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

NCT ID: NCT03381274

Last Updated: 2025-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-08

Study Completion Date

2026-04-16

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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EGFR mutated CD73 A2AR Oleclumab MEDI9447 AZD4635 Osimertinib NSCLC Immunotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Oleclumab

Intervention Type BIOLOGICAL

Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.

Osimertinib

Intervention Type DRUG

Participants will receive osimertinib in combination with oleclumab as stated in the arms' description.

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.

Group Type EXPERIMENTAL

Oleclumab

Intervention Type BIOLOGICAL

Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.

Osimertinib

Intervention Type DRUG

Participants will receive osimertinib in combination with oleclumab as stated in the arms' description.

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.

Group Type EXPERIMENTAL

Oleclumab

Intervention Type BIOLOGICAL

Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.

AZD4635

Intervention Type DRUG

Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description.

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.

Group Type EXPERIMENTAL

Oleclumab

Intervention Type BIOLOGICAL

Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.

AZD4635

Intervention Type DRUG

Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description.

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.

Group Type EXPERIMENTAL

Oleclumab

Intervention Type BIOLOGICAL

Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.

AZD4635

Intervention Type DRUG

Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description.

Interventions

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Oleclumab

Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.

Intervention Type BIOLOGICAL

Osimertinib

Participants will receive osimertinib in combination with oleclumab as stated in the arms' description.

Intervention Type DRUG

AZD4635

Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description.

Intervention Type DRUG

Other Intervention Names

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MEDI9447 Tagrisso®

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Weight ≥ 35 kg
4. 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.

Exclusion Criteria

1. Receipt of an EGFR TKI within 14 days of the first dose of study treatment
2. Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose
3. Prior receipt of any investigational immunotherapy. Participants may have received agents that have local health authority approval for the disease indication
4. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.
5. Participants with a history of venous thrombosis within the past 3 months
6. Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months
7. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
8. Other invasive malignancy within 2 years
9. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose


1. Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of cytochrome P (CYP) 3A4
2. 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
3. Participants requires continuous supplemental oxygen for any reason


1. Herbal preparations/medications are not allowed throughout the study
2. History of seizures excluding those that occurred due to previously untreated CNS metastasis
Minimum Eligible Age

18 Years

Maximum Eligible Age

101 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MedImmune LLC

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Research Site

La Jolla, California, United States

Site Status

Research Site

San Francisco, California, United States

Site Status

Research Site

Aurora, Colorado, United States

Site Status

Research Site

New Haven, Connecticut, United States

Site Status

Research Site

Atlanta, Georgia, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Taichung, , Taiwan

Site Status

Countries

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United States South Korea Taiwan

References

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Kim DW, Kim SW, Camidge DR, Shu CA, Marrone KA, Le X, Blakely CM, Park K, Chang GC, Patel SP, Kar G, Cooper ZA, Samadani R, Pluta M, Kumar R, Ramalingam S. CD73 Inhibitor Oleclumab Plus Osimertinib in Previously Treated Patients With Advanced T790M-Negative EGFR-Mutated NSCLC: A Brief Report. J Thorac Oncol. 2023 May;18(5):650-656. doi: 10.1016/j.jtho.2022.12.021. Epub 2023 Jan 11.

Reference Type DERIVED
PMID: 36641093 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6070C00004&attachmentIdentifier=f05a0e14-fcde-4156-bdf4-8f6c64c7e249&fileName=protocol-d6070c00004-amendment-4-Redacted_18May2022.pdf&versionIdentifier=

D6070C00004 redacted protocol

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6070C00004&attachmentIdentifier=3142be22-09f6-4179-9790-abf963256362&fileName=d6070c00004-sap-ed-1-Redacted_18May2022.pdf&versionIdentifier=

D6070C00004 SAP redacted

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6070C00004&attachmentIdentifier=ffb0494a-509e-4883-9486-10075daf7ef7&fileName=d6070c00004-study-synopsis-Redacted_18May2022.pdf&versionIdentifier=

D6070C00004 CSR Synopsis redacted

Other Identifiers

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D6070C00004

Identifier Type: -

Identifier Source: org_study_id