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Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC) — SOLUTION  

Non-Squamous Non-small Cell Lung Cancer Clinical Trial

Official title:
Randomized Phase II Study of Durvalumab and Tremelimumab Combination Versus Standard of Care Following First-line Platinum Based Chemotherapy in Two Cohorts of Patients With Non Squamous and Squamous Non-small-cell Lung Cancer (NSCLC)

Clinical Trial Summary

This is a multicenter, 2-arm open-label, randomized comparative phase II study in each of two separate cohorts (non-squamous NSCLC and squamous NSCLC) according to histology.

Clinical Trial Description

Patients will receive four cycles of standard platinum-based doublet chemotherapy. Upon confirmation of response or tumor stabilization, patients will be registered and allocated into two cohorts based on the tumor histology and each cohort will be randomized into two arms. The experimental arm will receive combination of durvalumab + tremelimumab, the other arm is according to standard of care. The objective of this trial is to evaluate whether a maintenance approach with the combination immunotherapy with durvalumab + tremelimumab improves progression-free survival (PFS) compared to standard of care in patients with advanced NSCLC. Each cohort is powered separately based on PFS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03319316
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Withdrawn
Phase Phase 2
Start date November 1, 2018
Completion date November 2022
View Details
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