What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve targeted therapies that inhibit specific proteins like EGFR (Epidermal Growth Factor Receptor) and HER2 (Human Epidermal Growth Factor Receptor 2). EGFR inhibitors, such as osimertinib and erlotinib, block the signaling pathways that promote cancer cell growth and division, particularly in patients with EGFR mutations. Similarly, HER2 inhibitors, like trastuzumab, target HER2 proteins that are overexpressed in some NSCLC tumors, thereby inhibiting tumor growth and spread. These targeted therapies are crucial for NSCLC patients as they offer a more personalized treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that target EGFR and HER2, such as erlotinib and trastuzumab, have several known side effects. Erlotinib is associated with fatigue, rash, diarrhea, and anorexia, with severe cases including pneumonitis. Trastuzumab, often used in combination with chemotherapy, can cause decreased neutrophil count, anemia, nausea, and interstitial lung disease. Other general side effects of NSCLC treatments include tumor-related bleeding, particularly in patients with squamous cell histology or centrally located tumors, and various toxicities like fatigue, nausea, and diarrhea.

What prior FDA approvals exist?

Several drugs targeting EGFR and HER2 mutations in NSCLC have received FDA approval. Erlotinib, an EGFR tyrosine kinase inhibitor, has shown benefits in progression-free survival and overall survival in patients with activating EGFR mutations. For HER2 mutations, fam-trastuzumab deruxtecan is approved for patients with unresectable or metastatic NSCLC who have received prior systemic therapy, demonstrating a median progression-free survival of 8.2 months and an overall survival of 17.8 months. Additionally, ado-trastuzumab emtansine has shown efficacy in HER2-mutant advanced lung cancer with a response rate of 44% and a median progression-free survival of five months.

What other types of research exist?

Promising alternatives to BAY2927088 for NSCLC patients include HM781-36B, a potent pan-HER inhibitor effective against EGFR, HER2, and HER4, including the T790M resistance mutation. Another option is YH25448, a third-generation EGFR inhibitor with potent systemic and intracranial activity, particularly for T790M mutated NSCLC.

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Tyrosine Kinase Inhibitor

BAY2927088 for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

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

Must have

Adequate liver function as assessed by specific laboratory tests

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Must not have

History of primary brain or leptomeningeal disease, symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local treatment

Known human immunodeficiency virus (HIV) or active Hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up about 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BAY2927088 for people with advanced lung cancer. The drug aims to block certain proteins that help cancer grow. Researchers want to find out how safe the drug is, the best dose to use, and how well it works in stopping cancer.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) who have specific mutations in EGFR or HER2 genes. Participants must have a life expectancy of at least 12 weeks, measurable disease by scans, and adequate organ function. They should have progressed after prior therapy but can't join if they've had certain recent treatments, unresolved toxicities from past cancer treatment, HIV/Hepatitis B/C infection, brain metastases requiring treatment, or serious heart issues.

What is being tested?

The study tests different formulations of BAY2927088 to find the safest dose that affects the body positively and determine how it's processed by the body. It involves three parts: increasing doses until safe limits are found (Dose Escalation), confirming these findings (Backfill), and giving an appropriate dose based on earlier results (Dose Expansion). Patients take the drug daily in cycles lasting three weeks each.

What are the potential side effects?

As this is a first-in-human study for BAY2927088, all potential side effects aren't known yet. However, participants will be closely monitored for any adverse events such as changes in blood work results or physical symptoms that could indicate organ inflammation or other reactions to the new medication.

Eligibility Criteria

Inclusion Criteria

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

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My liver is working well, according to recent tests.

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I am fully active or can carry out light work.

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My blood tests show my bone marrow is working well.

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My cancer has a confirmed EGFR or HER2 mutation from a certified lab.

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My kidney function is within normal limits according to recent tests.

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My lung cancer is advanced but not treatable with surgery or radiation.

Exclusion Criteria

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

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I have not had brain cancer or cancer spread to my brain that needed treatment.

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I do not have HIV or active Hepatitis B or C.

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I have a serious heart condition that needs treatment.

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I haven't taken EGFR inhibitors recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~about 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and about 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

AUC(0-12) of BAY2927088 for BID

AUC(0-12)md of BAY2927088 for BID

AUC(0-24) of BAY2927088 for QD

+4 more

Secondary study objectives

Overall response rate (ORR) as per RECIST v1.1 by investigator assessment

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Extension partExperimental Treatment2 Interventions

Initiation of the Extension part will depend on the benefit-risk profile observed during Dose Expansion. Additionally, enrollment may be prematurely terminated based on emerging data at the discretion of the Sponsor.

Group II: Dose expansionExperimental Treatment2 Interventions

Eight independent groups (group A, B1, B2, C, D, E, F, G) are planned. Dose Expansion may start at a dose level that has been evaluated in Escalation/Backfill in at least 9 participants and considered safe or at any other dose levels that are below the highest dose level that is considered safe.

Group III: Dose escalationExperimental Treatment3 Interventions

Doses of BAY2927088 will be increased in a stepwise fashion up to the MTD or MAD.

Group IV: BackfillExperimental Treatment3 Interventions

Dose Escalation and Backfill run concurrently

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve targeted therapies that inhibit specific proteins like EGFR (Epidermal Growth Factor Receptor) and HER2 (Human Epidermal Growth Factor Receptor 2). EGFR inhibitors, such as osimertinib and erlotinib, block the signaling pathways that promote cancer cell growth and division, particularly in patients with EGFR mutations. Similarly, HER2 inhibitors, like trastuzumab, target HER2 proteins that are overexpressed in some NSCLC tumors, thereby inhibiting tumor growth and spread. These targeted therapies are crucial for NSCLC patients as they offer a more personalized treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.