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RecruitingLast updated: 31 March 2025

TIGOS: This study is recruiting people with extensive-stage small cell lung cancer to evaluate how effective a new combination treatment (called BMS-986489) is compared to immunotherapy when given in addition to chemotherapyA 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).

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

TIGOS

Clinical summary

Summary

The purpose of this study is to compare the efficacy and safety of BMS-986489, which is a fixed dose combination of a monoclonal antibody that targets fucosyl-GM1 and Nivolumab immunotherapy, with that of Atezolizumab immunotherapy when given in addition to chemotherapy (carboplatin + etoposide).

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm A (Experimental), participants will receive the combination treatment BMS-986489 plus carboplatin and etoposide.

In Arm B (Active Comparator), participants will receive Atezolizumab immunotherapy plus carboplatin and etoposide.

Conditions

This trial is treating people with extensive-stage small cell lung cancer who haven't had prior treatment

Eligibility

Inclusion

  • 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

  • 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/Exclusion criteria apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bristol-Myers Squibb

Scientific 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).

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