A Phase 1/2 interventional study of Oleclumab and Osimertinib in Carcinoma, Non-Small-Cell Lung, sponsored by MedImmune LLC. Active, not recruiting at 13 sites in 3 countries. Open to participants aged 18 Years to 101 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 1/2, Interventional, and Treatment
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 43 is below the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
First submitted after MedImmune LLC became part of AstraZeneca.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with or cytologically confirmed locally advanced/ NSCLC with EGFRm
Exclusion Criteria:
Additional Exclusion Criteria for Arm A
Additional Exclusion Criteria for Arm B
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.
Biological: Oleclumab · Drug: AZD4635
In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.
Biological: Oleclumab · Drug: AZD4635
In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Biological: Oleclumab · Drug: AZD4635
Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description.
Also known as: MEDI9447
Participants will receive osimertinib in combination with oleclumab as stated in the arms' description.
Also known as: Tagrisso®
Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
| Milestone | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Started | 5 | 21 | 6 | 6 | 5 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 5 | 21 | 6 | 6 | 5 |
| Withdrew: Death | 2 | 9 | 3 | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 3 | 1 | 0 |
| Withdrew: Other | 1 | 11 | 0 | 2 | 2 |
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.
| Participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1 | 0 | 0 | 1 | 0 | 0 |
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.
| Participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Any TEAEs | 5 | 21 | 6 | 5 | 5 |
| Any TESAEs | 3 | 6 | 4 | 1 | 3 |
Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology, clinical chemistry, thyroid function tests, and urinalysis.
| Participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Anaemia | 2 | 0 | 1 | 1 | 0 |
| Neutropenia | 1 | 1 | 0 | 0 | 0 |
| Alanine aminotransferase increased | 0 | 2 | 0 | 0 | 0 |
| Amylase increased | 1 | 0 | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 0 | 3 | 0 | 0 | 0 |
| Blood alkaline phosphatase increased | 0 | 2 | 0 | 0 | 0 |
| Blood creatinine increased | 1 | 0 | 0 | 0 | 0 |
| Lipase increased | 1 | 0 | 0 | 0 | 0 |
| Hypercholesterolaemia | 0 | 1 | 0 | 0 | 0 |
| Hyperglycaemia | 0 | 1 | 0 | 0 | 0 |
| Hyperkalaemia | 1 | 1 | 0 | 0 | 0 |
| Hypoalbuminaemia | 1 | 0 | 1 | 0 | 0 |
| Hypocalcaemia | 1 | 1 | 0 | 1 | 1 |
| Hypokalaemia | 1 | 1 | 0 | 0 | 0 |
| Hypomagnesaemia | 0 | 1 | 0 | 0 | 0 |
| Hyponatraemia | 1 | 1 | 1 | 0 | 0 |
| Hypophosphataemia | 1 | 0 | 0 | 0 | 0 |
| Leukopenia | 0 | 0 | 0 | 1 | 0 |
| Blood albumin decreased | 0 | 0 | 0 | 0 | 1 |
| Haemoglobin decreased | 0 | 0 | 1 | 0 | 0 |
| Neutrophil count decreased | 0 | 2 | 0 | 1 | 0 |
| White blood cell count decreased | 0 | 0 | 0 | 1 | 0 |
| Hypercalcaemia | 0 | 0 | 1 | 0 | 0 |
| Thrombocytopenia | 0 | 1 | 0 | 0 | 0 |
| Hypothyroidism | 0 | 1 | 0 | 0 | 0 |
| Blood creatine phosphokinase increased | 0 | 1 | 0 | 0 | 0 |
| Platelet count decreased | 0 | 2 | 0 | 0 | 0 |
Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) and physical examination reported as TEAEs are reported.
| Participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Hypertension | 1 | 0 | 0 | 0 | 0 |
| Hypotension | 1 | 0 | 0 | 0 | 0 |
| Pyrexia | 0 | 1 | 0 | 0 | 0 |
| Hypoxia | 0 | 0 | 1 | 0 | 1 |
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.
| Participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Single Beat change from baseline, Change > 30 milliseconds | 2 | 6 | 2 | 2 | 1 |
| Single Beat change from baseline, Change > 60 milliseconds | 0 | 2 | 0 | 0 | 0 |
| Single Beat change from baseline, Change > 90 milliseconds | 0 | 0 | 0 | 0 | 0 |
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.
| Percentage of participants | Oleclumab Dose 2 + Osimertinib Dose 1 |
|---|---|
| Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2 | 19 (5.4 to 41.9) |
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.
| Months | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Duration of Response (DoR) Per RECIST v 1.1 for Parts 1 and 2 | 11.4 (4.8 to 18.1) | NA (9.2 to NA) | — | — | — |
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.
| Percentage of participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Percentage of Participants With Disease Control (DC) in Parts 1 and 2 | 80.0 (28.4 to 99.5) | 81.0 (58.1 to 94.6) | 0 (NA to NA) | 16.7 (0.4 to 64.1) | 0 (NA to NA) |
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.
| Months | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) for Parts 1 and 2 | 6.5 (1.4 to 19.8) | 11.0 (3.7 to NA) | 1.4 (0.5 to 1.8) | 1.8 (0.8 to 5.5) | 1.9 (1.4 to 2.3) |
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.
| Months | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Overall Survival (OS) for Parts 1 and 2 | 21.9 (1.4 to NA) | 24.8 (12.3 to NA) | 16.4 (1.0 to 16.4) | 27.4 (1.5 to NA) | 7.1 (1.9 to NA) |
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.
| Percentage of participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 |
|---|---|---|
| OR by T790M status positive | 100 (2.5 to 100) | 66.7 (9.4 to 99.2) |
| OR by T790M status negative | 25.0 (0.6 to 80.6) | 11.8 (1.5 to 36.4) |
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.
| Percentage of participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 |
|---|---|---|
| DC by T790M status positive | 100 (2.5 to 100) | 100 (29.2 to 100) |
| DC by T790M status negative | 75.0 (19.4 to 99.4) | 82.4 (56.6 to 96.2) |
The CEOI of oleclumab is reported.
| µg/mL | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Day 1 | 545.7 ± 22.29 | 787.6 ± 31.27 | 494.6 ± 23.69 | 385.4 ± 23.51 | 633.3 ± 33.45 |
| Day 57 | 926.4 ± 15.55 | 1183 ± 24.76 | — | NA ± NA | NA ± NA |
The Ctrough of oleclumab is reported.
| µg/mL | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Observed Lowest Serum Concentration (Ctrough) of MEDI9447 Over Time | 271.5 ± 38.03 | 315.5 ± 35.42 | — | NA ± NA | NA ± NA |
The Cmax of osimertinib and AZ5104 are reported.
| nM | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 |
|---|---|---|
| Osimertinib, Day 1 | 151.9 ± 18.73 | 130.5 ± 92.63 |
| Osimertinib, Day 29 | 529.9 ± 28.46 | 484.9 ± 48.69 |
| AZ5104, Day 1 | 3.271 ± 60.73 | 3.954 ± 72.97 |
| AZ5104, Day 29 | 52.06 ± 43.62 | 45.30 ± 53.84 |
The Cmax of AZD4635, SSP-005173X, and SSP-005174X are reported.
| ng/mL | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|
| AZD4635, Day 1 | 548.2 ± 19.57 | 330.6 ± 34.02 | 319.5 ± 17.93 |
| AZD4635, Day 57 | — | NA ± NA | NA ± NA |
| SSP-005173X, Day 1 | 9.238 ± 62.78 | 12.54 ± 52.36 | 6.747 ± 66.91 |
| SSP-005173X, Day 57 | — | NA ± NA | NA ± NA |
| SSP-005174X, Day 1 | 67.78 ± 30.28 | 58.18 ± 54.66 | 40.60 ± 32.19 |
| SSP-005174X, Day 57 | — | NA ± NA | NA ± NA |
The Tmax of AZD4635, SSP-005173X, and SSP-005174X are reported.
| Hour | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|
| AZD4635, Day 1 | 1.03 (1.00 to 2.13) | 1.07 (1.00 to 1.08) | 1.05 (1.02 to 1.22) |
| AZD4635, Day 57 | — | NA (NA to 2.13) | NA (0.917 to 1.00) |
| SSP-005173X, Day 1 | 1.54 (1.00 to 2.13) | 1.93 (1.02 to 2.03) | 1.22 (1.02 to 2.07) |
| SSP-005173X, Day 57 | — | NA (NA to 2.13) | NA (0.917 to 1.00) |
| SSP-005174X, Day 1 | 1.03 (1.00 to 2.13) | 1.07 (1.00 to 1.87) | 1.05 (1.02 to 1.22) |
| SSP-005174X, Day 57 | — | NA (NA to 2.13) | NA (NA to 1.00) |
The AUC0-24 of AZD4635, SSP-005173X, and SSP-005174X are reported.
| h*ng/mL | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|
| AZD4635, Day 1 | 2546 ± 27.24 | 1324 ± 28.02 | 1624 ± 20.32 |
| AZD4635, Day 57 | — | NA ± NA | NA ± NA |
| SSP-005173X, Day 1 | 84.08 ± 94.72 | 76.57 ± 68.17 | 59.88 ± 61.87 |
| SSP-005173X, Day 57 | — | NA ± NA | NA ± NA |
| SSP-005174X, Day 1 | 304.4 ± 54.74 | 231.9 ± 65.94 | 192.4 ± 24.54 |
| SSP-005174X, Day 57 | — | NA ± NA | NA ± NA |
Number of participants with positive post-baseline for anti-oleclumab antibodies are reported.
| Participants | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| Number of Participants With Positive Post-baseline for Anti-oleclumab Antibodies | 1 | 0 | 0 | 0 | 0 |
Collected over From Day 1 through 90 days of the last dose of study drug (approximately 37 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oleclumab Dose 1 + Osimertinib Dose 1 | 2/5 (40%) | 3/5 (60%) | 5/5 (100%) |
| Oleclumab Dose 2 + Osimertinib Dose 1 | 9/21 (42.9%) | 6/21 (28.6%) | 21/21 (100%) |
| Oleclumab Dose 1 + AZD4635 Dose 1 | 3/6 (50%) | 4/6 (66.7%) | 6/6 (100%) |
| Oleclumab Dose 1 + AZD4635 Dose 2 | 2/6 (33.3%) | 1/6 (16.7%) | 5/6 (83.3%) |
| Oleclumab Dose 2 + AZD4635 Dose 2 | 3/5 (60%) | 3/5 (60%) | 5/5 (100%) |
| Event | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/5 | 0/21 | 0/6 | 0/6 | 1/5 |
| Small intestinal obstructionGastrointestinal disorders | 0/5 | 0/21 | 0/6 | 0/6 | 1/5 |
| FatigueGeneral disorders | 0/5 | 0/21 | 0/6 | 0/6 | 1/5 |
| CystitisInfections and infestations | 1/5 | 0/21 | 0/6 | 0/6 | 0/5 |
| HyponatraemiaMetabolism and nutrition disorders | 1/5 | 0/21 | 0/6 | 0/6 | 0/5 |
| Spinal cord compressionNervous system disorders | 1/5 | 0/21 | 0/6 | 0/6 | 0/5 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/5 | 1/21 | 0/6 | 1/6 | 1/5 |
| HaemorrhageVascular disorders | 1/5 | 0/21 | 0/6 | 0/6 | 0/5 |
| Liver abscessInfections and infestations | 0/5 | 0/21 | 1/6 | 0/6 | 0/5 |
| Pericardial effusionCardiac disorders | 0/5 | 1/21 | 0/6 | 1/6 | 0/5 |
| Event | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 |
|---|---|---|---|---|---|
| VomitingGastrointestinal disorders | 0/5 | 1/21 | 5/6 | 1/6 | 1/5 |
| NauseaGastrointestinal disorders | 0/5 | 4/21 | 4/6 | 3/6 | 2/5 |
| ParonychiaInfections and infestations | 3/5 | 6/21 | 0/6 | 0/6 | 0/5 |
| ConstipationGastrointestinal disorders | 1/5 | 2/21 | 1/6 | 3/6 | 0/5 |
| HeadacheNervous system disorders | 0/5 | 3/21 | 2/6 | 3/6 | 0/5 |
| AnaemiaBlood and lymphatic system disorders | 2/5 | 0/21 | 1/6 | 1/6 | 0/5 |
| DehydrationMetabolism and nutrition disorders | 0/5 | 0/21 | 0/6 | 0/6 | 2/5 |
| DizzinessNervous system disorders | 0/5 | 2/21 | 2/6 | 0/6 | 2/5 |
| HypoaesthesiaNervous system disorders | 0/5 | 0/21 | 0/6 | 0/6 | 2/5 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/5 | 2/21 | 0/6 | 2/6 | 2/5 |
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
| Age, Continuous(Years) | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 | Total |
|---|---|---|---|---|---|---|
| Mean | 61.2 ± 2.9 | 61.4 ± 10.3 | 64.5 ± 10.3 | 65.2 ± 13.1 | 70.6 ± 8.8 | 63.4 ± 10.0 |
| Sex: Female, Male(Participants) | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 | Total |
|---|---|---|---|---|---|---|
| Female | 4 | 10 | 4 | 5 | 4 | 27 |
| Male | 1 | 11 | 2 | 1 | 1 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 21 | 6 | 6 | 5 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Oleclumab Dose 1 + Osimertinib Dose 1 | Oleclumab Dose 2 + Osimertinib Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 1 | Oleclumab Dose 1 + AZD4635 Dose 2 | Oleclumab Dose 2 + AZD4635 Dose 2 | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 4 | 19 | 0 | 2 | 1 | 26 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 1 | 2 | 6 | 4 | 4 | 17 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from May 2018 to primary completion in May 2021, 36 months.
Results were first posted in Jul 2022, 1 year 2 months after primary completion.
Of 308 industry-sponsored phase 1/2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 77. This study's 36 months is below that.
Counting every sponsor, half of 431 studies reached it within 63 months; a quarter within 42 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →