Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

Status: Active

Description

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Eligibility Criteria

Inclusion Criteria

  • Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
  • Age 18 years or older
  • Body weight ≥ 35 kg
  • Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
  • Subjects must have completed, without progressing, definitive cCRT within 28 days prior to being randomized into the study:
  • Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1

Exclusion Criteria

  • Mixed small cell and non-small cell lung cancer histology
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
  • Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
  • Subjects with a history of venous thrombosis within the past 3 months
  • Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
  • Congestive heart failure
  • Active or prior documented autoimmune or inflammatory disorders
  • History of active primary immunodeficiency
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  • History of allogenic organ transplantation
  • QTcF interval ≥ 470 ms
  • History of another primary malignancy
  • Concurrent enrollment in another therapeutic clinical study or during the follow-up period of an interventional study. Enrollment in observational studies will be allowed
  • Females who are pregnant, lactating, or intend to become pregnant during their participation in the study

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Objectives and Outline

Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
MedImmune Inc

Trial IDs

Primary ID D9108C00001
Secondary IDs NCI-2019-02118
Clinicaltrials.gov ID NCT03822351