Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study

Status: Active


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


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


University of Colorado Hospital
Status: Active
Name Not Available


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


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


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


M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type


Lead Organization

Lead Organization
MedImmune Inc

Trial IDs

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