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NCT Number: NCT06646276

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ 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).

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.

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Key information

Conditions

Extensive-stage Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0079, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986489 (BMS-986012+Nivolumab)

Biological

Specified dose on specified days

Atezolizumab

Biological

Specified dose on specified days

carboplatin

Drug

Specified dose on specified days

etoposide

Drug

Specified dose on specified days

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 5 years

Secondary outcomes

  1. 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).

    Time frame: Up to 5 years

  2. Number of participants with Adverse Events (AEs)

    Time frame: Up to 135 days after last treatment

  3. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to 135 days after last treatment

  4. Number of Participants with Adverse Events (AEs) leading to discontinuation and death

    Time frame: Up to 135 days after last treatment

  5. Objective Response (OR)

    Time frame: Up to 5 years

  6. Duration of Response (DOR)

    Time frame: Up to 5 years

  7. Progression Free Survival (PFS)

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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).

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Oct 17, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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