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).

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986489 (Atigotatug+Nivolumab)

    Biological/Vaccine

    Specified dose on specified days

  • Atezolizumab

    Biological/Vaccine

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Etoposide

    Drug

    Specified dose on specified days

Treatment groups

530 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 3 interventions
Group B: Arm BActive comparator 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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