IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

New Lung Cancer Drug Trial for Patients Progressing on Targeted Therapy

NCT: NCT07100080 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Bristol-Myers Squibb · Started: 2025-11-05 · Est. Completion: 2031-05-15

Plain English Summary

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) is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Non-Small Cell Lung Cancer. This trial tests a new drug called Izalontamab Brengitecan against standard chemotherapy for a specific type of lung cancer. It is for patients with non-small cell lung cancer (NSCLC) that has a specific gene mutation (EGFR) and has worsened after treatment with a targeted therapy. Participants will be randomly assigned to receive either the new drug or standard chemotherapy, and will have regular check-ups and scans. Standard chemotherapy (platinum-based doublet) is the current alternative treatment for this situation. The trial aims to enroll 596 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with non-squamous NSCLC that has not spread and is not curable by surgery or radiation. Must have a confirmed EGFR mutation (exon 19 deletion or L858R). Cancer must have progressed after treatment with a third-generation EGFR targeted therapy. Must be healthy enough to receive standard chemotherapy. This trial is studying Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how long patients live without their cancer getting worse, which is crucial for understanding how effective the new drug is. The specific primary outcome measures are: Recommended Phase 3 Dose (RP3D) of BMS-986507 (Approximately 3 months after the first dose); Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) (Up to 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for new treatments for lung cancer patients whose disease has progressed despite standard targeted therapies, offering a potential new option. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in a large patient population, with a potential new drug from a major pharmaceutical company, suggesting a potentially high market opportunity if successful Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 596 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your lung cancer has an EGFR mutation and if it has progressed on your current targeted therapy. Understand that you will be randomly assigned to receive either the new drug or chemotherapy, and you will not be able to choose which one. Participation involves regular clinic visits for drug administration, blood tests, and imaging scans to monitor your cancer. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* 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).

Exclusion criteria:

* 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 Locations

Frequently Asked Questions

What is clinical trial NCT07100080?

NCT07100080 is a Phase 3 INTERVENTIONAL study titled "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)." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 596 participants.

What conditions does NCT07100080 study?

This trial investigates treatments for Non-Small Cell Lung Cancer. The primary condition under study is Non-Small Cell Lung Cancer.

What treatments are being tested in NCT07100080?

The interventions being studied include: Iza-bren (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG). Specified dose on specified days

What does Phase 3 mean for NCT07100080?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT07100080?

This trial is currently "Recruiting." It started on 2025-11-05. The estimated completion date is 2031-05-15.

Who is sponsoring NCT07100080?

NCT07100080 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07100080?

The trial aims to enroll 596 participants. The trial is currently recruiting and accepting new participants.

How is NCT07100080 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07100080?

The primary outcome measures are: Recommended Phase 3 Dose (RP3D) of BMS-986507 (Approximately 3 months after the first dose); Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) (Up to 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07100080 being conducted?

This trial is being conducted at 20 sites, including Irvine, California; Orange, California; Edwards, Colorado; Gainesville, Florida and 16 more sites (United States).

Where can I find official information about NCT07100080?

The official record for NCT07100080 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07100080. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07100080 testing in simple terms?

This trial tests a new drug called Izalontamab Brengitecan against standard chemotherapy for a specific type of lung cancer. It is for patients with non-small cell lung cancer (NSCLC) that has a specific gene mutation (EGFR) and has worsened after treatment with a targeted therapy.

Why is this trial significant?

This trial addresses a critical need for new treatments for lung cancer patients whose disease has progressed despite standard targeted therapies, offering a potential new option. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT07100080?

The new drug may cause side effects, including those related to organ function and bone marrow. Potential side effects of chemotherapy include nausea, fatigue, and hair loss. The trial excludes patients with brain metastases or spinal cord compression, indicating these are serious conditions not suitable for this study. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07100080?

Ask your doctor if your lung cancer has an EGFR mutation and if it has progressed on your current targeted therapy. Understand that you will be randomly assigned to receive either the new drug or chemotherapy, and you will not be able to choose which one. Participation involves regular clinic visits for drug administration, blood tests, and imaging scans to monitor your cancer. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07100080 signal from an investment perspective?

This trial targets a significant unmet need in a large patient population, with a potential new drug from a major pharmaceutical company, suggesting a potentially high market opportunity if successful This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to receive either the new drug or standard chemotherapy, and will have regular check-ups and scans. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.