Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B, unresectable, NSCLC, treated with definitive Chemo-Radiotherapy
This is an Italian multi-center randomized phase II trial (randomization 2:1) of intravenous (IV) MK-3475 (Pembrolizumab) versus observation as a maintenance therapy after chemo-radiotherapy (either concomitant or sequential, regardless of the type of chemotherapy used) in unresectable stage IIIA-IIIB non small cell lung cancer (NSCLC) patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
Pembrolizumab Injectable Product 200 mg Q3W Intravenous
CRO Aviano
Aviano, Pordenone, Italy
AOU San Luigi- Department of Oncology
Orbassano, Turin, Italy
Istituto Tumori Giovanni Paolo II
Bari, Italy
OS
The primary objective is to evaluate if treatment with chemo-radiotherapy followed by Pembrolizumab (MK-3475) maintenance (up to 24 months) results in superior Overall Survival (OS) in stage IIIA-B, unresectable, NSCLC compared to chemo-radiotherapy (CT-RT) followed by observation
Time frame: up to 24 months per patient
PFS
To evaluate Rate (%) of patients without disease progression at 12, 18 and 24 months
Time frame: up to 24 months per patient
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Chieti Università degli Studi "G. D'Annunzio"
Chieti, Italy
AOU Careggi
Florence, Italy
IRCCS AO San Martino
Genova, Italy
Azienda Ospedaliera Papardo
Messina, Italy
Istituto Clinico Humanitas
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Policlinico Modena
Modena, Italy
...and 4 more locations