Purpose of this Study
We are doing this study to find out if an experimental drug called BMS-986489 (the study drug) is a safe and effective option for patients with extensive-stage small cell lung cancer (ES-SCLC). We want to find out how well it works in comparison to the usual therapy for this diagnosis.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with SCLC
- Have extensive-stage disease
- Are eligible to receive a platinum-based chemotherapy regimen
- Do not have any other malignancy aside from SCLC
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups.
- Arm A: If you are assigned to this group, you will get a single infusion of the study drug in combination with chemotherapy (carboplatin plus etoposide) every 3 weeks. After the first 12 weeks (4 cycles of treatment), you will get the study drug on its own every 4 weeks.
- Arm B: If you are assigned to this group, you will get a single infusion of atezolizumab in combination with chemotherapy (carboplatin plus etoposide) every 12 weeks. After the first 12 weeks, you will get atezolizumab on its own every 4 weeks.
Locations
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Randomized, Double-Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012 + Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide vs Atezolizumab in Combination with Carboplatin plus Etoposide as First-line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer (TIGOS)
Principal Investigator
Neal
Ready
Protocol Number
PRO00117304
NCT ID
NCT06646276
Phase
III
Enrollment Status
Pending Open to Enrollment