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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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 facts

Study ID

NCT03381274

Run by

MedImmune LLC

People needed

43

Starts

2018-05-08

Expected to finish

2026-11-06

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 101. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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. 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 a history of venous thrombosis within the past 3 months
• 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
• Other invasive malignancy within 2 years
• Untreated central nervous system (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 cytochrome P (CYP) 3A4
• 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
• Participants 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

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — New York, New York, United States
• Research Site — Houston, Texas, United States
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Taichung, Taiwan

Full record on ClinicalTrials.gov

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