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Studio di fase III, in aperto, randomizzato volto a valutare l’efficacia e la sicurezza di alectinib in regime adiuvante rispetto alla chemioterapia a base di platino in regime adiuvante in pazienti affetti da carcinoma polmonare non a piccole cellule positivo per la chinasi del linfoma anaplastico in stadio da IB (tumori > o = 4 cm) a IIIA resecato in toto - BO40336

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

Key Inclusion Criteria
- Age ≥18 years
- Complete resection of histologically confirmed Stage IB (tumor ≥ 4 cm) to Stage IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le Cancer / American Joint Committee on Cancer, 7th edition, with negative margins, at 4-12 weeks before enrollment
- If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred
- Documented ALK-positive disease according to an FDA-approved and CE-marked test
- Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines
- Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1
- Adequate hematologic and renal function
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy. Men must refrain from donating sperm during this same period
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Criteri di esclusione: 

Key Exclusion Criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
- Prior adjuvant radiotherapy for NSCLC
- Prior exposure to systemic chemotherapy and ALK inhibitors
- Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study
- Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
- Malignancies other than NSCLC within 5 years prior to enrollment, except for curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, ductal carcinoma in situ, papillary thyroid cancer, or any cured cancer that is considered to have no impact on disease free survival or overall survival for the current NSCLC
- Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
- Liver disease characterized by aspartate transaminase and alanine transaminase >= 3 × upper limit of normal or impaired excretory function or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices or acute viral or active autoimmune, alcoholic, or other types of acute hepatitis
- Japanese patients participating in the serial/intensive PK sample collection only: administration of strong/potent CYP450 3A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib up to Week 3
- Any exclusion criteria based on the local labels or guidelines for chemotherapy regimen
- Patients with symptomatic bradycardia
- History of organ transplant
- Known HIV positivity or AIDS-related illness
- Any clinically significant concomitant disease or condition that could interfere with-or for which the treatment might interfere with the conduct of the study or the absorption of oral medications or that would pose an unacceptable risk to the patients in this study, in the opinion of the Principal Investigator
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry

Trattamento sperimentale: 

Alectinib

Trattamento di controllo: 

Chemioterapia a base di platino

Obiettivi primari dello studio: 

Valutare l’efficacia di alectinib rispetto alla chemioterapia a base di platino in pazienti affetti da NSCLC ALK-positivo in stadio da IB (tumori ≥ 4 cm) a IIIA resecato in toto

Centri partecipanti

Nord Italia

ASST di Cremona
Viale Concordia 1 - 26100 Cremona - CR
A. O. Istituti Ospitalieri - S.C. Oncologia

Riferimento: Dr. Matteo Brighenti
Email: segreteria.oncologia@asst-cremona.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Divisione di Oncologia

Riferimento: Dr. Filippo De Marinis
Telefono: 0257489773
Email: filippo.demarinis@ieo.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Oncologia Medica

Riferimento: Dr. Luca Gianni
Telefono: 0226436529

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

Riferimento: Dr.ssa Alessandra Bearz
Telefono: 0434659294
Email: abearz@cro.it

 

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Oncologia Medica

Riferimento: Dr. Federico Cappuzzo
Telefono: 0544285206
Email: federico.cappuzzo@auslromagna.it

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO

Riferimento: Prof.ssa Silvia Novello
Telefono: 0119026978
Email: Silvia.novello@unito.it

 

Centro Italia

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG
Ospedale Santa Maria della Misericordia

Riferimento: Dr. Fausto Roila
Telefono: 0755784211
Email: roila.fausto@libero.it

 

AOU Pisana - Cisanello
Via Paradisa 2 - 56124 Pisa - PI
Dipartimento cardio-toracico - Pneumologia II

Riferimento: Dr. Antonio Chella
Email: a.chella@ao-pisa.toscana.it

 

Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM
UOC Pneumologia Oncologica I

Riferimento: Dr.ssa Maria Rita Migliorino
Telefono: 065554670
Email: mmigliorino@scamilloforlanini.rm.it

 

Sud Italia e isole

Azienda Ospedaliera Vincenzo Monaldi
Via Leonardo Bianchi 1 - 80131 Napoli - NA

Riferimento: Dr. Francovito Piantedosi
Telefono: 0817064086
Email: franco.piantedosi@ospedalemonaldi.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-004331-37

Data di inserimento: 04.02.2019

Promotore

F. Hoffmann-La Roche Ltd

CRO

/

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Dr. Filippo De Marinis

Telefono: 0257489773

Email: filippo.demarinis@ieo.it

Localita: Milano

 

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