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Monoclonal Antibodies

BAY2927088 for Non-Small Cell Lung Cancer (SOHO-02 Trial)

Phase 3

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.

Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).

Must not have

Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).

Prior radiotherapy outside of the brain within 21 days of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is looking for a new way to treat advanced non-small cell lung cancer (NSCLC) with specific genetic changes called HER2 mutations. They are testing a new treatment called BAY

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread and has specific HER2 gene mutations. Participants must be able to take oral medication and undergo regular health checks, imaging scans, and possibly pregnancy tests.

What is being tested?

The effectiveness and safety of BAY 2927088, a tablet taken twice daily aimed at blocking mutated HER2 proteins in NSCLC patients, are being compared with standard chemotherapy treatments administered via infusion every 21 days.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response to the treatment, typical chemotherapy-related issues such as nausea or hair loss, organ-specific inflammation, blood count changes, fatigue, and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old or the legal age of consent in my country.

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My lung cancer is advanced but not suitable for surgery or radiation.

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I can be treated with specific chemotherapy and pembrolizumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe nerve damage in my hands or feet.

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I had radiotherapy (not in the brain) over 3 weeks ago and have no side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS) per RECIST 1.1 as assessed by BICR

Secondary study objectives

Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity

Change from baseline in EORTC QLQ-C30 global health status/QoL

Change from baseline in EORTC QLQ-C30 physical functioning domain score

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BAY2927088Experimental Treatment1 Intervention

Participants will receive BAY2927088 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.

Group II: Standard of care (SoC)Active Control4 Interventions

Participants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BAY2927088

2024

Completed Phase 1

~90

0 / 5Eligibility criteria met