Last updated 36 days ago
A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)
278 patients around the world
Available in Spain, Brazil, Argentina, United States, Mexico
Bayer
16Research sites
278Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Sites
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Centro Médico Privado CEMAIC - Córdoba
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Instituto Argentino de Diagnóstico y Tratamiento - IADT
Fundación CENIT para la Investigación en Neurociencias
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Hospital De Base de São José do Rio Preto - CIP São José
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Hospital de Câncer de Barretos - Fundação PIO XII
StudySOHO-02
SponsorBayer
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06452277
