CA245-0001: BMS986489 + Chemo vs Atezolizumab + Chemo in Pts with SCLC
Research type
Research Study
Full title
A Randomized, Double-Blind, Multi center 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)
IRAS ID
1010950
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Clinicaltrials.gov Identifier
Research summary
TIGOS is a global study of a new cancer therapy called BMS-986489 (BMS-986012 + Nivolumab Fixed Dose Combination). The study will compare BMS-986489 with carboplatin plus etoposide (chemotherapy) against Atezolizumab with chemotherapy.
BMS-986012 is a type of medicine designed to help the body’s immune system fight a specific kind of lung cancer called small cell lung cancer (SCLC). It works by stimulating the immune system to attack and destroy the cancer cells. Studies have shown that when BMS-986012 is used together with another medicine called nivolumab (which also helps the immune system fight cancer), this combination (BMS-986489) may be effective in shrinking tumours and slowing down the cancer compared to using BMS-986012 alone. In this study researchers want to find out if this combination will help participants live longer.
There will be two groups:
Group A – Will receive BMS-986489 (BMS-986012 + Nivolumab) with Carboplatin plus Etoposide
Group B – Will receive Atezolizumab with Carboplatin plus Etoposide Atezolizumab (a immunotherapy drug)
Approximately 530 participants will take part in the study world-wide with up to 11 taking part in the UK. Participants and their hospital doctor will know what treatment they are on. Participants will be 18 years or older and have SCLC that is advanced (Stage IV) or has come back (recurred) after treatment with chemotherapy, radiotherapy or chemoradiotherapy.
The study has three parts: a screening period, treatment period, and a follow-up period. Participants will have two or more visits to the study hospital with the study team to undergo tests and review their health.
Participants will receive their treatment until their cancer gets worse, they choose to leave the study, the study doctor decides it is best for them to stop treatment or the study is ended. Follow-up visits will take place at the hospital after the treatment has ended.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0381
Date of REC Opinion
7 Jan 2025
REC opinion
Further Information Favourable Opinion