Study on Zongertinib for Treating Surgically Removed Non-Small Cell Lung Cancer with HER2 Mutations
Sponsor: Boehringer Ingelheim
ClinicalTrials ID:NCT07195695
This clinical trial is testing whether a new medicine, zongertinib, can help people with early-stage non-small cell lung cancer (NSCLC) that has a specific HER2 gene mutation live longer without their cancer returning after surgery, compared to standard treatments.
Patient Parameters
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Program Overview
This study is for adults 18 and older who have early-stage non-small cell lung cancer (NSCLC) with a specific change in the HER2 gene. This change causes a faulty HER2 protein, which can lead to cancer growth. Participants must have had their lung cancer surgically removed and received certain other cancer treatments. The study aims to see if a new medicine, zongertinib, can help prevent the cancer from coming back after surgery, compared to standard treatments. Participants are randomly assigned to take either zongertinib daily for up to 3 years or receive a standard treatment, which could be an immunotherapy infusion or regular check-ups without active treatment. The study lasts up to 11 years, with regular check-ups and tests to monitor health and detect any cancer recurrence.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and able to give consent.
- Both men and women can participate. Women who can have children must use effective birth control.
- Must have a specific HER2 gene mutation in their cancer.
- Must have a confirmed diagnosis of primary non-small cell lung cancer (NSCLC).
- Must provide a tumor sample to confirm HER2 status.
- Cancer must be classified as Stage IIIB or lower before treatment.
- Must have a good performance status and adequate organ function based on lab tests.
Exclusion Criteria
- Cannot have NSCLC with mixed types or certain markers.
- Cannot have had major surgery within 4 weeks before starting the study.
- Cannot have had radiation therapy for primary NSCLC.
- Cannot have other mutations that have approved targeted treatments.
- Cannot have taken any investigational drugs recently.
- Cannot have certain lung diseases, active infections, or uncontrolled digestive issues.
- Cannot have had other cancers in the last 3 years, except for certain treated ones.
- Cannot have significant heart problems or certain heart test results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Premier Cancer Care | 93720 | Fresno | California |
| OPN Healthcare, Inc. | 91203 | Glendale | California |
| Sutter Health | 95661 | Roseville | California |
| University of California Los Angeles | 90404 | Santa Monica | California |
| Northern California Kaiser Permanente | 94589 | Vallejo | California |
| George Washington University Cancer Center | 20037 | Washington D.C. | District of Columbia |
| Mid Florida Hematology and Oncology Center | 32763 | Orange City | Florida |
| Piedmont Cancer Institute | 30318 | Atlanta | Georgia |
| Northwest Georgia Oncology Centers | 30060 | Marietta | Georgia |
| Saint Alphonsus Regional Medical Center - Boise | 83706 | Boise | Idaho |
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