Study on the Effectiveness and Safety of BAY 2927088 Compared to Standard Treatment in Advanced Non-Small Cell Lung Cancer with HER2 Mutations

Sponsor: Bayer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06452277

Provider View

This clinical trial is exploring a new treatment, BAY 2927088, for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. The study aims to see if this new treatment is safe and works better than the current standard treatments.

Patient Parameters

Program Overview

Researchers are testing a new treatment called BAY 2927088 for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes known as HER2 mutations. These mutations cause abnormal cell growth. The study aims to find out if BAY 2927088 can block the mutated HER2 protein and stop the cancer from spreading. Participants will receive either BAY 2927088 as a tablet twice a day or standard treatment through an IV every 21 days. The treatment will continue as long as it is beneficial and does not cause severe side effects. Doctors will monitor participants' health through scans, blood and urine tests, heart checks, and by asking about any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced non-squamous NSCLC that cannot be treated with surgery or has spread (Stage III-IV).
  • Have a specific HER2 mutation confirmed by a lab test.
  • Have not received prior treatment for advanced or metastatic NSCLC.
  • Eligible to receive certain chemotherapy and immunotherapy drugs as part of the study.

Exclusion Criteria

  • Have had another cancer in the past five years, unless it was treated and has not returned.
  • Have tumors with other targetable genetic changes that have approved treatments, except for HER2 mutations.
  • Cannot stop taking long-term steroid medications.
  • Have severe nerve damage.
  • Have had severe allergic reactions to certain antibody treatments.
  • Have had radiation therapy outside the brain within 21 days before starting the study.

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