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BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)

ConditionLimited Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSCRI Development Innovations, LLC

About this trial

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants.

The main goals of this study are to:

* Evaluate the efficacy of BMS-986489 vs durvalumab * Evaluate the safety profile of BMS-986489

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A)

Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1

Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy

Disqualifiers

Small-cell cancer not pulmonary in origin

Large cell neuroendocrine carcinoma

ES-SCLC

Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986489

    Drug

    BMS-986489 (fixed dose combination of atigotatug + nivolumab) will be administered as an intravenous infusion to be given once every 4 weeks for up to 2 years.

  • Durvalumab

    Drug

    Durvalumab will be administered as a fixed dose intravenous infusion to be given once every 4 weeks for up to 2 years.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: BMS-986489 (atigotatug + nivolumab)Experimental treatment 1 intervention
Group B: DurvalumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.

Time frame
From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and

Secondary outcomes

1

Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).

Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of an event, defined as the first documented radiological progression or death due to any cause.

Time frame
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
2

Evaluate the efficacy of BMS-986489 vs durvalumab Objective Response Rate (ORR).

Objective Response Rate (ORR) is defined as the proportion of participants with BOR of CR or PR according to RECIST v1.1.

Time frame
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
3

Evaluate the efficacy of BMS-986489 vs durvalumab by Clinical Benefit Rate (CBR).

Clinical Benefit Rate (CBR) is defined as the proportion of participants with BOR of CR or PR, or participants with SD lasting at least 180 days (i.e., ≥6 months) according to RECIST v1.1.

Time frame
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
4

Evaluate the efficacy of BMS-986489 vs durvalumab by Disease Control Rate (DCR).

Disease Control Rate (DCR) is defined as the proportion of participants with BOR of CR, PR, or SD according to RECIST v1.1

Time frame
Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SCRI Development Innovations, LLC

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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