Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study

Part of paid clinical trials in La Jolla, California.

Sponsor
MedImmune LLC
Study ID
NCT03381274
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • Oleclumab — BIOLOGICAL
    Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.
  • Osimertinib — DRUG
    Participants will receive osimertinib in combination with oleclumab as stated in the arms' description.
  • AZD4635 — DRUG
    Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description.

Study Details

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

Key Dates

Start date
May 8, 2018
Status verified
Mar 2026
Primary completion
May 24, 2021
Completion
Apr 16, 2026

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oleclumab Dose 1 + Osimertinib Dose 1
    In Part 1 (dose-escalation), participants will receive intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
  • Experimental: Oleclumab Dose 2 + Osimertinib Dose 1
    In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral osimertinib Dose 1 QD. In Part 2 (dose-expansion), participants (including participants dosed at the RP2D in Part 1) will receive IV oleclumab Dose 2 Q2W and oral osimertinib Dose 1 QD until documentation of disease progression, intolerable toxicity, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Oleclumab Dose 1 + AZD4635 Dose 1
    In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
  • Experimental: Oleclumab Dose 1 + AZD4635 Dose 2
    In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
  • Experimental: Oleclumab Dose 2 + AZD4635 Dose 2
    In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1 [ Time Frame: From Day 1 to Day 28 after first dose of study drug ]

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteSan FranciscoCalifornia94143-
Research SiteAuroraColorado80045-
Research SiteNew HavenConnecticut06510-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60611-
Research SiteBaltimoreMaryland21224-
Research SiteNew YorkNew York10032-
Research SiteHoustonTexas77030-

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