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NCT03381274Active, not recruitingPhase 1/2

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

A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC

Source: ClinicalTrials.gov · Last updated 23 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
43 (actual)
First submitted
18 Dec 2017
Start date
8 May 2018
Primary completion date
24 May 2021
Lead sponsor
MedImmune LLC
Diseases
Lung cancer
NCT number
NCT03381274

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 43
  • From 8 May 2018 to the primary completion date, 24 May 2021
  • 11 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior 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. Participants 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.
  • Participants 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
  • 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 cytochrome P (CYP) 3A4
  • Herbal preparations/medications are not allowed throughout the study
  • History of seizures excluding those that occurred due to previously untreated CNS metastasis

Other illness

  • Participants with a history of venous thrombosis within the past 3 months
  • Other invasive malignancy within 2 years
  • Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
  • Participants has a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD

Lab values

  • Receipt of an EGFR TKI within 14 days of the first dose of study treatment

Other

  • Participants requires continuous supplemental oxygen for any reason
    • Additional Exclusion Criteria for Arm B

Who the study is looking for

  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Weight ≥ 35 kg
  • Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFRm
    • For Arm A (Oleclumab + Osimertinib arms): must have received 1 prior line of therapy with an EGFR tyrosine kinase inhibitor (TKI) and confirmed T790M negative
    • For Arm B (Oleclumab + AZD4635 arms): must have received at least 2 but not more than 4 prior lines of therapy.

Age in the registry: 18 years to 101 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
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TaichungTaiwanUnknown status
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AtlantaUnited StatesUnknown status
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AuroraUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
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Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
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Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
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Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.