Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03381274 |
Recruitment Status :
Active, not recruiting
First Posted : December 21, 2017
Last Update Posted : May 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung | Biological: MEDI9447 Drug: Osimertinib Drug: AZD4635 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC |
Actual Study Start Date : | May 8, 2018 |
Actual Primary Completion Date : | May 24, 2021 |
Estimated Study Completion Date : | May 24, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
MEDI9447 and osimertinib
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Biological: MEDI9447
Subjects will receive MEDI9447 in combination with osimertinib or AZD4635 until disease progression Drug: Osimertinib Subjects will receive osimertinib in combination with MEDI9447 until disease progression |
Experimental: Arm B
MEDI9447 and AZD4635
|
Biological: MEDI9447
Subjects will receive MEDI9447 in combination with osimertinib or AZD4635 until disease progression Drug: AZD4635 Subjects will receive AZD4635 in combination with MEDI9447 until disease progression |
- Incidence of Adverse Events as a measure of safety [ Time Frame: Screening through 90 days after last dose of investigational product ]The primary endpoint is safety as assessed by the presence of adverse events and serious adverse events
- Objective response rate as a measure of anti tumor activity in dose expansion phase [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]The primary endpoint in dose expansion phase includes efficacy assessed by objective response
- Duration of Response (DoR) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]The duration from the first documentation of objective response (OR) to the first documented disease progression or death due to any cause, whichever occurs first
- Disease Control (DC) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]Defined as complete response (CR), partial response (PR) or stable disease (SD)
- Progression Free Survival (PFS) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]From the start of treatment with investigational product until the first documentation of disease progression or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]From the start of treatment with investigational product until death due to any cause
- Objective Response by T790M status [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]Defined as best overall response of confirmed CR or confirmed PR according to RECIST version 1.1
- Disease Control by T790M status [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]Defined as CR, PR or SD
- Serum MEDI9447 concentration levels [ Time Frame: During treatment through 90 days after last dose of investigational product ]Pharmacokinetic
- Serum Osimertinib concentration levels [ Time Frame: During treatment through 90 days after last dose of investigational product ]Pharmacokinetic
- Serum AZD4635 concentration levels [ Time Frame: During treatment through 90 days after last dose of investigational product ]Pharmacokinetic
- Development of detectable anti-drug antibody(ADA) to MEDI9447 [ Time Frame: During treatment through 90 days after last dose of investigational product ]Immunogenicity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 101 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18
- ECOG Performance Status of 0 or 1
- Weight ≥ 35 kg
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381274
United States, California | |
Research Site | |
La Jolla, California, United States, 92093 | |
Research Site | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
Research Site | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Research Site | |
New Haven, Connecticut, United States, 06510 | |
United States, Georgia | |
Research Site | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Research Site | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Research Site | |
Baltimore, Maryland, United States, 21224 | |
United States, New York | |
Research Site | |
New York, New York, United States, 10032 | |
United States, Texas | |
Research Site | |
Houston, Texas, United States, 77030 | |
Korea, Republic of | |
Research Site | |
Seoul, Korea, Republic of, 03080 | |
Research Site | |
Seoul, Korea, Republic of, 06351 | |
Research Site | |
Seoul, Korea, Republic of, 138-736 | |
Taiwan | |
Research Site | |
Taichung, Taiwan, 40705 |
Study Director: | MedImmune LLC | MedImmune LLC |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT03381274 |
Other Study ID Numbers: |
D6070C00004 |
First Posted: | December 21, 2017 Key Record Dates |
Last Update Posted: | May 6, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
EGFR mutated, CD73, A2AR, oleclumab, MEDI9447, AZD4635, osimertinib, NSCLC, immunotherapy |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Osimertinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |