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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age at the time of signing the informed consent form.
  • Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing.
  • Patients eligible for second- or later-line therapy, who must have received an antiPD1/PD-L1 containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The patient must have had disease progression on a prior line of antiPD1/PD-L1 therapy.
  • ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
  • Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed.
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Exclusion Criteria

  • Patients whose tumour samples have targetable alterations in EGFR and/or ALK are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Active infection including hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
  • Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Patient has spinal cord compression or symptomatic brain metastases.
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Patients may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases.

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Lia Etheridge
Phone: 310-825-7174
Email: LEtheridge@mednet.ucla.edu
San Diego
University of California San Diego
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
AstraZeneca Pharmaceuticals LP

Trial IDs

Primary ID D6185C00001
Secondary IDs NCI-2018-00569, 2017-002208-28, 119833, 138050
Clinicaltrials.gov ID NCT03334617