Health Trials

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-squamous NSCLC, not amenable to treatment in curative intent.

Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).

Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.

Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).

Disqualifiers

Inadequate organ function and/or bone marrow reserve.

Leptomeningeal metastases or spinal cord compression.

Poorly controlled systemic medical conditions.

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

  • Carboplatin

    Drug

    Specified dose on specified days

  • Cisplatin

    Drug

    Specified dose on specified days

  • Pemetrexed

    Drug

    Specified dose on specified days

Treatment groups

500 Participants
are divided into 5 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CActive comparator 3 interventions
Group D: Arm DExperimental treatment 1 intervention
Group E: Arm EActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Recommended Phase 3 Dose (RP3D) of BMS-986507

Phase 2

Time frame
Approximately 3 months after the first dose
2

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

Phase 3

Time frame
Up to 3 years

Secondary outcomes

1

Objective Response (OR) Assessed by RECIST v1.1 per BICR

Phase 2

Time frame
Up to 3 years
2

PFS Assessed by RECIST v1.1 per BICR

Phase 2

Time frame
Up to 3 years
3

Overall Survival (OS)

Phase 3

Time frame
Up to 5 years
4

PFS Assessed by RECIST v1.1 per investigator assessment

Phase 3

Time frame
Up to 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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