RightFit
RecruitingPhase 3

Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After completing surgery and required systemic treatment, eligible participants are randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years, or standard treatment, which may include an approved adjuvant immunotherapy agent administered according to its label, or observation, depending on local clinical practice and patient status."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether zongertinib, a pill that targets HER2, helps people stay cancer-free longer than standard care after surgery. It is for adults with stage II–IIIB non-small cell lung cancer (NSCLC) with a certain HER2 gene change, whose cancer was fully removed and who had required chemotherapy. Standard care may be immune treatment or close monitoring without treatment.

Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before joining. You must be at least 18 or meet your country's legal age for consent.
  • Have stage II–IIIB NSCLC confirmed by a tissue test, with a HER2 TKD gene change that makes HER2 more active.
  • Have had surgery to fully remove the cancer and required platinum-based chemotherapy before or after surgery. Treatment before surgery may also include immune treatment.
  • Provide a stored tumor sample so the study lab can check the HER2 gene change.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have organs that work well enough, based on lab tests.
  • If you can become pregnant, be willing and able to use two highly effective birth control methods.
  • Other study entry rules apply.

Who can't join

  • Have NSCLC with mixed cell types or positive tests for certain nerve-and-hormone cell markers.
  • Had major surgery within 4 weeks before being assigned to a study group, or had radiation for the main lung cancer.
  • Have another gene change, such as EGFR or ALK, with an approved targeted treatment.
  • Recently used an experimental drug. The waiting time depends on how long the drug and related substances stay in the body.
  • Have or have had lung inflammation or scarring not caused by infection, or have an active infection needing medicine that works throughout the body.
  • Have uncontrolled stomach or bowel problems that affect taking or absorbing medicine.
  • Have had another cancer within the past 3 years, except certain cancers treated successfully.
  • Have serious or uncontrolled heart problems, including certain abnormal heart rhythm tests or a heart pumping measure below 50%. Other exclusion rules apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 2. Patients must be ≥18 years old or over the legal age of consent in their country 3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol 4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations 5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC 6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status 7. Staging: Pretherapeutic classification not exceeding Stage IIIB 8. Performance status and organ function: * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Adequate organ function based on laboratory values Further inclusion criteria apply. Exclusion criteria: 1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56) 2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization 3. Treatment with radiation therapy for primary NSCLC 4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK)) 5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known 6. History or presence of * Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis * Active infectious disease requiring systemic therapy * Uncontrolled gastrointestinal disorders affecting drug intake/absorption * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers * Significant and/or uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \>470 msec, or ejection fraction \<50% Further exclusion criteria apply.

Study sites (27)

CA

DC

FL

GA

ID

IL

MA

NC

NV

NY

OR

TX

UT

VA