ 10 point increase from baseline in LCSS ASBI score). | Up to 5 years |
| Number of participants with Adverse Events (AEs) | Up to 135 days after last treatment |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 135 days after last treatment |
| Number of Participants with Adverse Events (AEs) leading to discontinuation and death | Up to 135 days after last treatment |
| Objective Response (OR) | Up to 5 years |
| Duration of Response (DOR) | Up to 5 years |
| Progression Free Survival (PFS) | Up to 5 years |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, India, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, South Korea, Spain, Switzerland, Turkey (Türkiye), 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