Informations générales (source: ClinicalTrials.gov)
A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations (SOHO-02)
Interventional
Phase 3
Bayer (Voir sur ClinicalTrials)
août 2024
mai 2028
16 novembre 2024
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 is a group of lung cancers that have spread to nearby tissues or to other
parts of the body or that are unlikely to be cured or controlled with currently available
treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called
mutation) to the building plans (genes) for this protein in cancer cells leads to a
production of abnormal HER2 and therefore abnormal cell growth and division.
The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may
stop the spread of NSCLC.
The main purpose of this study is to learn how well BAY 2927088 works and how safe it is
compared with standard treatment, in participants who have advanced NSCLC with specific
genetic changes called HER2 mutations.
The study participants will receive one of the study treatments:
- BAY 2927088 twice every day as a tablet by mouth, or
- Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The
treatment will continue for as long as participants benefit from it without any
severe side effects or until they or their doctor decide to stop the treatment.
During the study, the doctors and their study team will:
- take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the
body to study the spread of cancer
- check the overall health of the participants by performing tests such as blood and
urine tests, and checking
- heart health using an electrocardiogram (ECG)
- perform pregnancy tests for women
- ask the participants questions about how they are feeling and what adverse events
they are having.
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:11 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Jaafar BENNOUNA | 23/12/2024 08:04:38 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Rouen - Pneumologie - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble Alpes - Pneumologie - La Tronche - France | Contact (sur clinicalTrials) | ||||
| CHU Limoges - Unité oncologie thoracique - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital Arnaud de Villeneuve - Montpellier - 34059 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hôpital Emile Muller - Mulhouse - 68051 - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| Hôpital Lyon Sud - HCL - Service de pneumologie aiguë spécialisée et cancérologie thoracique - 69495 - Pierre Bénite - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - Unicancer Nouvelle Aquitaine - 33076 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut Coeur Poumon - CHRU Lille - Pôle Cardio-vasculaire et pulmonaire - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Saint Herblain - 44800 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie et d'Imagerie - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.