Trial comparing treatments for Non-small Cell Lung Cancer
Official title Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
ClinicalTrials.gov ID: NCT07195695
What this study is testing
What is Zongertinib?
Zongertinib is an investigational oral medicine being studied as a potential adjuvant treatment for adults with completely resected Stage II-IIIB non‑small cell lung cancer that has HER2 tyrosine kinase domain mutations. Zongertinib is designed to target HER2 signaling pathways in cancer cells.
Also referred to as BI 1810631, Hernexeos®.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether zongertinib can keep people cancer‑free longer after surgery compared with usual follow‑up or other standard treatments. It also looks at safety and how patients feel during treatment.
- Who it's for
- Adults who had surgery to remove all visible stage II‑IIIB non‑small cell lung cancer and whose tumors have a HER2 mutation.
- What's involved
- Participants will take either zongertinib by mouth or the standard treatment chosen by their doctor. They will have regular clinic visits and tests to monitor cancer status and side effects.
- Time commitment
- The study lasts about 3 years, with visits every few months to check on health and cancer recurrence.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Patients must be ≥18 years old or over the legal age of consent in their country
- 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...
- HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
- Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
You likely can't join if
- Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
- Treatment with radiation therapy for primary NSCLC
- Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
- Any investigational drug within 5 half-lives of the compound or any of its related material, if known
- History or presence of
See the full eligibility criteria
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Patients must be ≥18 years old or over the legal age of consent in their country
- 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...
- HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
- Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
- An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
- Staging: Pretherapeutic classification not exceeding Stage IIIB
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate organ function based on laboratory values Further apply.
- Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
- Treatment with radiation therapy for primary NSCLC
- Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
- Any investigational drug within 5 half-lives of the compound or any of its related material, if known
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Fresno, California, United States
- Glendale, California, United States
- Orange, California, United States
- Roseville, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Orange City, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Lisle, Illinois, United States
- Boston, Massachusetts, United States
- Reno, Nevada, United States
- New York, New York, United States
- Portland, Oregon, United States
- Abilene, Texas, United States
- Ogden, Utah, United States
- Fairfax, Virginia, United States
- CABA, Argentina
- Ciudad Autónoma de Bs As, Argentina
+ 122 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fresno, California, United States; Glendale, California, United States; Orange, California, United States; Roseville, California, United States; San Francisco, California, United States; Santa Monica, California, United States and 136 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.