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 modified RECIST 1.1 assessment for the anti-tumour activity of each therapy.
  • Best percentage change in tumour size using modified RECIST 1.1 assessment for the anti-tumour activity of each therapy
  • Duration of response (DoR) using modified RECIST 1.1 assessment for the anti-tumour activity of each therapy.
  • Progression free survival (PFS) using modified 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society