Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

Official Title

An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON).

Summary:

This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

Trial Description

Primary Outcome:

• Assessment of the efficacy of each treatment by evaluation of objective response rate

Secondary Outcome:

• Disease control rate (DCR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.
• Best percentage change in tumour size using RECIST 1.1 assessment for the anti-tumour activity of each therapy
• Duration of response (DoR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.
• Progression free survival (PFS) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.
• Overall surival (OS)

This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on an anti-programmed cell death-1/anti-programmed cell death ligand 1 (anti-PD-1/PD-L1) containing therapy. This study is modular in design, consisting of a number of treatment cohorts, allowing evaluation of the efficacy, safety, and tolerability of multiple treatment arms. There is currently no established therapy for patients who have received immune checkpoint inhibitors and platinum-doublet therapies, and novel treatments are urgently needed. This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment.

View this trial on ClinicalTrials.gov