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Protocol Number1479-0032
Not yet recruiting

2025-10-01 - 2035-01-20

Phase III

Recruiting6

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-3: A randomized, controlled, multicenter study evaluating zongertinib as adjuvant monotherapy versus standard of care in patients with early-stage, resectable non-small cell lung cancer (stage II–IIIB) harboring activating HER2 mutations in the tyrosine kinase domain.

  • Trial Applicant

    Boehringer Ingelheim

  • Sponsor

    Boehringer Ingelheim Taiwan Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Yen Tu Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔡鎮良 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Early, resectable non-small cell lung cancer (stage II to IIIB) with HER2 mutations involving activating alterations in the tyrosine kinase domain

Objectives

This study aims to demonstrate the superiority of zongertinib over physician’s choice of standard of care (immunotherapy or observation) in patients with resectable, early-stage, histologically confirmed non-squamous NSCLC (stage II–IIIB) harboring activating HER2 mutations in the tyrosine kinase domain (TKD), who have previously received neoadjuvant or adjuvant therapy.

Test Drug

Injection
Film-coated tablet
Injection
Injection
Injection

Active Ingredient

Durvalumab
Zongertinib (BI 1810631)
Pembrolizumab
Atezolizumab
Nivolumab

Dosage Form

270
116
270
270
270

Dosage

500mg/10ml
60 mg
25 mg/mL
1200mg/20mL
240mg/24mL

Endpoints

DFS as assessed by the investigator. DFS is defined as the time from randomization to the first documented tumor recurrence or death from any cause, whichever occurs first.

Inclution Criteria

Diagnosis
According to the 9th edition of the American Joint Committee on Cancer (AJCC) classification, patients must have undergone complete resection of the primary non-squamous NSCLC (stage II–IIIB, up to T4, N2) and have documented activating HER2 mutations in the tyrosine kinase domain (TKD).

Key Inclusion Criteria
• Age: Patients must be ≥18 years old or above the legal age of consent as defined by local regulations.
• Prior therapy: Before randomization, patients must have completed one of the following:
o 3–4 cycles of neoadjuvant platinum-based chemotherapy combined with immunotherapy. If immunotherapy is contraindicated due to a history or evidence of active autoimmune disease (excluding endocrine disorders), standard-of-care platinum doublet chemotherapy without immunotherapy may be allowed; or
o 4 cycles of adjuvant platinum-based chemotherapy. Patients who have completed at least 2 cycles but discontinued due to intolerable toxicity may also be eligible.
• Surgical resection: Complete surgical resection of the primary NSCLC must have been achieved and documented. Surgery must be performed via open or video-assisted thoracoscopic surgery (VATS); minimally invasive or robotic procedures are acceptable if standard oncologic and resection principles are maintained. All gross disease must be removed, and negative surgical margins must be confirmed by postoperative histopathological examination.
• HER2 mutation: Documented activating HER2 mutation in the TKD, preferably confirmed by next-generation sequencing (NGS) of tumor tissue.
• Histology and tumor specimens:
o Histologically confirmed diagnosis of primary NSCLC with non-squamous histology.
o Archived tumor tissue must be submitted to the central laboratory for retrospective confirmation of HER2 status after enrollment.
• Disease stage: Pre-treatment staging must not exceed stage IIIB (up to T4, N2) per AJCC 9th edition. Postoperative pathological stage must be stage II–IIIB (up to T4, N2).
• Recovery and timing prior to randomization:
o Complete recovery from surgery, including wound healing and recovery from prior therapy. Patients must be randomized within 2–8 weeks after the last adjuvant chemotherapy dose or within 4–10 weeks after surgery for neoadjuvant therapy. For adjuvant therapy, randomization must occur within 26 weeks after complete resection.
o At randomization, all toxicities related to prior therapy must have resolved to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia, stable sensory neuropathy, and hypothyroidism, which must have recovered to ≤ Grade 2.
• Performance status and organ function:
o Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
o Adequate organ function as determined by laboratory evaluations.

Exclusion Criteria

Key Exclusion Criteria
• Diagnosis of NSCLC with mixed histology and/or positive neuroendocrine markers (synaptophysin/CD56).
• Incomplete or unachieved surgical resection (R1 or higher).
• Receipt of preoperative or postoperative radiotherapy for primary NSCLC.
• Presence of concurrent actionable mutations with approved targeted therapies (e.g., epidermal growth factor receptor [EGFR] or anaplastic lymphoma kinase [ALK]).
• Any prior anticancer therapy other than standard neoadjuvant or adjuvant chemotherapy.
• Use of any investigational drug within 5 half-lives of the compound or any related agent (if known).
• Past or current history of:
o Active, known, or prior non-infectious interstitial lung disease/pneumonitis.
o Active infections requiring systemic therapy.
o Uncontrolled gastrointestinal disorders affecting drug intake or absorption.
o Malignancy within the past 3 years, except for specific cancers that have been effectively treated.
o Severe and/or uncontrolled cardiovascular abnormalities, QT interval corrected by Fredericia’s formula (QTcF) >470 ms, or left ventricular ejection fraction (LVEF) <50%.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    400 participants

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