Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study
Official Title
A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 8, 2018Actual
Primary Completion Date
May 24, 2021Actual
Completion Date
Apr 16, 2026Estimated
First Submitted Date
Dec 18, 2017
First Submission Date that Met QC Criteria
Dec 18, 2017
First Posted Date
Dec 21, 2017Actual
Results Waived
Not provided
Results First Submitted Date
May 23, 2022
Results First Submitted that Met QC Criteria
Jul 25, 2022
Results First Posted Date
Jul 26, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 9, 2026
Last Update Posted Date
Mar 11, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Carcinoma, Non-Small-Cell Lung
Keywords
EGFR mutated
CD73
A2AR
Oleclumab
MEDI9447
AZD4635
Osimertinib
NSCLC
Immunotherapy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
43Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Oleclumab Dose 1 + Osimertinib Dose 1
Experimental
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).
Biological: Oleclumab
Drug: Osimertinib
Oleclumab Dose 2 + Osimertinib Dose 1
Experimental
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.
Biological: Oleclumab
Drug: Osimertinib
Oleclumab Dose 1 + AZD4635 Dose 1
Experimental
In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
Biological: Oleclumab
Drug: AZD4635
Oleclumab Dose 1 + AZD4635 Dose 2
Experimental
In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
Biological: Oleclumab
Drug: AZD4635
Oleclumab Dose 2 + AZD4635 Dose 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Oleclumab
Biological
Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.
Oleclumab Dose 1 + AZD4635 Dose 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1
A DLT was defined as >= Grade 3 toxicity or adverse events (AE) occurred during DLT evaluation period which included any Grade 4 immune-mediated (immune nature) AE, anemia, thrombocytopenia (present > 4 days), or neutropenia (present > 4 days); >= Grade 3 colitis or pneumonitis or interstitial lung disease (ILD); >= Grade 3 nausea, vomiting, or diarrhea (not resolved to <= Grade 2 in 3 days); Grade 2 pneumonitis or ILD (not resolved to <= Grade 1 in 3 days); Grade 3 thrombocytopenia with bleeding, any grade febrile neutropenia; convulsions, seizures, or stroke; protocol defined elevations of isolated liver transaminase, isolated total bilirubin (TBL), or Hy's Law; confirmed QT interval corrected for heart rate by Fridericia's formula prolongation (>= 501 msec) on triplicate electrocardiograms within a short period of time; or any other toxicity greater than that at baseline, was clinically significant and/or unacceptable, and was judged to be a DLT by the Dose Escalation Committee.
From Day 1 to Day 28 after first dose of study drug
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Parts 1 and 2
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2
Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology, clinical chemistry, thyroid function tests, and urinalysis.
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DoR) Per RECIST v 1.1 for Parts 1 and 2
The DoR is defined as duration from the first documentation of OR (confirmed CR or PR) to the first documented disease progression based on RECIST v1.1 guidelines or death due to any cause, whichever occurs first. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. The progressive disease is defined at least a 20% increase in sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The DoR was analyzed using Kaplan-Meier method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
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:
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
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.
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.
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.
The results data are reported per the primary completion date. There will be no updated results for all outcome measures at the time of end of study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
FG001
Oleclumab Dose 2 + Osimertinib Dose 1
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 1, 2021
Jul 25, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Biological: Oleclumab
Drug: AZD4635
Oleclumab Dose 1 + AZD4635 Dose 2
Oleclumab Dose 1 + Osimertinib Dose 1
Oleclumab Dose 2 + AZD4635 Dose 2
Oleclumab Dose 2 + Osimertinib Dose 1
MEDI9447
Osimertinib
Drug
Participants will receive osimertinib in combination with oleclumab as stated in the arms' description.
Oleclumab Dose 1 + Osimertinib Dose 1
Oleclumab Dose 2 + Osimertinib Dose 1
Tagrisso®
AZD4635
Drug
Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description.
Oleclumab Dose 1 + AZD4635 Dose 1
Oleclumab Dose 1 + AZD4635 Dose 2
Oleclumab Dose 2 + AZD4635 Dose 2
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2
Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) and physical examination reported as TEAEs are reported.
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Number of Participants With Notable QTc Interval in Parts 1 and 2
Notable QTc intervals included single beat changes from baseline (Day 1) values (> 30, > 60, and > 90 milliseconds). Participants who had notable QTc interval are reported.
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2
The OR is defined as confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Percentage of Participants With Disease Control (DC) in Parts 1 and 2
The DC is defined as percentage of participants with CR, PR, or stable disease (SD, which was maintained by >= 8 week) based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and non-progressive disease and not evaluable or no non-target lesion.
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Progression Free Survival (PFS) for Parts 1 and 2
The PFS is defined as the time from the start of study treatment until the documentation of disease progression based on RECIST version 1.1 or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who were alive and progression-free at the time of data cut-off for analysis had PFS censored at the last tumor assessment date. The PFS was estimated using Kaplan-Meier method.
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Overall Survival (OS) for Parts 1 and 2
The OS is defined as the time from the start of study treatment until death due to any cause. Participants who are alive at the time of data cut-off had OS censored at the last known to be alive date. The OS was estimated using Kaplan-Meier method.
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Percentage of Participants With OR by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2
The T790M status was determined by plasma testing in a central laboratory at Baseline (Days -28 to -1). The OR is defined as confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. Cell-free circulating tumor deoxyribonucleic acid (ctDNA) from liquid biopsy was used as a surrogate marker for T790M status in tumor tissue.
From Baseline (Days -28 to -1) through 90 days of the last dose of study drug (approximately 37 months)
Percentage of Participants With DC by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2
The T790M status was determined by plasma testing in a central laboratory at Baseline (Days -28 to -1). The DC is defined as percentage of participants with CR, PR, or SD (maintained by >= 8 week) based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s). Cell-free circulating tumor deoxyribonucleic acid (ctDNA) from liquid biopsy was used as a surrogate marker for T790M status in tumor tissue.
From Baseline (Days -28 to -1) through 90 days of the last dose of study drug (approximately 37 months)
Observed Serum Concentration at the Time of End of Infusion (CEOI) of Oleclumab (MEDI9447) Over Time
The CEOI of oleclumab is reported.
Predose (within 90 minutes prior to start of infusion) and postdose (10 minutes after the end of infusion) on Days 1 and 57
Observed Lowest Serum Concentration (Ctrough) of MEDI9447 Over Time
The Ctrough of oleclumab is reported.
Predose (within 90 minutes prior to start of infusion) on Day 57
Maximum Plasma Concentration (Cmax) of Osimertinib and Its Metabolite (AZ5104)
The Cmax of osimertinib and AZ5104 are reported.
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, and 4 hours) on Days 1 and 29
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)
The Cmax of AZD4635, SSP-005173X, and SSP-005174X are reported.
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)
The Tmax of AZD4635, SSP-005173X, and SSP-005174X are reported.
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)
The AUC0-24 of AZD4635, SSP-005173X, and SSP-005174X are reported.
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57
Number of Participants With Positive Post-baseline for Anti-oleclumab Antibodies
Number of participants with positive post-baseline for anti-oleclumab antibodies are reported.
Predose on Days 1 (Baseline), 29, and 57, and later every 12 weeks through the 12 months and 90 days after the last dose of study drug (approximately 37 months)
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
FG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
FG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
FG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
FG0005 subjects
FG00121 subjects
FG0026 subjects
FG0036 subjects
FG0045 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0005 subjects
FG00121 subjects
FG0026 subjects
FG0036 subjects
FG0045 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0019 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG004
Other
FG0001 subjects
FG00111 subjects
FG0020 subjects
FG0032 subjects
FG004
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
BG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
BG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
BG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
BG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG00121
BG0026
BG0036
BG0045
BG00543
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00061.2± 2.9
BG00161.4± 10.3
BG00264.5± 10.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG00110
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1
A DLT was defined as >= Grade 3 toxicity or adverse events (AE) occurred during DLT evaluation period which included any Grade 4 immune-mediated (immune nature) AE, anemia, thrombocytopenia (present > 4 days), or neutropenia (present > 4 days); >= Grade 3 colitis or pneumonitis or interstitial lung disease (ILD); >= Grade 3 nausea, vomiting, or diarrhea (not resolved to <= Grade 2 in 3 days); Grade 2 pneumonitis or ILD (not resolved to <= Grade 1 in 3 days); Grade 3 thrombocytopenia with bleeding, any grade febrile neutropenia; convulsions, seizures, or stroke; protocol defined elevations of isolated liver transaminase, isolated total bilirubin (TBL), or Hy's Law; confirmed QT interval corrected for heart rate by Fridericia's formula prolongation (>= 501 msec) on triplicate electrocardiograms within a short period of time; or any other toxicity greater than that at baseline, was clinically significant and/or unacceptable, and was judged to be a DLT by the Dose Escalation Committee.
The DLT-evaluable population included all participants who enrolled in the dose-escalation phase, received all planned doses of oleclumab and at least 75% of the daily administrations of osimertinib or AZD4635 during the DLT-evaluation period and completed the safety follow-up through the DLT-evaluation period or experienced any DLTs.
Posted
Count of Participants
Participants
From Day 1 to Day 28 after first dose of study drug
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Parts 1 and 2
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Primary
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2
Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology, clinical chemistry, thyroid function tests, and urinalysis.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
Primary
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2
Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) and physical examination reported as TEAEs are reported.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
Primary
Number of Participants With Notable QTc Interval in Parts 1 and 2
Notable QTc intervals included single beat changes from baseline (Day 1) values (> 30, > 60, and > 90 milliseconds). Participants who had notable QTc interval are reported.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
Primary
Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2
The OR is defined as confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Secondary
Duration of Response (DoR) Per RECIST v 1.1 for Parts 1 and 2
The DoR is defined as duration from the first documentation of OR (confirmed CR or PR) to the first documented disease progression based on RECIST v1.1 guidelines or death due to any cause, whichever occurs first. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. The progressive disease is defined at least a 20% increase in sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The DoR was analyzed using Kaplan-Meier method.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. The DoR was analyzed for participants who achieved OR.
Posted
Median
95% Confidence Interval
Months
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Secondary
Percentage of Participants With Disease Control (DC) in Parts 1 and 2
The DC is defined as percentage of participants with CR, PR, or stable disease (SD, which was maintained by >= 8 week) based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and non-progressive disease and not evaluable or no non-target lesion.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Secondary
Progression Free Survival (PFS) for Parts 1 and 2
The PFS is defined as the time from the start of study treatment until the documentation of disease progression based on RECIST version 1.1 or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who were alive and progression-free at the time of data cut-off for analysis had PFS censored at the last tumor assessment date. The PFS was estimated using Kaplan-Meier method.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Median
95% Confidence Interval
Months
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Secondary
Overall Survival (OS) for Parts 1 and 2
The OS is defined as the time from the start of study treatment until death due to any cause. Participants who are alive at the time of data cut-off had OS censored at the last known to be alive date. The OS was estimated using Kaplan-Meier method.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Median
95% Confidence Interval
Months
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
Secondary
Percentage of Participants With OR by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2
The T790M status was determined by plasma testing in a central laboratory at Baseline (Days -28 to -1). The OR is defined as confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. Cell-free circulating tumor deoxyribonucleic acid (ctDNA) from liquid biopsy was used as a surrogate marker for T790M status in tumor tissue.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. 'Number of participants analyzed' denotes participants who had T790M status positive or negative at baseline (Days -28 to -1). The T790M status results was assessed only for participants in 'Oleclumab + Osimertinib' arms.
Posted
Number
95% Confidence Interval
Percentage of participants
From Baseline (Days -28 to -1) through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Secondary
Percentage of Participants With DC by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2
The T790M status was determined by plasma testing in a central laboratory at Baseline (Days -28 to -1). The DC is defined as percentage of participants with CR, PR, or SD (maintained by >= 8 week) based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline, and non-progressive disease and not evaluable or no non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s). Cell-free circulating tumor deoxyribonucleic acid (ctDNA) from liquid biopsy was used as a surrogate marker for T790M status in tumor tissue.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. 'Number of participants analyzed' denotes participants who had T790M status positive or negative at baseline (Days -28 to -1).
Posted
Number
95% Confidence Interval
Percentage of participants
From Baseline (Days -28 to -1) through 90 days of the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Secondary
Observed Serum Concentration at the Time of End of Infusion (CEOI) of Oleclumab (MEDI9447) Over Time
The CEOI of oleclumab is reported.
Pharmacokinetic (PK) population included all participants who received any study drug, analyzed according to the treatment they actually received, and had at least one quantifiable post-dose concentration with no important protocol deviations or AEs considered to impact the PK data. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose (within 90 minutes prior to start of infusion) and postdose (10 minutes after the end of infusion) on Days 1 and 57
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Secondary
Observed Lowest Serum Concentration (Ctrough) of MEDI9447 Over Time
The Ctrough of oleclumab is reported.
The PK population included all participants who received any study drug, analyzed according to the treatment they actually received, and had at least one quantifiable post-dose concentration with no important protocol deviations or AEs considered to impact the PK data. ''Number of participants analyzed' denotes the number of participants who had adequate PK sample and were evaluated for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose (within 90 minutes prior to start of infusion) on Day 57
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Secondary
Maximum Plasma Concentration (Cmax) of Osimertinib and Its Metabolite (AZ5104)
The Cmax of osimertinib and AZ5104 are reported.
The PK population included all participants who received any study drug, analyzed according to the treatment they actually received, and had at least one quantifiable post-dose concentration with no important protocol deviations or AEs considered to impact the PK data. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, and 4 hours) on Days 1 and 29
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Secondary
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)
The Cmax of AZD4635, SSP-005173X, and SSP-005174X are reported.
The PK population included all participants who received any study drug, analyzed according to the treatment they actually received, and had at least one quantifiable post-dose concentration with no important protocol deviations or AEs considered to impact the PK data. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57
ID
Title
Description
OG000
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG001
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG002
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Secondary
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)
The Tmax of AZD4635, SSP-005173X, and SSP-005174X are reported.
The PK population included all participants who received any study drug, analyzed according to the treatment they actually received, and had at least one quantifiable post-dose concentration with no important protocol deviations or AEs considered to impact the PK data. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
Hour
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57
ID
Title
Description
OG000
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG001
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG002
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X)
The AUC0-24 of AZD4635, SSP-005173X, and SSP-005174X are reported.
The PK population included all participants who received any study drug, analyzed according to the treatment they actually received, and had at least one quantifiable post-dose concentration with no important protocol deviations or AEs considered to impact the PK data. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57
ID
Title
Description
OG000
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG001
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG002
Oleclumab Dose 2 + AZD4635 Dose 2
Secondary
Number of Participants With Positive Post-baseline for Anti-oleclumab Antibodies
Number of participants with positive post-baseline for anti-oleclumab antibodies are reported.
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Predose on Days 1 (Baseline), 29, and 57, and later every 12 weeks through the 12 months and 90 days after the last dose of study drug (approximately 37 months)
ID
Title
Description
OG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
Time Frame
From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Oleclumab Dose 1 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
2
5
3
5
5
5
EG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
9
21
6
21
21
21
EG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
3
6
4
6
6
6
EG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
2
6
1
6
5
6
EG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
3
5
3
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected5 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected5 at risk
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG00111 events5 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0017 events4 affected21 at risk
EG0026 events4 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0016 events6 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0014 events1 affected21 at risk
EG0026 events5 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Face oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0014 events4 affected21 at risk
EG0022 events2 affected6 at risk
EG003
Localised oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Paronychia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected5 at risk
EG0017 events6 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events3 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events2 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events3 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0005 events1 affected5 at risk
EG0017 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0015 events4 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0005 events1 affected5 at risk
EG0012 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0023 events1 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0003 events1 affected5 at risk
EG0012 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0012 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0003 events1 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events3 affected21 at risk
EG0022 events2 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Visual brightness
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events2 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0013 events3 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0015 events3 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0018 events7 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected5 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected6 at risk
EG003
Arm B (Oleclumab + AZD4635 groups) did not proceed to the dose expansion phase due to lack of response to treatment and a change in the formulation of AZD4635. The OR and DC by T790M status for 'Oleclumab + AZD4635' groups were not conducted due to the small sample size.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG0005
OG00121
OG0026
OG0035
OG0045
Any TESAEs
Title
Measurements
OG0003
OG0016
OG0024
OG003
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0002
OG0010
OG0021
OG0031
OG0040
Neutropenia
Title
Measurements
OG0001
OG0011
OG0020
OG003
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0012
OG0020
OG003
Amylase increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0013
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0000
OG0012
OG0020
OG003
Blood creatinine increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Lipase increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hypercholesterolaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyperglycaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyperkalaemia
Title
Measurements
OG0001
OG0011
OG0020
OG003
Hypoalbuminaemia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hypocalcaemia
Title
Measurements
OG0001
OG0011
OG0020
OG003
Hypokalaemia
Title
Measurements
OG0001
OG0011
OG0020
OG003
Hypomagnesaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyponatraemia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Hypophosphataemia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Leukopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood albumin decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemoglobin decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Neutrophil count decreased
Title
Measurements
OG0000
OG0012
OG0020
OG003
White blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypercalcaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Thrombocytopenia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypothyroidism
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood creatine phosphokinase increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Platelet count decreased
Title
Measurements
OG0000
OG0012
OG0020
OG003
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Hypertension
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
Hypotension
Title
Measurements
OG0001
OG0010
OG0020
OG003
Pyrexia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypoxia
Title
Measurements
OG0000
OG0010
OG0021
OG003
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Single Beat change from baseline, Change > 30 milliseconds
Title
Measurements
OG0002
OG0016
OG0022
OG0032
OG0041
Single Beat change from baseline, Change > 60 milliseconds
Title
Measurements
OG0000
OG0012
OG0020
OG003
Single Beat change from baseline, Change > 90 milliseconds
Title
Measurements
OG0000
OG0010
OG0020
OG003
Units
Counts
Participants
OG00021
Title
Denominators
Categories
Title
Measurements
OG00019(5.4 to 41.9)
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0002
OG0014
OG0020
OG0030
OG0040
Title
Denominators
Categories
Title
Measurements
OG00011.4(4.8 to 18.1)
OG001NA(9.2 to NA)Median and upper limit of 95% confidence interval (CI) were not derived due to insufficient events being observed at the time of the analysis.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Title
Measurements
OG00080.0(28.4 to 99.5)
OG00181.0(58.1 to 94.6)
OG0020(NA to NA)95% CI was not derived due to insufficient events being observed at the time of the analysis.
OG00316.7(0.4 to 64.1)
OG0040(NA to NA)95% CI was not derived due to insufficient events being observed at the time of the analysis.
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Title
Measurements
OG0006.5(1.4 to 19.8)
OG00111.0(3.7 to NA)Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.
OG0021.4(0.5 to 1.8)
OG0031.8(0.8 to 5.5)
OG0041.9(1.4 to 2.3)
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Title
Measurements
OG00021.9(1.4 to NA)Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.
OG00124.8(12.3 to NA)Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.
OG00216.4(1.0 to 16.4)
OG00327.4(1.5 to NA)Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.
OG0047.1(1.9 to NA)Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
OR by T790M status positive
ParticipantsOG0001
ParticipantsOG0013
Title
Measurements
OG000100(2.5 to 100)
OG00166.7(9.4 to 99.2)
OR by T790M status negative
ParticipantsOG0004
ParticipantsOG00117
Title
Measurements
OG00025.0(0.6 to 80.6)
OG001
OG001
Oleclumab Dose 2 + Osimertinib Dose 1
In Part 1 (dose-escalation), participants received 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) received 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 occurred first.
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
DC by T790M status positive
ParticipantsOG0001
ParticipantsOG0013
Title
Measurements
OG000100(2.5 to 100)
OG001100(29.2 to 100)
DC by T790M status negative
ParticipantsOG0004
ParticipantsOG00117
Title
Measurements
OG00075.0(19.4 to 99.4)
OG001
OG002
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0025
OG0036
OG0043
Title
Denominators
Categories
Day 1
ParticipantsOG0005
ParticipantsOG00121
ParticipantsOG0025
ParticipantsOG0036
ParticipantsOG0043
Title
Measurements
OG000545.7± 22.29
OG001787.6± 31.27
OG002494.6± 23.69
OG003
Day 57
ParticipantsOG0003
ParticipantsOG00116
ParticipantsOG0020
ParticipantsOG0031
Oleclumab Dose 1 + AZD4635 Dose 1
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0003
OG00118
OG0020
OG0032
OG0042
Title
Denominators
Categories
Title
Measurements
OG000271.5± 38.03
OG001315.5± 35.42
OG003NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
OG004NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
Units
Counts
Participants
OG0005
OG00121
Title
Denominators
Categories
Osimertinib, Day 1
ParticipantsOG0004
ParticipantsOG00120
Title
Measurements
OG000151.9± 18.73
OG001130.5± 92.63
Osimertinib, Day 29
ParticipantsOG0003
ParticipantsOG00120
Title
Measurements
OG000529.9± 28.46
OG001
AZ5104, Day 1
ParticipantsOG0004
ParticipantsOG00119
Title
Measurements
OG0003.271± 60.73
OG001
AZ5104, Day 29
ParticipantsOG0003
ParticipantsOG00120
Title
Measurements
OG00052.06± 43.62
OG001
Units
Counts
Participants
OG0006
OG0016
OG0023
Title
Denominators
Categories
AZD4635, Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0023
Title
Measurements
OG000548.2± 19.57
OG001330.6± 34.02
OG002319.5± 17.93
AZD4635, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
SSP-005173X, Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0023
Title
Measurements
OG000
SSP-005173X, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
SSP-005174X, Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0023
Title
Measurements
OG000
SSP-005174X, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
Units
Counts
Participants
OG0006
OG0016
OG0023
Title
Denominators
Categories
AZD4635, Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0023
Title
Measurements
OG0001.03(1.00 to 2.13)
OG0011.07(1.00 to 1.08)
OG0021.05(1.02 to 1.22)
AZD4635, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
SSP-005173X, Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0023
Title
Measurements
OG000
SSP-005173X, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
SSP-005174X, Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0023
Title
Measurements
OG000
SSP-005174X, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0006
OG0016
OG0023
Title
Denominators
Categories
AZD4635, Day 1
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
Title
Measurements
OG0002546± 27.24
OG0011324± 28.02
OG0021624± 20.32
AZD4635, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
SSP-005173X, Day 1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0023
Title
Measurements
OG000
SSP-005173X, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
SSP-005174X, Day 1
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0023
Title
Measurements
OG000
SSP-005174X, Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
Title
Measurements
OG001
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
OG003
Oleclumab Dose 1 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
OG004
Oleclumab Dose 2 + AZD4635 Dose 2
In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Units
Counts
Participants
OG0005
OG00121
OG0026
OG0036
OG0045
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
3 events
3 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
3 events
3 affected
6 at risk
EG0043 events2 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected5 at risk
3 events
3 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
2 events
2 affected
6 at risk
EG0042 events2 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0042 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected5 at risk
1
OG0043
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
1
OG0041
0
OG0040
0
OG0040
0
OG0040
0
OG0040
1
OG0040
0
OG0041
0
OG0040
1
OG0040
1
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0041
0
OG0040
0
OG0040
11.8
(1.5 to 36.4)
82.4
(56.6 to 96.2)
385.4
± 23.51
OG004633.3± 33.45
Participants
OG004
2
Title
Measurements
OG000926.4± 15.55
OG0011183± 24.76
OG003NA± NAGeometric mean and geometric coefficient of variation (CV) were not derived due to insufficient observations (n\<3) at the specified time point.
OG004NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
484.9
± 48.69
3.954
± 72.97
45.30
± 53.84
NA
± NA
Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA± NAGeometric mean and geometric CV were no derived due to insufficient observations (n\<3) at the specified time point.
9.238
± 62.78
OG00112.54± 52.36
OG0026.747± 66.91
NA
± NA
Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
67.78
± 30.28
OG00158.18± 54.66
OG00240.60± 32.19
NA
± NA
Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
NA
(NA to 2.13)
Median and upper limit of range were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA(0.917 to 1.00)Median was not derived due to insufficient observations (n\<3) at the specified time point.
1.54
(1.00 to 2.13)
OG0011.93(1.02 to 2.03)
OG0021.22(1.02 to 2.07)
NA
(NA to 2.13)
Median and lower limit of range were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA(0.917 to 1.00)Median was not derived due to insufficient observations (n\<3) at the specified time point.
1.03
(1.00 to 2.13)
OG0011.07(1.00 to 1.87)
OG0021.05(1.02 to 1.22)
NA
(NA to 2.13)
Median and lower limit of range were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA(NA to 1.00)Median and lower limit of range were not derived due to insufficient observations (n\<3) at the specified time point.
NA
± NA
Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
84.08
± 94.72
OG00176.57± 68.17
OG00259.88± 61.87
NA
± NA
Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
304.4
± 54.74
OG001231.9± 65.94
OG002192.4± 24.54
NA
± NA
Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.
OG002NA± NAGeometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.