zongertinib: zongertinib
pembrolizumab: pembrolizumab
cisplatin: platinum-pemetrexed chemotherapy
carboplatin: platinum-pemetrexed chemotherapy
pemetrexed: platinum-pemetrexed chemotherapy
This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy.
Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein.
Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.
| Facility | City | Region | Status |
|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | |
| Pioneer Research Center - Bullhead City | Bullhead City | Arizona | |
| Precision NextGen Oncology | Beverly Hills | California | |
| ClinRé 001-022 (Premier Cancer Care and Infusion Center) | Fresno | California | |
| OPN Healthcare, Inc. | Glendale | California | |
| Scripps Green Hospital | La Jolla | California | |
| Valkyrie Clinical Trials | Los Angeles | California | |
| Sharp Memorial Hospital | San Diego | California | |
| St. Louis Cancer Care, LLP | Bridgeton | Missouri | |
| Oncology Hematology Associates | Springfield | Missouri | |
| Cancer Care Specialists | Reno | Nevada | |
| Northwell Health | Lake Success | New York | |
| Montefiore Medical Center | The Bronx | New York | |
| Regional Medical Oncology Center | Wilson | North Carolina | |
| Gabrail Cancer Center | Canton | Ohio | |
| Carolina Blood and Cancer Care Associates, PA | Rock Hill | South Carolina | |
| SCRI Oncology Partners | Nashville | Tennessee | |
| Huntsman Cancer Institute | Salt Lake City | Utah | |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | |
| Swedish Cancer Institute | Edmonds | Washington | |
| Swedish Cancer Institute | Issaquah | Washington | |
| Swedish Cancer Institute | Seattle | Washington | |
| Clinica Adventista Belgrano | CABA | Argentina | |
| Instituto Medico Especializado Alexander Fleming | Ciudad Autónoma de Bs As | Argentina | |
| Instituto Oncologico de Cordoba | Córdoba | Argentina | |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | Argentina | |
| Instituto Médico de la Fundación Estudios Clínicos | Rosario | Argentina | |
| Prince of Wales Hospital-Randwick-66496 | Randwick | New South Wales | |
| Royal North Shore Hospital-St Leonards-20807 | St Leonards | New South Wales | |
| Princess Alexandra Hospital | Woolloongabba | Queensland | |
| Austin Health | Heidelberg | Victoria | |
| St John of God Subiaco Hospital | Subiaco | Western Australia | |
| Krems University Hospital | Krems | Austria | |
| Clinic Floridsdorf | Vienna | Austria | |
| Brussels - HOSP Jules Bordet | Anderlecht | Belgium | |
| Universitair Ziekenhuis Gent | Ghent | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Associacao Dr. Bartholomeu Tacchini | Bento Gonçalves | Brazil | |
| Hospital do Câncer de Londrina | Londrina | Brazil | |
| Hospital Sao Lucas da PUCRS | Porto Alegre | Brazil |
+ 123 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06151574 on ClinicalTrials.gov ↗ ← All trials in the UK