Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study

Status: Active

Description

The objective of this study is to investigate the safety, tolerability and antitumor activity of novel combination therapies administered in subjects with advanced EGFRm NSCLC

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18
  • ECOG Performance Status of 0 or 1
  • Weight ≥ 35 kg
  • Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFR mutation
  • For Arm A: must have received 1 prior line of therapy with an EGFR TKI and confirmed T790M negative
  • For Arm B: must have received at least 2 but not more than 4 prior lines of therapy.

Exclusion Criteria

  • Receipt of an EGFR TKI within 14 days of the first dose of study treatment.
  • Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose.
  • Prior receipt of any investigational immunotherapy. Subjects may have received agents that have local health authority approval for the disease indication
  • Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
  • Subjects with a history of venous thrombosis within the past 3 months
  • Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months
  • Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
  • Other invasive malignancy within 2 years.
  • Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose Additional Exclusion Criteria for Arm A
  • Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of CYP3A4
  • Subject has a history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
  • Subject requires continuous supplemental oxygen for any reason. Additional Exclusion Criteria for Arm B
  • Herbal preparations/medications are not allowed throughout the study
  • History of seizures excluding those that occurred due to previously untreated CNS metastasis

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Temporarily closed to accrual
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Maryland

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

New York

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

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
MedImmune Inc

Trial IDs

Primary ID D6070C00004
Secondary IDs NCI-2018-00476
Clinicaltrials.gov ID NCT03381274