NCT03319316

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

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Squamous Non-small Cell Lung Cancer
• Non-Squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Combination of durvalumab + tremelimumab treatment
DRUG	Tremelimumab	Combination of durvalumab + tremelimumab treatment

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-11-01
• Completion: 2022-11-01
• First posted: 2017-10-24
• Last updated: 2022-01-10