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Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment

Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)

Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator

Participants must have ECOG Performance Status 0-1

Disqualifiers

Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression

Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis

Participants must not have clinically significant cardiac disease

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iza-bren

    Drug

    Specified dose on specified days

  • Osimertinib

    Drug

    Specified dose on days

  • Pemetrexed

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Cisplatin

    Drug

    Specified dose on specified days

Treatment groups

850 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Time frame
Up to approximately 3 years

Secondary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 5 years
2

PFS assessed by the investigator as per RECIST v1.1

Time frame
Up to approximately 3 years
3

Second Progression-Free Survival (PFS2) as assessed by the Investigator

Time frame
Up to approximately 5 years
4

Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

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

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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