Neoplasm MetastasisPhase 1NCT04886804
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)
A Phase 1 study testing zongertinib in people with Neoplasm Metastasis and Non-Small Cell Lung Cancer, run by Boehringer Ingelheim at 85 sites in 18 countries.
Trial summary
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Non-Small Cell Lung Cancer
- What is being tested?
- zongertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 85 sitesin 18 countries
- Study dates
- 2 Jul 2021to 30 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6, 7 and 9) .
- Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment.
- Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).
- Adequate organ function defined as all of the following:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (≥ 1.5 x 10^3/μL) (≥ 1500/mm^3); haemoglobin ≥ 9.0 g/dL (≥ 90 g/L) (≥ 5.6 mmol/L); platelets ≥ 100 x 10^9/L (100 x 10^3/μL) (100 x 10^3/mm3) without the use of hematopoietic growth factors within 4 weeks of start of trial medication.
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- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
- Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min - calculated using Chronic Kidney Disease Epidemiology (CKD-EPI) formula (≥ 30 mL/min/1.73m² for cohorts 6, 8, and 9).
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
- Alkaline Phosphatase < 5 x ULN.
- Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2)
- Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.
- At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
- Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Male or female patients. Women of childbearing potential (WOCBP) and men who are able to father a child must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Additional inclusion criteria for Phase Ia
- Patients with a documented diagnosis of HER2 aberration: overexpression OR gene amplification OR non-synonymous somatic mutation OR gene rearrangement involving HER2 or Neuregulin 1 (NRG1)
- Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted, or not be a suitable candidate for, available treatment options known to prolong survival for their disease
- Additional inclusion criteria for Phase Ib - Cohort 1 only
- Non-squamous non-small cell lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results.
- Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with non-squamous NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.
- Additional inclusion criteria for Phase Ib - Cohort 2 only
- Non-squamous NSCLC patient with a documented HER2 mutation in the tyrosine kinase domain (TKD) as per local lab results.
- Treatment naïve for non-squamous NSCLC.
- Additional inclusion criteria for Phase Ib - Cohort 3 only
- NSCLC Patient with a documented HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results or squamous NSCLC patient with mutation in the TKD as per local lab results. After implementation of CTP v8, only non-squamous NSCLC patients with a documented activating HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results.
- Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy. After implementation of CTP v8, patients who had received, in the advanced/metastatic setting, at least one line of systemic therapy OR patients who are treatment naïve for non-squamous NSCLC (no prior systemic therapy, immunotherapy or targeted therapy for stage IIIB or IV adenocarcinoma).
- Additional inclusion criteria for Phase Ib - Cohort 4 only
- NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
- NSCLC patients who are either treatment naïve or who had received any prior line of treatment, in the advanced/metastatic setting. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.
- Patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
- Additional inclusion criteria for Phase Ib - Cohort 5 only
- Non-squamous NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
- Patient should have received, in the advanced/metastatic setting, at least one line of systemic therapy that includes a platinum-based combination chemotherapy and should have been treated with previous HER2 directed antibody-drug conjugates (ADC) in the same advanced/metastatic setting and developed disease progression recurrence during or after completing this therapy. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.
- Additional inclusion criteria for Phase Ib - Cohort 6 only
- Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
- Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
- Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
- Patient who is not eligible for any other recruiting cohort.
- Additional inclusion criteria for Phase Ib - Cohort 7 only
- Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
- Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
- Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
- Patient who is not eligible for any other recruiting cohort.
- Additional inclusion criteria for Phase Ib - Cohort 8 only
- Treatment naïve for NSCLC
- NSCLC (adenocarcinoma or squamous) patient with documented HER2 mutation in the tyrosine kinase domain (TKD) or non-squamous NSCLC with a documented HER2 mutation in the non tyrosine kinase domain (non TKD) as per local lab results
- Additional inclusion criteria for Phase Ib - Cohort 9 only
- Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
- Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.
- Further inclusion criteria apply.
Who cannot join
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening
- Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local treatment.
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- Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication
- Patients who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial
- Previous treatment with zongertinib.
- Radiotherapy within 2 weeks prior to first study treatment, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week prior to first study treatment.
- Further exclusion criteria apply.
Trial locations and contacts
85 sites in 18 countries.
85 sites in 18 countries
United States20 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
Precision NextGen Oncology
Beverly Hills, California, 90212
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cleveland Clinic
Cleveland, Ohio, 44195
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
City of Hope-Duarte-56419
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Holy Cross Hospital-Fort Lauderdale-57892
Fort Lauderdale, Florida, 33308
Hawaii Cancer Care - Honolulu
Honolulu, Hawaii, 96813
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
City of Hope - Seacliff
Huntington Beach, California, 92648
City of Hope-Irvine-69674
Irvine, California, 92618
Valkyrie Clinical Trials
Los Angeles, California, 90067
Sarah Cannon Research Institute-Nashville-48456
Nashville, Tennessee, 37203
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
University of California Irvine
Orange, California, 92868
University of California Davis
Sacramento, California, 95817
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Georgetown University
Washington D.C., District of Columbia, 20007
China15 sites
Beijing Cancer Hospital
Beijing, 100036
Jilin Province Cancer Hospital
Changchun, 130012
The First Hospital of Jilin University
Changchun, 130021
Fujian Cancer Hospital
Fuzhou, 350014
Guangdong Provincial People's Hospital
Guangzhou, 510080
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
Zhejiang Cancer Hospital
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning, 530021
Shanghai Chest Hospital
Shanghai, 200030
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
First Affiliated Hospital of Xiamen University
Xiamen, 361003
Henan Cancer Hospital
Zhengzhou, 450008
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
Japan7 sites
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Shikoku Cancer Center
Ehime, Matsuyama, 791-0280
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Kindai University Hospital
Osaka, Sakai, 590-0197
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
France6 sites
Hopital Louis Pradel
Bron, 69677
CTR Leon Berard
Lyon, 69373
HOP Timone
Marseille, 13385
INS Curie
Paris, 75005
HOP Pontchaillou
Rennes, 35000
Institut Gustave Roussy
Villejuif, 94805
Spain6 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08907
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Clinico Universitario de Valencia
Valencia, 46010
Germany5 sites
Universitätsklinikum Augsburg
Augsburg, 86156
Universitätsklinikum Köln (AöR)
Cologne, 50937
Technische Universität Dresden
Dresden, 01307
Justus-Liebig Universität Gießen
Giessen, 35392
Pius-Hospital, Oldenburg
Oldenburg, 26121
South Korea5 sites
Chungbuk National University Hospital
Chungju, 28644
Seoul National University Bundang Hospital
Seongnam, 13620
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Israel4 sites
Rambam Medical Center
Haifa, 3109601
Meir Medical Center
Kfar Saba, 44281
Sourasky Medical Center
Tel Aviv, 6423906
The Chaim Sheba Medical Center Tel HaShomer
Tel HaShomer, 52621
Italy3 sites
Istituto Di Candiolo
Candiolo (TO), 10060
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131
Azienda Ospedaliera Unversitaria di Parma
Parma, 43100
United Kingdom3 sites
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
Hammersmith Hospital
London, W12 0HS
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
Hong Kong2 sites
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, 999077
Queen Mary Hospital
Hong Kong
Netherlands2 sites
Nederlands Kanker Instituut
Amsterdam, 1066 CX
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA
Singapore2 sites
National University Hospital-Singapore-22806
Singapore, 119228
National Cancer Centre Singapore
Singapore, 169610
About this study
Official title: Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.
The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.
Read more
The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.
In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.
The participants are in the study for as long as they benefit from and can tolerate treatment.
Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
- Conditions
- Neoplasm Metastasis, Non-Small Cell Lung Cancer
- Being tested
- zongertinib
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zongertinibDrug
Also called BI 1810631, Hernexeos®
zongertinib
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia - Dose escalation part | Experimental | Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy. Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 1 | Experimental | Not described Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 2 | Experimental | Not described Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 3 | Experimental | Not described Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 4 | Experimental | Not described Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 5 | Experimental | Not described Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 6 | Experimental | Cohort only in the United States of America (USA) Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 7 | Experimental | Cohort only in Japan Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 8 | Experimental | Cohort only in the United States of America (USA) Receives: Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 9 | Experimental | Cohort only in China Receives: Drug: zongertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Maximum Tolerated Dose (MTD)
Maximum tolerated dose is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period in any studied regimen.
Measured: At the end of Cycle 1 (each cycle is 21 days).
Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Measured: At the end of Cycle 1 (each cycle is 21 days).
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response (OR) as assessed by central independent review
OR is defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, from the first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (patients prior to CTP v8.0), 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment
Clincal Trial Protocol version 8.0 = CTP v8.0
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib: Cohort 4: Objective response according to Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Secondary outcomes (30)
Phase Ia: Number of patients experiencing DLTs during the entire treatment period
Measured: From the start of the trial treatment until end of month 8, up to 8 months.
Phase Ia: Maximum measured concentration of zongertinib in plasma (Cmax)
Measured: On day 1 and on day 15 of Cycle 1 (each cycle is 21 days).
Phase Ia: Area under the concentration-time curve of zongertinib in plasma (AUC0-t2)
Measured: On day 1 and on day 15 of Cycle 1 (each cycle is 21 days).
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Duration of objective response (DoR) according to RECIST 1.1
DoR is defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response as assessed by central independent review.
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control (DC)
DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST version 1.1 as assessed central independent review, from first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Progression-free survival (PFS)
PFS is defined as the time from first treatment administration until tumor progression according to RECIST version 1.1 as assessed by central independent review, or death from any cause, whichever occurs earlier.
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response according to response assessment in RANO-BM criteria as assessed by central independent review for patients with central nervous system (CNS) lesions at baseline
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control according to RANO-BM criteria as assessed by central independent review for patients with CNS lesions at baseline
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Duration of objective response according to RECIST 1.1 by investigator assessment
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RECIST 1.1 as assessed by the investigator
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Progression-free survival according to RECIST 1.1 as assessed by the investigator
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Objective response according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Duration of objective response (DoR) according to RANO-BM by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Disease control (DC) according to RANO-BM by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Progression-free survival (PFS) according to RANO-BM as assessed by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DoR in CNS lesions according to RECIST 1.1 by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DC in CNS lesions according to RECIST 1.1 by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: PFS in CNS lesions according to RECIST 1.1 as assessed by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: OR according to RECIST 1.1 by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Duration of OR according to RECIST 1.1 by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DC according to RECIST 1.1 by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: PFS according to RECIST 1.1 by central independent review
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - All cohorts: Overall survival (OS), defined as time from first treatment administration until death from any cause
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - All Cohorts: Number of patients experiencing DLTs during the entire treatment period
Measured: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - All Cohorts: Change from baseline to Day 1 of Cycle 5 in EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) physical functioning domain score
Measured: Baseline and on Day 1 of Cycle 5 (each cycle is 21 days).
Phase Ib - All Cohorts: Change from baseline to Day 1 of Cycle 5 in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score
Measured: Baseline and on Day 1 of Cycle 5 (each cycle is 21 days).
Phase Ib - All Cohorts: Change from baseline to Day 1 of Cycle 5 in EORTC item List 46 (IL46) score
Measured: Baseline and on Day 1 of Cycle 5 (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start2 Jul 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886804
- Sponsor's protocol ID
- 1479-0001
- Other IDs
- 2020-004563-47, 2024-511246-39-00, U1111-1312-5969
- Status last verified
- Sep 2026
- First submitted
- 4 May 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Publications
Heymach JV, Yamamoto N, Girard N, Ruiter G, Smit EF, Planchard D, Nadal E, Wu YL, Zugazagoitia J, Tu HY, Baik CS, Yoh K, Soo RA, Zhao Y, Sabari JK, Wermke M, Scheffler M, Ahn MJ, Fernamberg K, Schroeter L, Sadrolhefazi B, Thamer C, Eigenbrod-Giese S, Popat S; Beamion LUNG-1 Investigators. First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2026 Apr 30;394(17):1675-1684. doi: 10.1056/NEJMoa2516969. Epub 2026 Apr 15.
PubMed 41985129Heymach JV, Ruiter G, Ahn MJ, Girard N, Smit EF, Planchard D, Wu YL, Cho BC, Yamamoto N, Sabari JK, Zhao Y, Tu HY, Yoh K, Nadal E, Sadrolhefazi B, Rohrbacher M, von Wangenheim U, Eigenbrod-Giese S, Zugazagoitia J; Beamion LUNG-1 Investigators. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Jun 19;392(23):2321-2333. doi: 10.1056/NEJMoa2503704. Epub 2025 Apr 28.
PubMed 40293180Heymach JV, Opdam F, Barve M, Tu HY, Wu YL, Berz D, Schroter L, Botilde Y, Sadrolhefazi B, Serra J, Yoh K, Yamamoto N. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study. J Clin Oncol. 2025 Apr 10;43(11):1337-1347. doi: 10.1200/JCO-24-01727. Epub 2025 Mar 3.
PubMed 40030100Heymach J, Opdam F, Barve M, Gibson N, Sadrolhefazi B, Serra J, Yamamoto N. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. Clin Lung Cancer. 2023 Mar;24(2):e65-e68. doi: 10.1016/j.cllc.2022.10.008. Epub 2022 Nov 11.
PubMed 36528522
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations
- ClinicalTrials.gov ID
- NCT04886804
- Acronym / sponsor ID
- 1479-0001
- Conditions
- Neoplasm Metastasis, Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.
The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.
The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.
In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.
The participants are in the study for as long as they benefit from and can tolerate treatment.
Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase Ia - Dose escalation part | Experimental | Drug: zongertinibConsecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy. |
| Phase Ib - Dose expansion part: Cohort 1 | Experimental | Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 2 | Experimental | Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 3 | Experimental | Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 4 | Experimental | Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 5 | Experimental | Drug: zongertinib |
| Phase Ib - Dose expansion part: Cohort 6 | Experimental | Drug: zongertinibCohort only in the United States of America (USA) |
| Phase Ib - Dose expansion part: Cohort 7 | Experimental | Drug: zongertinibCohort only in Japan |
| Phase Ib - Dose expansion part: Cohort 8 | Experimental | Drug: zongertinibCohort only in the United States of America (USA) |
| Phase Ib - Dose expansion part: Cohort 9 | Experimental | Drug: zongertinibCohort only in China |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (51 listed)
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6, 7 and 9) .
- Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment.
- Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).
- Adequate organ function defined as all of the following:
Key exclusion criteria (11 listed)
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening
- Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except:
- Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication
- Patients who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial
- Previous treatment with zongertinib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zongertinibAlso: BI 1810631, Hernexeos®zongertinib | Drug | Phase Ia - Dose escalation part, Phase Ib - Dose expansion part: Cohort 1, Phase Ib - Dose expansion part: Cohort 2, Phase Ib - Dose expansion part: Cohort 3, Phase Ib - Dose expansion part: Cohort 4, Phase Ib - Dose expansion part: Cohort 5, Phase Ib - Dose expansion part: Cohort 6, Phase Ib - Dose expansion part: Cohort 7, Phase Ib - Dose expansion part: Cohort 8, Phase Ib - Dose expansion part: Cohort 9 |
Primary outcome
Phase Ia: Maximum Tolerated Dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 21 days).
Maximum tolerated dose is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period in any studied regimen.
Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Time frame: At the end of Cycle 1 (each cycle is 21 days).
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response (OR) as assessed by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
OR is defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, from the first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.
Phase Ib - Cohorts 3 (patients prior to CTP v8.0), 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Clincal Trial Protocol version 8.0 = CTP v8.0
Phase Ib: Cohort 4: Objective response according to Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
30 secondary outcomes
Phase Ia: Number of patients experiencing DLTs during the entire treatment period
Time frame: From the start of the trial treatment until end of month 8, up to 8 months.
Phase Ia: Maximum measured concentration of zongertinib in plasma (Cmax)
Time frame: On day 1 and on day 15 of Cycle 1 (each cycle is 21 days).
Phase Ia: Area under the concentration-time curve of zongertinib in plasma (AUC0-t2)
Time frame: On day 1 and on day 15 of Cycle 1 (each cycle is 21 days).
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Duration of objective response (DoR) according to RECIST 1.1
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control (DC)
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Progression-free survival (PFS)
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response according to response assessment in RANO-BM criteria as assessed by central independent review for patients with central nervous system (CNS) lesions at baseline
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control according to RANO-BM criteria as assessed by central independent review for patients with CNS lesions at baseline
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Duration of objective response according to RECIST 1.1 by investigator assessment
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RECIST 1.1 as assessed by the investigator
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Progression-free survival according to RECIST 1.1 as assessed by the investigator
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Objective response according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Duration of objective response (DoR) according to RANO-BM by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Disease control (DC) according to RANO-BM by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Progression-free survival (PFS) according to RANO-BM as assessed by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DoR in CNS lesions according to RECIST 1.1 by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DC in CNS lesions according to RECIST 1.1 by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: PFS in CNS lesions according to RECIST 1.1 as assessed by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: OR according to RECIST 1.1 by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: Duration of OR according to RECIST 1.1 by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DC according to RECIST 1.1 by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: PFS according to RECIST 1.1 by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - All cohorts: Overall survival (OS), defined as time from first treatment administration until death from any cause
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - All Cohorts: Number of patients experiencing DLTs during the entire treatment period
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - All Cohorts: Change from baseline to Day 1 of Cycle 5 in EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) physical functioning domain score
Time frame: Baseline and on Day 1 of Cycle 5 (each cycle is 21 days).
Phase Ib - All Cohorts: Change from baseline to Day 1 of Cycle 5 in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score
Time frame: Baseline and on Day 1 of Cycle 5 (each cycle is 21 days).
Phase Ib - All Cohorts: Change from baseline to Day 1 of Cycle 5 in EORTC item List 46 (IL46) score
Time frame: Baseline and on Day 1 of Cycle 5 (each cycle is 21 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 41985129Heymach JV, Yamamoto N, Girard N, Ruiter G, Smit EF, Planchard D, Nadal E, Wu YL, Zugazagoitia J, Tu HY, Baik CS, Yoh K, Soo RA, Zhao Y, Sabari JK, Wermke M, Scheffler M, Ahn MJ, Fernamberg K, Schroeter L, Sadrolhefazi B, Thamer C, Eigenbrod-Giese S, Popat S; Beamion LUNG-1 Investigators. First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2026 Apr 30;394(17):1675-1684. doi: 10.1056/NEJMoa2516969. Epub 2026 Apr 15.
- Derived from this study: PubMed 40293180Heymach JV, Ruiter G, Ahn MJ, Girard N, Smit EF, Planchard D, Wu YL, Cho BC, Yamamoto N, Sabari JK, Zhao Y, Tu HY, Yoh K, Nadal E, Sadrolhefazi B, Rohrbacher M, von Wangenheim U, Eigenbrod-Giese S, Zugazagoitia J; Beamion LUNG-1 Investigators. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Jun 19;392(23):2321-2333. doi: 10.1056/NEJMoa2503704. Epub 2025 Apr 28.
- Derived from this study: PubMed 40030100Heymach JV, Opdam F, Barve M, Tu HY, Wu YL, Berz D, Schroter L, Botilde Y, Sadrolhefazi B, Serra J, Yoh K, Yamamoto N. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study. J Clin Oncol. 2025 Apr 10;43(11):1337-1347. doi: 10.1200/JCO-24-01727. Epub 2025 Mar 3.
- Derived from this study: PubMed 36528522Heymach J, Opdam F, Barve M, Gibson N, Sadrolhefazi B, Serra J, Yamamoto N. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. Clin Lung Cancer. 2023 Mar;24(2):e65-e68. doi: 10.1016/j.cllc.2022.10.008. Epub 2022 Nov 11.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
85 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing zongertinib in people with Neoplasm Metastasis and Non-Small Cell Lung Cancer, run by Boehringer Ingelheim at 85 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 51 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, China, Japan, France, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Maximum Tolerated Dose (MTD) (time frame: At the end of Cycle 1 (each cycle is 21 days).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886804, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.