RightFit
RecruitingPhase 3

A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ 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 (TIGOS).

A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+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).

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people with small cell lung cancer that has spread widely. It compares BMS-986489 (atigotatug plus nivolumab) with atezolizumab as the first treatment, with both groups also getting the chemotherapy drugs carboplatin and etoposide. The study tests how well these treatments work and how safe they are.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have small cell lung cancer that has spread widely, called extensive-stage cancer.
  • Be well enough to do normal daily activities with little or no help.
  • Have at least one tumor outside the brain and nervous system that can be measured on a scan, such as a CT scan or MRI.
  • Other study rules for joining also apply.

Who can't join

  • Have already had certain treatments for extensive-stage small cell lung cancer.
  • Have cancer that has spread to the brain and is causing symptoms.
  • Have certain lung or heart diseases, infections, or other cancers.
  • Have certain autoimmune diseases, where the body's defense system attacks healthy cells.
  • Have peripheral sensory neuropathy, a type of nerve damage that affects feeling.
  • Other study rules may also prevent you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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/Exclusion criteria apply.

Study sites (20)

AL

AR

FL

GA

IL

MN

NC

ND

NM

OH

SD

TN

TX

VA

WA