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

Phase 3

Recruiting

• Conditions: Lung Cancer, Non-squamous, Non-small Cell
• Interventions: Drug: pembrolizumab; Drug: zongertinib; Drug: cisplatin; Drug: carboplatin; Drug: pemetrexed

• Registration Number: NCT06151574
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-11-30
• Study Start: 2024-02-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-11-01
• Study Completion: 2028-01-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator arm	carboplatin	pembrolizumab plus platinum-pemetrexed chemotherapy
Comparator arm	pembrolizumab	pembrolizumab plus platinum-pemetrexed chemotherapy
Comparator arm	cisplatin	pembrolizumab plus platinum-pemetrexed chemotherapy
Comparator arm	pemetrexed	pembrolizumab plus platinum-pemetrexed chemotherapy
Experimental treatment arm	zongertinib	zongertinib only

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review	up to 4 years and 5 months	PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.

Secondary Outcome Measures

Name	Time	Method
Key secondary endpoint: Overall Response (OR) according to RECIST 1.1 determined by blinded central independent review	up to 53 months	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.
Key secondary endpoint: Change from baseline to Week 25 of Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score	at baseline, at week 25	The NSCLC-SAQ is a 7-item patient-reported outcome measure for use in adults to assess symptoms of advanced NSCLC.; It contains five domains and accompanying items that were identified as symptoms of NSCLC: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1).; The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms.
Key secondary endpoint: Overall Survival (OS)	up to 53 months	OS is defined as the time from randomization until death from any cause.
Duration of response (DoR), determined by blinded central independent review	up to 53 months	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.
PFS determined by blinded central independent review	up to 53 months	PFS is defined as the time from randomization until tumor progression or death from any cause, whichever occurs earlier.
Bi-compartmental PFS, determined by blinded central independent review	up to 53 months	Bi-compartmental PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.
OR determined by blinded central independent review	up to 53 months	OR is defined as confirmed best overall response of CR or PR, from date of randomization until the earliest progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.
Change from baseline to Week 25 in the NSCLC-SAQ pain domain score	at baseline, at week 25	The individual NSCLC-SAQ items use a five-point verbal rating scale from "No \<symptom\> At All" to "Very severe \<symptom\>" or from "Never to Always," corresponding to an (item) score of 0 to 4. A higher score indicates more severe symptoms.
Change from baseline to Week 25 in the NSCLC-SAQ dyspnea domain score	at baseline, at week 25
Change from baseline to Week 25 in the NSCLC-SAQ cough domain score	at baseline, at week 25
Change from baseline to Week 25 in the NSCLC-SAQ appetite domain score	at baseline, at week 25
Change from baseline to Week 25 in the NSCLC-SAQ fatigue domain score	at baseline, at week 25
Change from baseline to Week 25 in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) physical functioning domain score	at baseline, at week 25	The EORTC QLQ-C30 is a quality of life questionnaire. It ranges from 0 to 100, higher scores equal worse outcome.
Occurrence of adverse events (AEs) during the on-treatment period, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	up to 53 months
Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0	up to 53 months

Trial Locations

Locations (168)

Clearview Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

Mohtaseb Cancer Center and Blood Disorders, LLC; 🇺🇸 Bullhead City, Arizona, United States

Precision NextGen Oncology; 🇺🇸 Beverly Hills, California, United States

ClinRé 001-022 (Premier Cancer Care and Infusion Center); 🇺🇸 Fresno, California, United States

OPN Healthcare, Inc.; 🇺🇸 Glendale, California, United States

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

Valkyrie Clinical Trials; 🇺🇸 Los Angeles, California, United States

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

St. Louis Cancer Care, LLP; 🇺🇸 Bridgeton, Missouri, United States

Oncology Hematology Associates; 🇺🇸 Springfield, Missouri, United States

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