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NCT06452277Recrutement en cours

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

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Résumé

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing. The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation. The study participants will receive one of the study treatments: * Sevabertinib as a tablet taken by mouth twice a day * Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover. Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the research team will: * do scans such as CT, PET, MRI, or X-rays to check the cancer * Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram. * do pregnancy tests when needed * ask how the participants are feeling and whether they have had any adverse events or other health problems An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Critères d'inclusion

• 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.

Critères d'exclusion

• 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.

Contacts

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

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Statut
Recrutement en cours
Phase
Phase 3
Type d'étude
Interventionnelle
Pays
Suisse, France, Allemagne, Italie, Autriche, États-Unis, Argentine, Australie, Belgique, Brésil, Bulgarie, Canada, Chine, Tchéquie, Danemark, Finlande, Grèce, Hong Kong, Hongrie, Israël, Japon, Malaisie, Mexique, Pays-Bas, Pologne, Portugal, Roumanie, Singapour, Slovaquie, Corée du Sud, Espagne, Suède, Taïwan, Turquie, Ukraine, Royaume-Uni
Promoteur
Bayer(Industrie)
N° de protocole
22615
Pathologies
Advanced Non-small Cell Lung Cancer, HER2 Mutation
Interventions
Médicament

Traitements évalués

  • Sevabertinib
  • Pembrolizumab
  • Cisplatin
  • Carboplatin
  • Pemetrexed

Lieux · 38

  • San Francisco, États-UnisUCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and OncologyRecrute dans ce centre
  • Santa Monica, États-UnisUCLA Health Santa Monica Cancer CareRecrute dans ce centre
  • Fort Lauderdale, États-UnisThe Oncology Institute of Hope and Innovation - Fort Lauderdale 17th StreetRecrute dans ce centre
  • Atlanta, États-UnisPiedmont Healthcare - AtlantaRecrute dans ce centre
  • Columbus, États-UnisJohn B. Amos Cancer CenterRecrute dans ce centre
  • Chicago, États-UnisUniversity of Illinois Hospital - Outpatient Cancer Care CenterRecrute dans ce centre
  • Cincinnati, États-UnisUC Medical Center - OncologyRecrute dans ce centre
  • Maumee, États-UnisTaylor Cancer Research CenterRecrute dans ce centre
  • Pittsburgh, États-UnisAllegheny General HospitalRecrute dans ce centre
  • Houston, États-UnisThe University of Texas MD Anderson Cancer Center - Texas Medical CenterRecrute dans ce centre
  • Fortaleza, BrésilPronutrir Fortaleza - CERecrute dans ce centre
  • Brasília, BrésilCentro Paulista de Oncologia (CPO) - Sao Paulo - Faria LimaRecrute dans ce centre
  • Recife, BrésilRede DoR Recife - PERecrute dans ce centre
  • Natal, BrésilLiga Norte Riograndense Contra o Cancer | Centro de Pesquisa ClínicaRecrute dans ce centre
  • Blumenau, BrésilCentro de Pesquisa da Clínica de Oncologia ReichowRecrute dans ce centre
  • Bauru, BrésilNAIC - Instituto do CancerRecrute dans ce centre
  • Jaú, BrésilFundacao Pio XII - Hospital de Cancer de BarretosRecrute dans ce centre
  • São Paulo, BrésilHospital Sirio LibanesRecrute dans ce centre
  • São Paulo, BrésilA Beneficencia Portuguesa de Sao Paulo - Hospital BP MiranteRecrute dans ce centre
  • São Paulo, BrésilIrmandade Santa Casa de Misericordia de Porto Alegre | OncologyRecrute dans ce centre
  • Sofia, BulgarieMultiprofile Hospital for Active Treatment "Sveta Sofia"Recrute dans ce centre
  • Brampton, CanadaBrampton Civic Hospital | OncologyRecrute dans ce centre
  • Toronto, CanadaPrincess Margaret Cancer Centre | Medical Oncology and HematologyRecrute dans ce centre
  • Montreal, CanadaJewish General Hospital | Pulmonary OncologyRecrute dans ce centre
  • Brno, TchéquieMasarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)Recrute dans ce centre
  • Hong Kong, Hong KongPrince of Wales HospitalRecrute dans ce centre
  • Hong Kong, Hong KongQueen Elizabeth Hospital Hong KongRecrute dans ce centre
  • Sapporo, JaponHokkaido University HospitalRecrute dans ce centre
  • Matosinhos Municipality, PortugalHospital Pedro Hispano | Clinical Research CenterRecrute dans ce centre
  • Lisbon, PortugalCHULN - Hospital Pulido ValenteRecrute dans ce centre

Au total, dans le monde, 38 des 279 centres listés au registre recrutent ; les 241 autres ne recrutent pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 15 octobre 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

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Autres identifiants

  • 2024-511319-91-00 · autre identifiant

Voir aussi

Autres versions

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