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A Single Arm Phase II Trial Evaluating the Activity of Alectinib for the Treatment of Pretreated RET-rearranged Advanced NSCLC - ALERT-lung

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologically or cytologically documented non-small cell lung carcinoma
- Advanced disease defined as
    - recurrent stage IV (according to 8th TNM classification) or
    - recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemo-radiation therapy for locally advanced disease)
- At least one prior platinum-based systemic regimen: Adjuvant or neoadjuvant or definitive platinum-based chemo-radiotherapy treatments are considered as a line of treatment only if completed less than 6 months before enrolment. Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate regimen of therapy.
- RET rearrangement detected by FISH, nanostring or by parallel-sequencing on FFPE tumour tissue assessed locally.
- Availability of FFPE tumour material for central confirmation of RETrearrangement
- Measurable or non-measurable, but radiologically evaluable (except for skin lesions) disease according to RECIST v1.1 criteria
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Life expectancy >3 months
- Adequate haematological function:
    - Haemoglobin ≥9 g/dL
    - Neutrophil count ≥1.5 ×109/L
    - Platelet count ≥100 × 109/L
- Adequate renal function: Calculated creatinine clearance ≥45 ml/min (according to Cockcroft-Gault)
- Adequate liver function:
    - Total bilirubin ≤2x ULN (except patients with Gilbert Syndrome, who can have total bilirubin ≤3.0 mg/dl)
    - ALT and AST ≤3x ULN (≤5x ULN for patients with concurrent liver metastasis)
 - Patient capable of proper therapeutic compliance, and accessible to correct followup.
- Women of childbearing potential (< 1 year without menstruation or < 2 years without menstruation following chemotherapy) must have a negative serum or urine pregnancy test within 7 days before beginning trial treatment.
- Sexually active men and women of childbearing potential must use an effective contraceptive method (intrauterine devices without hormones, bilateral tubal occlusion, vasectomized partner or total abstinence) during the trial treatment and
for a period of at least 28 days following the last administration of trial drug
 - Recovered from any previous therapy related toxicity to Grade ≤1 at date of enrolment (except for recovery to Grade ≤2 of alopecia, fatigue, creatinine increased, lack of appetite or peripheral neuropathy)
- Written Informed Consent (IC) for trial treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention.

Criteri di esclusione: 

- Untreated, active CNS metastases
- Carcinomatous meningitis
- Any previous (in the past 3 years) or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast
- Any serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes, that could affect the patient's capacity to participate in the trial
- Liver disease characterized by:
    - ALT or AST >3 × ULN (>5 × ULN for patients with concurrent liver metastasis) confirmed on two consecutive measurements or
    - Impaired excretory function (e.g., hyperbilirubinaemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminaemia, ascites, and bleeding from oesophageal varices or
    - Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis
- Patients with baseline symptomatic bradycardia
- Previous treatment with any RET TKI or RET targeted therapy.
- Known EGFR, ALK, ROS, and BRAF mutation (in addition to RET rearrangement)
- Any concurrent systemic anticancer therapy.
- Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post major bowel resection.
- Any concurrent systemic anticancer therapy

Trattamento sperimentale: 

Alectinib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

To assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1 in selected NSCLC patients with RET rearrangement.

Obiettivi secondari dello studio: 

The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free survival (PFS), and overall survival (OS) as well as to assess safety and tolerability of the treatment and to describe the association of primary and secondary outcomes with tumour characteristics.

Centri partecipanti

Nord Italia

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

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

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-002063-17

Data di inserimento: 30.06.2020

Promotore

European Thoracic Oncology Platform (ETOP)

CRO

/

Principal Investigator ITALIA

Istituto Europeo di Oncologia - Milano

Riferimento: Prof. Filippo De Marinis

Telefono: 0257489773

Email: filippo.demarinis@ieo.it

Localita: Milano

 

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