MO40653 - A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

Studio Clinico

Patologia: Carcinoma della vescica, Neoplasie del polmone

Osservazionale-Sperimentale: Osservazionale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: IV

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

- Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC: (1) As monotherapy for the treatment of adult patients with la/mUC after prior platinum-containing chemotherapy or (2) As monotherapy for the treatment of adult patients with la/mNSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving atezolizumab.
- Patient is prescribed atezolizumab therapy for the first time.
- Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice.
- Initiation of atezolizumab is not more than 28 days before signing informed consent. In countries where enrollment is only allowed after starting treatment, enrollment must be preceded by the administration of the first cycle of atezolizumab

Criteri di esclusione: 

- Treatment with atezolizumab for an indication that is not included in the study cohorts. Cisplatin ineligible participants receiving atezolizumab as first line of therapy for la/mUC will be excluded.
- Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date, as per locally approved Summary of Product Characteristics (SmPC).
- Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of an access or compassionate use program.

Trattamento sperimentale: 

Atezolizumab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The primary objective of this study, among patients initiating treatment with atezolizumab for the first time for approved indications, in routine clinical practice, is:
- To estimate overall survival (OS) at two years and at the end of the study

Obiettivi secondari dello studio: 

The secondary objectives, among patients initiating treatment with atezolizumab for the first time for approved indications in routine clinical practice, are:
- To evaluate the clinical benefit of atezolizumab.
- To estimate progression-free survival (PFS).
- To estimate the objective response rate (ORR), disease control rate (DCR), and duration of response (DoR).
- To evaluate health-related quality of life (HRQoL), during and after treatment.
- To describe patient baseline characteristics relevant to treatment and prognosis.
- To describe the characteristics of atezolizumab treatment.
- To determine the type, number and treatment duration of prior and subsequent cancer-related therapies.
- To estimate the time to initiation of subsequent cancer-related therapies following initiation of atezolizumab.
- To evaluate the impact of prior/subsequent anti-cancer therapies on outcomes.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03782207

Data di inserimento: 14.06.2019

Data di aggiornamento: 16.09.2025

Promotore

Hoffmann-La Roche

CRO

NA

Principal Investigator ITALIA

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milano

Riferimento: Dr. Francesco Grossi

Telefono: 0255032556

Email: francesco.grossi@policlinico.mi.it

Localita: Milano