Clinical Trials List
Protocol Number1479-0008
NCT Number(ClinicalTrials.gov Identfier)NCT06151574
Active
2024-01-15 - 2029-12-31
Phase III
Recruiting5
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
Beamion LUNG-2: A Phase III, open-label, randomized, active- controlled, multi-centre trial evaluating orally administered zongertinib (BI 1810631) compared with standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic non- squamous non-small cell lung cancer harbouring HER2 tyrosine kinase domain mutations
-
Trial Applicant
Boehringer Ingelheim
-
Sponsor
BOEHRINGER INGELHEIM TAIWAN LTD.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/12/04
Investigators and Locations
Co-Principal Investigator
- 廖斌志 無
- 陳冠宇 無
- 楊景堯 無
- 黃信端 無
- Chia-Chi Lin 無
- 黃得瑞 無
- Chong-Jen Yu 無
- 許嘉林 無
- 黃俊凱 無
- James Chih-Hsin Yang 無
- 林宗哲 無
- YEN-TING LIN 無
- 廖唯昱 無
- 錢穎群 無
- 徐偉勛 無
- 吳尚俊 無
- CHAO-CHI HO CHAO-CHI HO 無
- 蔡子修 無
- Jih-Hsiang Lee 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Chi Lin 無
- 林宗哲 無
- WEI-LI MA 無
- 吳尚俊 無
- JIN-YUAN SHIH 無
- 廖斌志 無
- YEN-TING LIN 無
- 黃得瑞 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Cheng-Ta Yang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
unresectable, locally advanced or metastatic non- squamous non-small cell lung cancer harbouring HER2 tyrosine kinase domain mutations
Objectives
The primary objective of the trial is to show superiority of zongertinib (BI 1810631) over SoC (pembrolizumab plus platinumpemetrexed chemotherapy) based on the hazard ratio of progressionfree survival (PFS) in patients diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 TKD mutations who have not received any systemic treatment in this setting.
The key secondary objectives are to show superiority of zongertinib (BI 1810631) over SoC in terms of the difference in objective
response (OR), to show superiority of zongertinib (BI 1810631) over SoC based on the change from baseline at Week 25 in the NSCLC SAQ total score, and to show superiority of zongertinib (BI 1810631) over SoC based on the hazard ratio of overall survival
(OS).
Secondary objectives are to evaluate additional efficacy parameters, further patient reported outcomes (PROs), and safety of zongertinib (BI 1810631) compared with SoC.
Test Drug
Zongertinib
Active Ingredient
Zongertinib
Dosage Form
tablets
Dosage
60 mg
Endpoints
The primary endpoint is PFS according to RECIST 1.1 determined by blinded central independent review. PFS is defined as the time
from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.
The key secondary endpoints are OR according to RECIST 1.1, determined by blinded central independent review, the change from
baseline to Week 25 of NSCLC-SAQ total score, and OS. OR is defined as confirmed best overall response of complete response
(CR) or partial response (PR), where best overall response is determined according to RECIST 1.1 from date of randomization
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. OS is defined as the time from randomization until death from any cause.
from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.
The key secondary endpoints are OR according to RECIST 1.1, determined by blinded central independent review, the change from
baseline to Week 25 of NSCLC-SAQ total score, and OS. OR is defined as confirmed best overall response of complete response
(CR) or partial response (PR), where best overall response is determined according to RECIST 1.1 from date of randomization
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. OS is defined as the time from randomization until death from any cause.
Inclution Criteria
Main inclusion criteria
• Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).
• Histologically or cytologically confirmed diagnosis of advanced and/or metastatic non-squamous NSCLC.
• Documented HER2 mutation in the TKD (incl. specific amino acid sequence information) as per existing local lab result preferably by tissue NGS/PCR, but also ctDNA.
• Availability of archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status.
• Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy. Prior neoadjuvant and/or adjuvant chemotherapy or immunotherapy is allowed if the treatment was completed more than 6 months prior to disease progression.
• Presence of at least one measurable non-CNS lesion according to RECIST 1.1, as determined by the local site investigator/radiology assessment. Patients with asymptomatic (i.e. no clinical [neurological] symptoms) brain lesions are eligible.
• Eligible to receive treatment with the selected platinumbased doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summary of Product Characteristics/Product Information.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
• Adequate organ function based on laboratory values.
• Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).
• Histologically or cytologically confirmed diagnosis of advanced and/or metastatic non-squamous NSCLC.
• Documented HER2 mutation in the TKD (incl. specific amino acid sequence information) as per existing local lab result preferably by tissue NGS/PCR, but also ctDNA.
• Availability of archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status.
• Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy. Prior neoadjuvant and/or adjuvant chemotherapy or immunotherapy is allowed if the treatment was completed more than 6 months prior to disease progression.
• Presence of at least one measurable non-CNS lesion according to RECIST 1.1, as determined by the local site investigator/radiology assessment. Patients with asymptomatic (i.e. no clinical [neurological] symptoms) brain lesions are eligible.
• Eligible to receive treatment with the selected platinumbased doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summary of Product Characteristics/Product Information.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
• Adequate organ function based on laboratory values.
Exclusion Criteria
Main exclusion criteria
• Tumors with targetable alterations with approved available therapy.
• Presence or history of uncontrolled or symptomatic brain and subdural metastases, unless considered stable by the investigator and local therapy was completed and patients with known leptomeningeal disease.
• Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
• Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy completed 2 weeks prior to treatment start.
• Major surgery (major according to the investigator’s assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening.
• Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.
• History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.
• Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms.
• Mean resting corrected QT interval (QTcF) >470 msec.
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-ofage.
• Ejection fraction <50% or the lower limit of normal of theinstitutional standard, whatever is lower.
•Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis.
•Any history or presence of uncontrolled gastrointestinal disorders that could affect the intake and/or absorption of the trial drug in the opinion of the investigator.
• Tumors with targetable alterations with approved available therapy.
• Presence or history of uncontrolled or symptomatic brain and subdural metastases, unless considered stable by the investigator and local therapy was completed and patients with known leptomeningeal disease.
• Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
• Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy completed 2 weeks prior to treatment start.
• Major surgery (major according to the investigator’s assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening.
• Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.
• History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.
• Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms.
• Mean resting corrected QT interval (QTcF) >470 msec.
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-ofage.
• Ejection fraction <50% or the lower limit of normal of theinstitutional standard, whatever is lower.
•Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis.
•Any history or presence of uncontrolled gastrointestinal disorders that could affect the intake and/or absorption of the trial drug in the opinion of the investigator.
The Estimated Number of Participants
-
Taiwan
7 participants
-
Global
270 participants
