Zongertinib Clinical Trials (2026): 16 Studies for Healthy & Lung Cancer, Non-squamous, Non-small Cell
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
16 Zongertinib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 8 indications (including Healthy & Lung Cancer, Non-squamous, Non-small Cell) and 2,931 total planned enrollment. 2 Phase 3 Zongertinib trials and 3 Phase 2 are listed. 6 Zongertinib clinical trials are actively recruiting at 35 U.S. sites across 17 states. Most recent activity: NCT07195695 (Sep 2036).
Where to Participate: All Zongertinib Trial Sites in the U.S. (35 sites across 17 states)
Every actively recruiting Zongertinibtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AK | Alaska Oncology and Hematology, LLC | Anchorage99508 | NCT06581432 | Map |
| CA | Precision NextGen Oncology | Beverly Hills90212 | NCT06581432 | Map |
| CA | The Oncology Institute of Hope and Innovation | Cerritos90703 | NCT06324357 | Map |
| CA | ClinRé 001-022 (Premier Cancer Care and Infusion Center) | Fresno93710 | NCT07195695 | Map |
| CA | OPN Healthcare, Inc. | Glendale91203 | NCT07195695 | Map |
| CA | Valkyrie Clinical Trials | Los Angeles90067 | NCT06581432 | Map |
| CA | Valkyrie Clinical Trials | Los Angeles90067 | NCT06324357 | Map |
| CA | University of California Irvine | Orange92868 | NCT06324357 | Map |
| CA | University of California San Francisco | San Francisco94143 | NCT07195695 | Map |
| CA | University of California Los Angeles | Santa Monica90404 | NCT07195695 | Map |
| CT | Yale University School of Medicine | New Haven06511 | NCT06581432 | Map |
| CT | Yale University School of Medicine | New Haven06510 | NCT06324357 | Map |
| FL | Helios CR Inc | Lakeland33812 | NCT06324357 | Map |
| FL | Mid Florida Hematology and Oncology Center | Orange City32763 | NCT07195695 | Map |
| FL | BRCR Global | Tamarac33321 | NCT06581432 | Map |
| GA | Piedmont Cancer Institute | Atlanta30318 | NCT07195695 | Map |
| GA | Northwest Georgia Oncology Centers | Marietta30060 | NCT07195695 | Map |
| IL | University of Illinois Hospital and Health Sciences System | Chicago60612 | NCT07195695 | Map |
| IN | Community MD Anderson Cancer Center - East Medical Oncology | Indianapolis46219 | NCT06581432 | Map |
| IA | University of Iowa Hospitals and Clinics | Iowa City52242 | NCT06324357 | Map |
| MA | Dana-Farber Cancer Institute | Boston02215 | NCT07195695 | Map |
| NV | Cancer Care Specialists | Reno89511 | NCT07195695 | Map |
| NY | Icahn School of Medicine at Mount Sinai | New York10029 | NCT06581432 | Map |
| NY | Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York10016 | NCT07195695 | Map |
| NY | Memorial Sloan-Kettering Cancer Center | New York10065 | NCT06581432 | Map |
| NY | Memorial Sloan-Kettering Cancer Center | New York10065 | NCT07195695 | Map |
| OR | Providence Cancer Institute | Portland97213 | NCT07195695 | Map |
| TN | SCRI Oncology Partners | Nashville37203 | NCT06324357 | Map |
| TN | Tennessee Oncology, Pllc | Nashville37203 | NCT06324357 | Map |
| TX | Hendrick Health | Abilene79601 | NCT07195695 | Map |
| TX | The University of Texas MD Anderson Cancer Center | Houston77030 | NCT06581432 | Map |
| UT | Community Cancer Trials of Utah | Ogden84405 | NCT07195695 | Map |
| VA | Virginia Cancer Specialists, PC | Fairfax22031 | NCT06581432 | Map |
| VA | Virginia Cancer Specialists, PC | Fairfax22031 | NCT06324357 | Map |
| WA | Fred Hutchinson Cancer Research Center | Seattle98109 | NCT06324357 | Map |
Zongertinib clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | not yet recruiting | Total |
|---|---|---|---|---|---|
| P1 | 1 | 1 | 8 | 10 | |
| P1/P2 | 1 | 1 | |||
| P2 | 2 | 1 | 3 | ||
| P3 | 1 | 1 | 2 |
Recruiting Zongertinib clinical trials (6)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07195695 | Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations | P3 | Non-small Cell Lung Cancer | 400 | Jan 2026 |
| NCT07486817 | Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab | P2 | Lung Cancer, Non-squamous, Non-small Cell | 60 | Jun 2026 |
| NCT06324357 | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread | P1/P2 | Metastatic Breast Cancer | 768 | Jun 2024 |
| NCT06581432 | Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations | P2 | Solid Tumours | 430 | Oct 2024 |
| NCT07619066 | AGATHAA Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. | P2 | Advanced Breast Cancer | 25 | Oct 2026 |
| NCT07649941 | A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood | P1 | Healthy | 16 | Jun 2026 |
Zongertinib clinical trials by indication
Healthy (8)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07649941 | — | P1 | recruiting | A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood |
| NCT06504862 | — | P1 | completed | A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood |
| NCT06494761 | — | P1 | completed | A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body |
| NCT06360081 | — | P1 | completed | A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers |
| NCT06075277 | — | P1 | completed | A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food |
| NCT06028464 | — | P1 | completed | A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood |
| NCT05879991 | BI 1810631 | P1 | completed | A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body |
| NCT05833139 | BI 1810631 | P1 | completed | A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood |
Lung Cancer, Non-squamous, Non-small Cell (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07486817 | — | P2 | recruiting | Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab |
| NCT06151574 | BI 1810631 | P3 | active not recruiting | Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment |
Advanced Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07619066 | AGATHA | P2 | not yet recruiting | A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. |
Non-small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07195695 | — | P3 | recruiting | Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations |
Liver Diseases (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06692322 | — | P1 | completed | A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems |
Solid Tumours (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06581432 | — | P2 | recruiting | Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations |
Metastatic Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06324357 | — | P1/P2 | recruiting | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread |
Neoplasm Metastasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04886804 | — | P1 | active not recruiting | Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) |
Zongertinib pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| BI 1810631 | NCT06151574 | P3 | active not recruiting | Lung Cancer, Non-squamous, Non-small Cell | 428 | — |
| AGATHA | NCT07619066 | P2 | not yet recruiting | Advanced Breast Cancer | 25 | — |
All Zongertinib trials (16)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07195695 | Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations | P3 | recruiting | 400 | Boehringer Ingelheim | Jan 2026 | |
| NCT07486817 | Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab | P2 | recruiting | 60 | Boehringer Ingelheim | Jun 2026 | |
| NCT06324357 | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread | P1/P2 | recruiting | 768 | Boehringer Ingelheim | Jun 2024 | |
| NCT06581432 | Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations | P2 | recruiting | 430 | Boehringer Ingelheim | Oct 2024 | |
| NCT07619066 | AGATHA | A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. | P2 | not yet recruiting | 25 | MedSIR | Oct 2026 |
| NCT04886804 | Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) | P1 | active not recruiting | 608 | Boehringer Ingelheim | Jul 2021 | |
| NCT06151574 | BI 1810631 | Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment | P3 | active not recruiting | 428 | Boehringer Ingelheim | Feb 2024 |
| NCT07649941 | A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood | P1 | recruiting | 16 | Boehringer Ingelheim | Jun 2026 | |
| NCT06692322 | A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems | P1 | completed | 29 | Boehringer Ingelheim | Jan 2025 | |
| NCT06504862 | A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood | P1 | completed | 32 | Boehringer Ingelheim | Aug 2024 | |
| NCT06494761 | A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body | P1 | completed | 16 | Boehringer Ingelheim | Jul 2024 | |
| NCT06360081 | A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers | P1 | completed | 56 | Boehringer Ingelheim | Apr 2024 | |
| NCT06075277 | A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food | P1 | completed | 16 | Boehringer Ingelheim | Oct 2023 | |
| NCT06028464 | A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood | P1 | completed | 16 | Boehringer Ingelheim | Sep 2023 | |
| NCT05879991 | BI 1810631 | A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body | P1 | completed | 15 | Boehringer Ingelheim | Aug 2023 |
| NCT05833139 | BI 1810631 | A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood | P1 | completed | 16 | Boehringer Ingelheim | Apr 2023 |
Zongertinib clinical trials: frequently asked questions
- How many Zongertinib clinical trials are there?
- 16 Zongertinib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 5 are actively recruiting participants. 8 are marked completed.
- Are Zongertinib clinical trials recruiting in 2026?
- Yes — 5 Zongertinib trials are actively recruiting in 2026, with 35 U.S. sites across 17 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Zongertinib being studied for?
- Zongertinib is being studied for Healthy, Lung Cancer, Non-squamous, Non-small Cell, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, HER2 Mutation and 10 more. The trials are grouped by indication on this page.
- What phase is Zongertinib in?
- Zongertinib clinical trials span 2 Phase 3, 3 Phase 2, 10 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Zongertinib clinical trials?
- The lead sponsor across the most Zongertinib trials is Boehringer Ingelheim, with 1 additional lead sponsor listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Zongertinibas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: