Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT07195695
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow.
In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation).
Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits.
Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zongertinib treatment arm Zongertinib - Standard of Care (SoC) treatment arm Pembrolizumab - Standard of Care (SoC) treatment arm Atezolizumab - Standard of Care (SoC) treatment arm Durvalumab - Standard of Care (SoC) treatment arm Nivolumab -
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) by investigator's assessment up to 8 years and 5 months DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
- Secondary Outcome Measures
Name Time Method Key secondary endpoint: Overall survival (OS), defined as the time from randomization until death from any cause up to 8 years and 5 months Occurrence of trial-related Adverse Events (AEs) ≥ Grade 3 from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start up to 3 years AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Trial Locations
- Locations (157)
Premier Cancer Care
🇺🇸Fresno, California, United States
University of California Los Angeles
🇺🇸Santa Monica, California, United States
Northern California Kaiser Permanente
🇺🇸Vallejo, California, United States
George Washington University Cancer Center
🇺🇸Washington D.C., District of Columbia, United States
Mid Florida Hematology and Oncology Center
🇺🇸Orange City, Florida, United States
Piedmont Cancer Institute
🇺🇸Atlanta, Georgia, United States
Northwest Georgia Oncology Centers
🇺🇸Marietta, Georgia, United States
Saint Alphonsus Regional Medical Center - Boise
🇺🇸Boise, Idaho, United States
University of Illinois Hospital and Health Sciences System
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Scroll for more (147 remaining)Premier Cancer Care🇺🇸Fresno, California, United StatesBoehringer IngelheimContact833-602-2368unitedstates@bitrialsupport.com