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Clinical Trials List

Protocol Number1479-0032
Active

2025-10-01 - 2035-01-20

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 trial evaluating zongertinib as adjuvant monotherapy versus standard of care in patients with early-stage, resectable non-small cell lung cancer (stage II-IIIB) and HER2 mutations with activated tyrosine kinase domain.

  • Trial Applicant

    Boehringer Ingelheim

  • Sponsor

    Boegringer Ingelheim Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/15

Investigators and Locations

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

DFS as assessed by the trial administrator. DFS is defined as the time elapsed from randomization until tumor recurrence or death from any cause (whichever occurs earlier).

Objectives

This trial aims to demonstrate that zongertinib is superior to physician-selected standard care (immunotherapy or observation) in patients diagnosed with resectable, early histologically confirmed non-squamous NSCLC, stage II-IIIB, with HER2 mutations activating TKD, and who have previously received pre-adjuvant or adjuvant therapy.

Test Drug

Imfinzi®
KEYTRUDA®
OPDIVO
Tecentriq®
Zongertinib (BI 1810631)

Active Ingredient

Durvalumab
Pembrolizumab
Nivolumab
Atezolizumab
Zongertinib (BI 1810631)

Dosage Form

Injectables
Injectables
Injectables
Injectables
Film-coated tablets

Dosage

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

Endpoints

DFS as assessed by the trial administrator. DFS is defined as the time elapsed from randomization until tumor recurrence or death from any cause (whichever occurs earlier).

Inclution Criteria

Diagnosis
According to the 9th edition of the American Joint Committee on Cancer (AJCC) classification, patients must have completely resected primary non-squamous NSCLC (stage II-IIIB, up to T4, N2) and must have a documented TKD-activated HER2 mutation.

Main Inclusion Criteria

• Patients must be ≥ 18 years of age or older than the legal consent age in their country.

• Pre-treatment: Prior to randomization, patients must have completed one of the following:

o 3–4 cycles of adjuvant platinum-based chemotherapy combined with immunotherapy. If immunotherapy is contraindicated due to a history or evidence of active autoimmune disease (excluding endocrine disorders), standard care chemotherapy doublet therapy may be permitted without immunotherapy.

or
o 4 cycles of adjuvant platinum-based chemotherapy (patients may also be eligible for the trial if they have completed at least two cycles of chemotherapy but had to discontinue due to intolerable side effects).

• Surgical resection: Complete surgical resection of primary NSCLC is required and must be documented as achievable. Surgery must be performed using open or image-assisted thoracoscopic surgery (VATS) techniques (minimally invasive/robotic procedures may be considered if standard oncology and resection principles are adhered to). All grossly visible lesions must be removed, and postoperative histopathological examination must confirm negative resection margins.

• HER2 mutation: Documented HER2 mutations with TKD activation, preferably confirmed by next-generation sequencing (NGS).

• Histology and tumor specimens:

o Histologically confirmed primary NSCLC with non-squamous histological features.

• Upon patient enrollment, a stock of tumor tissue specimens must be submitted to the central laboratory for retrospective confirmation of HER2 status.

• Staging: According to the 9th edition of the AJCC classification, the pre-treatment classification must not exceed stage IIIB (maximum T4, maximum N2). Post-operative classification must be stage II-IIIB (maximum T4, maximum N2).

• Time elapsed before recovery/randomization:

o Complete postoperative recovery, including wound healing and recovery from prior treatment. Patients must be able to be randomized within 2–8 weeks of their last adjuvant chemotherapy or within 4–10 weeks of surgery prior to adjuvant therapy. Patients receiving adjuvant therapy must be randomized no more than 26 weeks after complete surgical resection.

• At the time of randomization, patients must have recovered from any prior therapy-related toxicities to ≤ CTCAE Grade 1 (excluding alopecia, stable sensory neuropathy, and hypothyroidism, which must recover to ≤ CTCAE Grade 2).

• Performance status and organ function:

• East Coast Cancer Clinical Research Consortium (ECOG) score of 0 or 1

• Adequate organ function based on laboratory test values

Exclusion Criteria

Key Exclusion Criteria

• NSCLC diagnosed with mixed histological features/positive neuroendocrine markers (synaptophysin/CD56)

• Incomplete or inadequate surgical resection (R1 or higher)

• Use of preoperative or postoperative radiation therapy for primary NSCLC

• Concurrent actionable mutations with approved targeted therapy (e.g., epidermal growth factor receptor [EGFR] or anaplastic lymphoma kinase [ALK])

• Any prior anticancer therapy other than standard pre-adjuvant or adjuvant chemotherapy

• Use of any investigational drug within 5 half-lives of this compound or any of its related substances (if known)

• Past or present history of:
o Active or known pre-existing or past non-infectious interstitial lung disease/pneumonia
o Active infectious disease requiring systemic therapy
o Uncontrolled gastrointestinal disease affecting drug uptake/absorption
o Malignancy diagnosed or concurrently diagnosed within the past 3 years, excluding certain cancers that have been effectively treated
o Severe and/or uncontrolled cardiovascular abnormalities, after Fredericia formula correction QT interval (QTcF) > 470 milliseconds, or ejection fraction < 50%

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    400 participants

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