Evaluating BAY 2927088 for Advanced Lung Cancer with HER2 Mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness and safety of BAY 2927088 in treating patients with advanced non-small cell lung cancer (NSCLC) that has specific mutations in the HER2 gene. Participants will receive BAY 2927088 and its performance will be compared to standard treatments such as Pembrolizumab, Cisplatin, Carboplatin, and Pemetrexed. The study focuses on patients who have not received prior systemic therapy for their advanced disease. Researchers hope to determine if blocking the mutated HER2 protein can halt the progression of NSCLC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
* Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
* Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
* No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
* Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.

Exclusion Criteria:

* Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:

  * a. in situ cancers of cervix, breast, or skin,
  * b. superficial bladder cancer (Ta, Tis and T1),
  * c. limited-stage prostate cancer,
  * d. basal or squamous cancers of the skin.
* Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
* Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \>4 weeks prior to planned start of study intervention.
* Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).
* History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
* Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Where it's running

• UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology
  San Francisco, California, United States Recruiting
• UCLA Health Santa Monica Cancer Care
  Santa Monica, California, United States Recruiting
• The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street
  Fort Lauderdale, Florida, United States Recruiting
• Piedmont Healthcare - Atlanta
  Atlanta, Georgia, United States Recruiting
• John B. Amos Cancer Center
  Columbus, Georgia, United States Recruiting
• University of Illinois Hospital - Outpatient Cancer Care Center
  Chicago, Illinois, United States Recruiting

+229 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sevabertinib in HER2-mutant Advanced NSCLC: Real-world Outcomes

  This study looks at how Sevabertinib works in real-world adults with HER2-mutant advanced NSCLC who have had prior treatment, to see its effectiveness, safety, and impact on quality of life.

  Recruiting Ruijin Hospital · Qionghai, Hainan · NCT07880353

• Treatment for solid tumors with HER2 mutations using BAY2927088 tablets

  This study is testing if BAY2927088 tablets can help people with advanced solid tumors that have HER2 gene mutations feel better and manage their cancer.

  Recruiting at 33 sites Phase 2 Bayer · Birmingham, Alabama and 53 other locations · NCT06760819

• Acoramidis in adults with transthyretin amyloid cardiomyopathy in France

  This is an observational study to see how acoramidis is used in everyday care for adults with ATTR‑CM in France and how it affects their quality of life and daily function.

  Recruiting Bayer · Many Locations · NCT07791160

• How your body handles two forms of elinzanetant in healthy women

  This study tests whether a new tablet form of elinzanetant is absorbed and processed by the bodies of healthy women in the same way as an existing capsule form.

  Recruiting Phase 1 Bayer · Mount Royal, Quebec · NCT07762287

• Heart-risk in older men with advanced prostate cancer treated with enzalutamide or darolutamide

  This observational study tests whether heart-related risks differ for older men with advanced prostate cancer treated with enzalutamide or darolutamide.

  Recruiting Bayer · Whippany, New Jersey · NCT07672119

• How safe BAY3389934 is when given alone or with aspirin in healthy adults

  This study tests BAY3389934, alone and with aspirin, to see if it’s safe and how it affects blood clotting in healthy adults.

  Recruiting Phase 1 Bayer · Miami, Florida · NCT07652723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.