Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study
United States, South Korea, Taiwan43 participantsStarted 2018-05-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 101 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
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. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1
Timeframe: From Day 1 to Day 28 after first dose of study drug
2
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Parts 1 and 2
Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
3
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2
Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
4
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2
Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
5
Number of Participants With Notable QTc Interval in Parts 1 and 2
Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
6
Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2