Patologia: Neoplasie del polmone
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Linee di trattamento: Prima linea
Criteri di inclusione:
1. Signed and dated written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
2. Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC).
4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
5. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor.
6. Patients who have not received any systemic treatment for locally advanced or metastatic disease.
7. Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment.
8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summaries of Product Characteristics (SmPC)/Product Information.
Criteri di esclusione:
1. Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except;
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local treatment
2. Tumors with targetable alterations with approved available therapy.
3. Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
4. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
5. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement.
6. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.
7. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.
8. Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.
Trattamento sperimentale:
BI 1810631
Trattamento di controllo:
SoC 1st Line
Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR
UO Oncologia Medica - NB: Arruolamento pazienti non ancora attivo
IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO
UO Oncologia Medica
Ospedale di Circolo Fondazione Macchi
Viale Luigi Borri 57 - 21100 Varese - VA
UO Oncologia - NB: Arruolamento pazienti non ancora attivo
Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM
UO Oncologia A
Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA
UO Oncologia Medica - NB: Arruolamento pazienti non ancora attivo
AOU Policlinico Vittorio Emanuele PO G. Rodolico
Via S. Sofia 78 - 95123 Catania - CT
UO Oncologia Medica - NB: Arruolamento pazienti non ancora attivo
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
SC Oncologia Clinica Sperimentale Toraco-Polmonare - NB: Arruolamento pazienti non ancora attivo
Numero di iscrizione a registro: 2023-504308-27-00
Data di inserimento: 25.10.2024
Boehringer Ingelheim
IQVIA
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na