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A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

Trial Status: Active

This study is designed to determine the efficacy and safety of durvalumab and / or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

  • Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
  • No prior chemotherapy or any other systemic therapy for metastatic NSCLC
  • Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred >12 months from end of last therapy
  • Known tumor PD-L1 status
  • WHO/ECOG status at 0 or 1 at enrollment
  • Life expectancy of at least 12 weeks
  • Troponin I or T ≤ ULN (per institutional guidelines)

Exclusion Criteria

  • Active or prior documented autoimmune or inflammatory disorders
  • History of active primary immunodeficiency
  • Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
  • Untreated CNS metastases

California

San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: WITHDRAWN

This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of

Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line

Stage IV Non-Small Cell Lung Cancer (NSCLC).

Trial Phase Phase I

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D933IC00001
  • Secondary IDs NCI-2019-01198, 2018-001748-74
  • Clinicaltrials.gov ID NCT03819465