Beamion LUNG-2: Testing Zongertinib for Advanced Non-small Cell Lung Cancer with HER2 Mutations Compared to Standard Treatment

Sponsor: Boehringer Ingelheim

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06151574

Provider View

This study is for adults with advanced non-small cell lung cancer that has HER2 mutations. It aims to find out if a new drug, zongertinib, can slow down cancer better than the current standard treatment. Participants will be randomly assigned to receive either zongertinib or the standard chemotherapy and immunotherapy combination.

Patient Parameters

Program Overview

This clinical trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has HER2 mutations. The study is testing a new drug called zongertinib (BI 1810631) to see if it can slow down the progression of cancer more effectively than the current standard treatment, which includes pembrolizumab and platinum-pemetrexed chemotherapy. Participants will be randomly divided into two groups: one group will receive zongertinib, and the other will receive the standard treatment. The study will last up to 70 months, with regular visits every 3 weeks for health checks and tumor assessments using CT or MRI scans. The main goal is to compare how long it takes for the cancer to worsen in each group. Participants will also complete questionnaires about their symptoms and quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide written consent.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC).
  • Have a specific HER2 mutation in the cancer cells.
  • Must provide a tumor sample for confirmation of HER2 status.
  • Have not received any prior systemic treatment for advanced cancer.
  • Have at least one measurable tumor.
  • Be eligible to receive standard chemotherapy and immunotherapy treatment.

Exclusion Criteria

  • Have had another type of cancer in the last 5 years, except for certain treated skin cancers or other cancers considered cured.
  • Have tumors with other targetable mutations that have approved treatments.
  • Have severe lung-related illnesses.
  • Need to take medications that could interfere with the study.
  • Have had major surgery recently or plan to have it soon.
  • Have health conditions that could affect participation or the study's results.
  • Have serious heart problems or recent heart attacks, strokes, or blood clots.
  • Have significant heart rhythm issues.

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