Trial Outcomes & Findings for Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study (NCT NCT03381274)

NCT ID: NCT03381274

Last Updated: 2025-12-23

Results Overview

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.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: From Day 1 to Day 28 after first dose of study drug
• Results posted on: 2025-12-23

Participant Flow

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.

Participant milestones

Measure	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).	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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Overall Study STARTED	5	21	6	6	5
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	5	21	6	6	5

Reasons for withdrawal

Measure	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).	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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Overall Study Death	2	9	3	2	3
Overall Study Lost to Follow-up	0	0	0	1	0
Overall Study Withdrawal by Subject	2	1	3	1	0
Overall Study Other	1	11	0	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Total n=43 Participants Total of all reporting groups
Age, Continuous	61.2 Years STANDARD_DEVIATION 2.9 • n=68 Participants	61.4 Years STANDARD_DEVIATION 10.3 • n=4 Participants	64.5 Years STANDARD_DEVIATION 10.3 • n=219 Participants	65.2 Years STANDARD_DEVIATION 13.1 • n=219 Participants	70.6 Years STANDARD_DEVIATION 8.8 • n=880 Participants	63.4 Years STANDARD_DEVIATION 10.0 • n=6 Participants
Sex: Female, Male Female	4 Participants n=68 Participants	10 Participants n=4 Participants	4 Participants n=219 Participants	5 Participants n=219 Participants	4 Participants n=880 Participants	27 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=68 Participants	11 Participants n=4 Participants	2 Participants n=219 Participants	1 Participants n=219 Participants	1 Participants n=880 Participants	16 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=68 Participants	21 Participants n=4 Participants	6 Participants n=219 Participants	6 Participants n=219 Participants	5 Participants n=880 Participants	43 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	4 Participants n=68 Participants	19 Participants n=4 Participants	0 Participants n=219 Participants	2 Participants n=219 Participants	1 Participants n=880 Participants	26 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	1 Participants n=68 Participants	2 Participants n=4 Participants	6 Participants n=219 Participants	4 Participants n=219 Participants	4 Participants n=880 Participants	17 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 28 after first dose of study drug

Population: 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.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=4 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=3 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=4 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=3 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Parts 1 and 2 Any TEAEs	21 Participants	6 Participants	5 Participants	5 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Parts 1 and 2 Any TESAEs	6 Participants	4 Participants	1 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology, clinical chemistry, thyroid function tests, and urinalysis.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypothyroidism	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Blood creatine phosphokinase increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Platelet count decreased	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Blood creatinine increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Lipase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypercholesterolaemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hyperkalaemia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypoalbuminaemia	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypomagnesaemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hyponatraemia	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypophosphataemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Leukopenia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Blood albumin decreased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Aspartate aminotransferase increased	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypocalcaemia	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypokalaemia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Haemoglobin decreased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Neutrophil count decreased	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 White blood cell count decreased	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hypercalcaemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Thrombocytopenia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Alanine aminotransferase increased	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Hyperglycaemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Blood alkaline phosphatase increased	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Amylase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Anaemia	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2 Neutropenia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) and physical examination reported as TEAEs are reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2 Hypertension	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2 Pyrexia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2 Hypoxia	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2 Hypotension	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Number of Participants With Notable QTc Interval in Parts 1 and 2 Single Beat change from baseline, Change > 30 milliseconds	6 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Notable QTc Interval in Parts 1 and 2 Single Beat change from baseline, Change > 60 milliseconds	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Notable QTc Interval in Parts 1 and 2 Single Beat change from baseline, Change > 90 milliseconds	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

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.

Outcome measures

Measure	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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=21 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2	—	—	—	—	19 Percentage of participants Interval 5.4 to 41.9

SECONDARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: 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.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=4 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=2 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Duration of Response (DoR) Per RECIST v 1.1 for Parts 1 and 2	NA Months Interval 9.2 to Median and upper limit of 95% confidence interval (CI) were not derived due to insufficient events being observed at the time of the analysis.	—	—	—	11.4 Months Interval 4.8 to 18.1

SECONDARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Percentage of Participants With Disease Control (DC) in Parts 1 and 2	81.0 Percentage of participants Interval 58.1 to 94.6	0 Percentage of participants 95% CI was not derived due to insufficient events being observed at the time of the analysis.	16.7 Percentage of participants Interval 0.4 to 64.1	0 Percentage of participants 95% CI was not derived due to insufficient events being observed at the time of the analysis.	80.0 Percentage of participants Interval 28.4 to 99.5

SECONDARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Progression Free Survival (PFS) for Parts 1 and 2	11.0 Months Interval 3.7 to Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.	1.4 Months Interval 0.5 to 1.8	1.8 Months Interval 0.8 to 5.5	1.9 Months Interval 1.4 to 2.3	6.5 Months Interval 1.4 to 19.8

SECONDARY outcome

Timeframe: From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Overall Survival (OS) for Parts 1 and 2	24.8 Months Interval 12.3 to Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.	16.4 Months Interval 1.0 to 16.4	27.4 Months Interval 1.5 to Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.	7.1 Months Interval 1.9 to Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.	21.9 Months Interval 1.4 to Upper limit of 95% CI was not derived due to insufficient events being observed at the time of the analysis.

SECONDARY outcome

Timeframe: From Baseline (Days -28 to -1) through 90 days of the last dose of study drug (approximately 37 months)

Population: 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.

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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=20 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Percentage of Participants With OR by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2 OR by T790M status positive	66.7 Percentage of participants Interval 9.4 to 99.2	—	—	—	100 Percentage of participants Interval 2.5 to 100.0
Percentage of Participants With OR by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2 OR by T790M status negative	11.8 Percentage of participants Interval 1.5 to 36.4	—	—	—	25.0 Percentage of participants Interval 0.6 to 80.6

SECONDARY outcome

Timeframe: From Baseline (Days -28 to -1) through 90 days of the last dose of study drug (approximately 37 months)

Population: 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 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.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=20 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Percentage of Participants With DC by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2 DC by T790M status positive	100 Percentage of participants Interval 29.2 to 100.0	—	—	—	100 Percentage of participants Interval 2.5 to 100.0
Percentage of Participants With DC by T790M Status at Baseline (Determined by a Central Laboratory) for Parts 1 and 2 DC by T790M status negative	82.4 Percentage of participants Interval 56.6 to 96.2	—	—	—	75.0 Percentage of participants Interval 19.4 to 99.4

SECONDARY outcome

Timeframe: Predose (within 90 minutes prior to start of infusion) and postdose (10 minutes after the end of infusion) on Days 1 and 57

Population: 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.

The CEOI of oleclumab is reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=3 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Observed Serum Concentration at the Time of End of Infusion (CEOI) of Oleclumab (MEDI9447) Over Time Day 1	787.6 µg/mL Geometric Coefficient of Variation 31.27	494.6 µg/mL Geometric Coefficient of Variation 23.69	385.4 µg/mL Geometric Coefficient of Variation 23.51	633.3 µg/mL Geometric Coefficient of Variation 33.45	545.7 µg/mL Geometric Coefficient of Variation 22.29
Observed Serum Concentration at the Time of End of Infusion (CEOI) of Oleclumab (MEDI9447) Over Time Day 57	1183 µg/mL Geometric Coefficient of Variation 24.76	—	NA µg/mL Geometric Coefficient of Variation NA Geometric mean and geometric coefficient of variation (CV) were not derived due to insufficient observations (n\<3) at the specified time point.	NA µg/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	926.4 µg/mL Geometric Coefficient of Variation 15.55

SECONDARY outcome

Timeframe: Predose (within 90 minutes prior to start of infusion) on Day 57

Population: 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.

The Ctrough of oleclumab is reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=18 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=2 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=2 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=3 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Observed Lowest Serum Concentration (Ctrough) of MEDI9447 Over Time	315.5 µg/mL Geometric Coefficient of Variation 35.42	—	NA µg/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	NA µg/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	271.5 µg/mL Geometric Coefficient of Variation 38.03

SECONDARY outcome

Timeframe: Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, and 4 hours) on Days 1 and 29

Population: 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.

The Cmax of osimertinib and AZ5104 are reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Maximum Plasma Concentration (Cmax) of Osimertinib and Its Metabolite (AZ5104) AZ5104, Day 29	45.30 nM Geometric Coefficient of Variation 53.84	—	—	—	52.06 nM Geometric Coefficient of Variation 43.62
Maximum Plasma Concentration (Cmax) of Osimertinib and Its Metabolite (AZ5104) Osimertinib, Day 1	130.5 nM Geometric Coefficient of Variation 92.63	—	—	—	151.9 nM Geometric Coefficient of Variation 18.73
Maximum Plasma Concentration (Cmax) of Osimertinib and Its Metabolite (AZ5104) Osimertinib, Day 29	484.9 nM Geometric Coefficient of Variation 48.69	—	—	—	529.9 nM Geometric Coefficient of Variation 28.46
Maximum Plasma Concentration (Cmax) of Osimertinib and Its Metabolite (AZ5104) AZ5104, Day 1	3.954 nM Geometric Coefficient of Variation 72.97	—	—	—	3.271 nM Geometric Coefficient of Variation 60.73

SECONDARY outcome

Timeframe: Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57

Population: 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.

The Cmax of AZD4635, SSP-005173X, and SSP-005174X are reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=6 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=3 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005173X, Day 1	12.54 ng/mL Geometric Coefficient of Variation 52.36	6.747 ng/mL Geometric Coefficient of Variation 66.91	—	—	9.238 ng/mL Geometric Coefficient of Variation 62.78
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005173X, Day 57	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005174X, Day 1	58.18 ng/mL Geometric Coefficient of Variation 54.66	40.60 ng/mL Geometric Coefficient of Variation 32.19	—	—	67.78 ng/mL Geometric Coefficient of Variation 30.28
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005174X, Day 57	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) AZD4635, Day 1	330.6 ng/mL Geometric Coefficient of Variation 34.02	319.5 ng/mL Geometric Coefficient of Variation 17.93	—	—	548.2 ng/mL Geometric Coefficient of Variation 19.57
Cmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) AZD4635, Day 57	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were no derived due to insufficient observations (n\<3) at the specified time point.	—	—	—

SECONDARY outcome

Timeframe: Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57

Population: 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.

The Tmax of AZD4635, SSP-005173X, and SSP-005174X are reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=6 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=3 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) AZD4635, Day 1	1.07 Hour Interval 1.0 to 1.08	1.05 Hour Interval 1.02 to 1.22	—	—	1.03 Hour Interval 1.0 to 2.13
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) AZD4635, Day 57	NA Hour Interval to 2.13 Median and upper limit of range were not derived due to insufficient observations (n\<3) at the specified time point.	NA Hour Interval 0.917 to 1.0 Median was not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005173X, Day 1	1.93 Hour Interval 1.02 to 2.03	1.22 Hour Interval 1.02 to 2.07	—	—	1.54 Hour Interval 1.0 to 2.13
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005173X, Day 57	NA Hour Interval to 2.13 Median and lower limit of range were not derived due to insufficient observations (n\<3) at the specified time point.	NA Hour Interval 0.917 to 1.0 Median was not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005174X, Day 1	1.07 Hour Interval 1.0 to 1.87	1.05 Hour Interval 1.02 to 1.22	—	—	1.03 Hour Interval 1.0 to 2.13
Tmax of AZD4635 and Its Metabolites (SSP-005173X and SSP-005174X) SSP-005174X, Day 57	NA Hour Interval to 2.13 Median and lower limit of range were not derived due to insufficient observations (n\<3) at the specified time point.	NA Hour Interval to 1.0 Median and lower limit of range were not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—

SECONDARY outcome

Timeframe: Predose (within 90 minutes prior to start of infusion) and postdose (1, 2, 4, 6, and 24 hours) on Days 1 and 57

Population: 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.

The AUC0-24 of AZD4635, SSP-005173X, and SSP-005174X are reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=6 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=3 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
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) AZD4635, Day 1	1324 h*ng/mL Geometric Coefficient of Variation 28.02	1624 h*ng/mL Geometric Coefficient of Variation 20.32	—	—	2546 h*ng/mL Geometric Coefficient of Variation 27.24
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) AZD4635, Day 57	NA h*ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	NA h*ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—
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) SSP-005173X, Day 1	76.57 h*ng/mL Geometric Coefficient of Variation 68.17	59.88 h*ng/mL Geometric Coefficient of Variation 61.87	—	—	84.08 h*ng/mL Geometric Coefficient of Variation 94.72
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) SSP-005173X, Day 57	NA h*ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	NA h*ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—
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) SSP-005174X, Day 1	231.9 h*ng/mL Geometric Coefficient of Variation 65.94	192.4 h*ng/mL Geometric Coefficient of Variation 24.54	—	—	304.4 h*ng/mL Geometric Coefficient of Variation 54.74
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) SSP-005174X, Day 57	NA h*ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	NA h*ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV were not derived due to insufficient observations (n\<3) at the specified time point.	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.

Number of participants with positive post-baseline for anti-oleclumab antibodies are reported.

Outcome measures

Measure	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 Participants 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 Participants In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).
Number of Participants With Positive Post-baseline for Anti-oleclumab Antibodies	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

Oleclumab Dose 1 + Osimertinib Dose 1

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Oleclumab Dose 2 + Osimertinib Dose 1

Serious events: 6 serious events

Other events: 21 other events

Deaths: 9 deaths

Oleclumab Dose 1 + AZD4635 Dose 1

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

Oleclumab Dose 1 + AZD4635 Dose 2

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

Oleclumab Dose 2 + AZD4635 Dose 2

Serious events: 3 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Measure	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 participants at risk 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
Gastrointestinal disorders Nausea	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hyponatraemia	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
General disorders Fatigue	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Infections and infestations Cystitis	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Infections and infestations Liver abscess	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Infections and infestations Pneumonia	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Cardiac disorders Pericardial effusion	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Cerebral infarction	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Spinal cord compression	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Vascular disorders Haemorrhage	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Other adverse events

Measure	Oleclumab Dose 1 + Osimertinib Dose 1 n=5 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD).	Oleclumab Dose 2 + Osimertinib Dose 1 n=21 participants at risk 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.	Oleclumab Dose 1 + AZD4635 Dose 1 n=6 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD.	Oleclumab Dose 1 + AZD4635 Dose 2 n=6 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD.	Oleclumab Dose 2 + AZD4635 Dose 2 n=5 participants at risk In Part 1 (dose-escalation), participants received intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD.
General disorders Face oedema	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
General disorders Fatigue	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	19.0% 4/21 • Number of events 4 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	33.3% 2/6 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
General disorders Localised oedema	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
General disorders Malaise	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
General disorders Non-cardiac chest pain	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
General disorders Pain	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Immune system disorders Anaphylactic reaction	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Infections and infestations Herpes zoster	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Infections and infestations Paronychia	60.0% 3/5 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	28.6% 6/21 • Number of events 7 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Infections and infestations Pneumonia	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • Number of events 5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 7 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Blood creatinine increased	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Ejection fraction decreased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Haemoglobin decreased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Lipase increased	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Neutrophil count decreased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Platelet count decreased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations White blood cell count decreased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	19.0% 4/21 • Number of events 5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	40.0% 2/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Failure to thrive	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hyperkalaemia	20.0% 1/5 • Number of events 5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hypoalbuminaemia	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hypocalcaemia	20.0% 1/5 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Metabolism and nutrition disorders Hypophosphataemia	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Musculoskeletal and connective tissue disorders Muscular weakness	20.0% 1/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	20.0% 1/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Endocrine disorders Hypothyroidism	20.0% 1/5 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Brain oedema	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Dizziness	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	33.3% 2/6 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	40.0% 2/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Headache	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	33.3% 2/6 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	50.0% 3/6 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Hypoaesthesia	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	40.0% 2/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Neuropathy peripheral	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Seizure	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Eye disorders Visual brightness	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Nervous system disorders Tremor	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Psychiatric disorders Anxiety	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Psychiatric disorders Depression	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Psychiatric disorders Insomnia	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Renal and urinary disorders Chronic kidney disease	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Renal and urinary disorders Hydronephrosis	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Vascular disorders Hypotension	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Nausea	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	19.0% 4/21 • Number of events 7 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	66.7% 4/6 • Number of events 6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	50.0% 3/6 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	40.0% 2/5 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Stomatitis	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	28.6% 6/21 • Number of events 6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Vomiting	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 4 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	83.3% 5/6 • Number of events 6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Blood and lymphatic system disorders Anaemia	40.0% 2/5 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
General disorders Chest discomfort	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Haemorrhoids	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	50.0% 3/6 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	23.8% 5/21 • Number of events 11 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Dyspepsia	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Gastritis	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Alanine aminotransferase increased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Amylase increased	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Aspartate aminotransferase increased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Investigations Blood albumin decreased	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	9.5% 2/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	33.3% 2/6 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	40.0% 2/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	14.3% 3/21 • Number of events 3 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	14.3% 3/21 • Number of events 5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	33.3% 7/21 • Number of events 8 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Skin and subcutaneous tissue disorders Urticaria	20.0% 1/5 • Number of events 2 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	4.8% 1/21 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Vascular disorders Flushing	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	16.7% 1/6 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)
Vascular disorders Hypertension	20.0% 1/5 • Number of events 1 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/21 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/6 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)	0.00% 0/5 • From Day 1 through 90 days of the last dose of study drug (approximately 37 months)

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
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