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

Status: Active

Description

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies and with or without chemotherapy, for first-line Stage IV non small cell lung cancer (NSCLC)

Eligibility Criteria

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

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

Locations & Contacts

California

San Diego
University of California San Diego
Status: Active
Name Not Available

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Objectives and Outline

This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab in Combination With Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non Small Cell Lung Cancer (NSCLC).

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
AstraZeneca Pharmaceuticals LP

Trial IDs

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