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

NCT03334617

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Non-Small Cell Lung Cancer

Interventions: Durvalumab, Danvatirsen, Ceralasertib, Vistusertib, Olaparib

Countries: United States, Austria, Canada, France, Germany, Israel, South Korea, Spain

This is an open-label, multi-centre, umbrella Phase II study in participants 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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* At least 18 years of age at the time of signing the informed consent form.
* Participant must have histologically or cytologically confirmed metastatic or locally advanced and recurrent non-small-cell lung cancer (NSCLC) which is progressing.
* Participants eligible for second- or later-line therapy, who must have received an anti-programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (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 participant must have had disease progression on a prior line of anti-PD-1/PD-L1 therapy.
* Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
* Participant 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 participants.

Exclusion Criteria:

* Participants whose tumour samples have targetable alterations in epidermal growth factor receptor (EGFR) and/or anaplastic lymphoma kinase (ALK) at initial diagnosis are excluded. In addition, participants 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 tuberculosis, hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies).
* Female participant who are pregnant or breastfeeding, or male or female participants 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, or history of severe hypersensitivity reactions to other monoclonal antibodies.
* Participant has spinal cord compression or symptomatic brain metastases.
* Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Participants may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases.
* History of active primary immunodeficiency.
Locations (45)
  • Duarte, California, United States
  • Fullerton, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Washington D.C., District of Columbia, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Fairfax, Virginia, United States
  • Innsbruck, Austria
  • Salzburg, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Edmonton, Alberta, Canada
  • Brampton, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Bordeaux, France
  • Nantes, France
  • Paris, France
  • Villejuif, France
  • + 15 more on CT.gov