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LATIFY - A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy (D533BC00001).

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC  Staging Manual in Thoracic Oncology.
- Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
- Documented radiological PD whilst on or after receiving the most recent treatment regimen.
- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
- Adequate organ function and marrow reserve
- Minimum life expectancy of 12 weeks.
- Body weight > 30 kg and no cancer-associated cachexia.
- Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

Criteri di esclusione: 

- Participant with mixed SCLC and NSCLC histology.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
- Participants:
    - Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
    - All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
    - Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
    - Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
- Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
- Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

Schema di trattamento: 

GROUP A: Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
GROUP B: Participants will be administered docetaxel (standard of care) administered intravenously. 

Trattamento sperimentale: 

Group A: Ceralasertib plus durvalumab combination therapy

Trattamento di controllo: 

Group B: Docetaxel monotherapy

Obiettivi primari dello studio: 

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

Note generali: 

NB: Oltre che nei Centri sotto elencati, lo studio è previsto anche nelle seguenti città:
- Catania (95123)
- Monza (20900)
- Napoli (80131)

Centri partecipanti

Nord Italia

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR

 

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

 

AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR

 

Centro Italia

Azienda USL 6 Livorno
Viale Alfieri 36 - 57124 Livorno - LI

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-000493-26 - NCT05450692

Data di inserimento: 18.12.2023

Promotore

AstraZeneca

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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