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TIGOS Study Information

Learn more about the TIGOS / CA245-0001 study and study procedures

TIGOS clinical Study logo

TIGOS is a Phase 3, double-blind, randomized clinical trial comparing the safety and efficacy of BMS-986489 in combination with chemotherapy induction followed by BMS-986489 maintenance, or atezolizumab in combination with chemotherapy induction followed by atezolizumab maintenance in ES-SCLC.

The investigational treatment, BMS-986489, is a fixed-dose combination of nivolumab and atigotatug, which is a fully humanized immunoglobulin G1 (IgG1) monoclonal antibody in clinical development that potentially targets tumors expressing fuc-GM1. It confers higher affinity for Fc receptors, resulting in enhanced antibody-dependent cell-mediated cytotoxicity (ADCC).

BMS-986489 may provide clinical benefit to participants with SCLC by combining the immune-based mechanisms of action of both compounds. It is expected that combinations of this investigational immunotherapy and chemotherapy can be used to achieve long-lasting anticancer responses in the treatment of SCLC.

TIGOS is a Phase 3, double-blind, randomized clinical trial comparing the safety and efficacy of

Randomized Therapy 1

BMS-986489 + chemotherapy induction

nivolumab and Atigotatug +
chemotherapy induction + maintenance

vs

Randomized Therapy 2

atezolizumab + chemotherapy induction

atezolizumab + chemotherapy induction + maintenance  

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Key Inclusion Criteria

  • Be at least 18 years old at the time of signing the informed consent form
  • Must have a histologically or cytologically confirmed diagnosis of SCLC and confirmation of extensive-stage. Participants who have received chemotherapy/chemoradiotherapy for limited-stage SCLC are eligible if treatment was completed at least 6 months prior to randomization.
  • Have at least one measurable lesion outside the central nervous system (CNS) confirmed on imaging. Participants with CNS metastases are eligible if asymptomatic or previously treated.
  • Have an ECOG performance status of 0 or 1.
  • Must be eligible to receive platinum-based chemotherapy regimen and anti-PD(L)-1-based regimens as per locally approved drug labels and institutional guidelines.
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Key Exclusion Criteria

  • Participants who have received the following prior treatments are not eligible to participate:
    • Prior treatment for extensive-stage SCLC.
    • Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways.
    • Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fucosyl-GM1.
  • Participants with untreated and symptomatic brain metastases are not eligible to participate.
  • Other Conditions:
    • Leptomeningeal metastases.
    • Malignancy-related superior vena cava syndrome that requires urgent radiation or may require urgent radiation in the immediate future.
    • Pleural effusions that cannot be controlled with standard interventions.
    • Concurrent malignancy.
    • Grade 2+ peripheral sensory neuropathy.
    • Active, known, or suspected autoimmune disease.
  • Women who are pregnant or breastfeeding are not eligible to participate.

*Other protocol-defined inclusion-exclusion criteria may apply

What are the endpoints?

  1. The Primary Endpoint is Overall Survival.
  2. The secondary endpoints include Time Until Definitive Deterioration, Objective Response, Objective Response Rate, Duration of Response, and Progression-Free Survival.

What is the timeline of the study?

  1. Screening (28-day window): Eligibility will be established according to the key eligibility criteria found below. For additional information on screening procedures, please ask the study staff.
  2. Study treatment period: this involves an initial induction phase, followed by a maintenance phase. Patients will be randomly assigned to Randomized Therapy 1 or Randomized Therapy 2 as illustrated above.
  3. Post-treatment follow-up period: Participants will be followed for at least 135 days post treatment. Follow-up may last up to five years.

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