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Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04644237
Recruitment Status : Active, not recruiting
First Posted : November 25, 2020
Results First Posted : January 30, 2024
Last Update Posted : April 3, 2024
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Trastuzumab deruxtecan
Enrollment 152
Recruitment Details A total of 152 participants were randomized to T-DXd treatment in 47 clinical sites, including North America, Europe, and Asia-Pacific.
Pre-assignment Details  
Arm/Group Title Trastuzumab Deruxtecan 5.4 mg/kg Trastuzumab Deruxtecan 6.4 mg/kg
Hide Arm/Group Description Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W). Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
Period Title: Overall Study
Started [1] 102 50
Completed 27 14
Not Completed 75 36
Reason Not Completed
Death             3             2
Adverse Event             15             12
Progressive Disease             47             19
Clinical Progression             4             1
Withdrawal by Subject             1             2
Physician Decision             3             0
Other             1             0
Randomized but not Treated             1             0
[1]
Completed = Participants ongoing treatment as of 23 Dec 2022, Not Completed = Participants who discontinued treatment
Arm/Group Title Trastuzumab Deruxtecan 5.4 mg/kg Trastuzumab Deruxtecan 6.4 mg/kg Total
Hide Arm/Group Description Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W). Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W). Total of all reporting groups
Overall Number of Baseline Participants 102 50 152
Hide Baseline Analysis Population Description
The baseline demographic characteristics were assessed in the Full Analysis Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 50 participants 152 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
  60.8%
35
  70.0%
97
  63.8%
>=65 years
40
  39.2%
15
  30.0%
55
  36.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 50 participants 152 participants
59.8  (11.59) 59.5  (12.14) 59.7  (11.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 50 participants 152 participants
Female
65
  63.7%
34
  68.0%
99
  65.1%
Male
37
  36.3%
16
  32.0%
53
  34.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 50 participants 152 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
65
  63.7%
31
  62.0%
96
  63.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   4.0%
2
   1.3%
White
23
  22.5%
5
  10.0%
28
  18.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
14
  13.7%
12
  24.0%
26
  17.1%
1.Primary Outcome
Title Percentage of Participants With Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
Hide Description Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), was assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time Frame 9 months after the last participant is randomized to data cut off, up to approximately 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
Arm/Group Title Trastuzumab Deruxtecan 5.4 mg/kg Trastuzumab Deruxtecan 6.4 mg/kg
Hide Arm/Group Description:
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
Overall Number of Participants Analyzed 102 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49.0
(39.0 to 59.1)
56.0
(41.3 to 70.0)
2.Secondary Outcome
Title Percentage of Participants With Confirmed Objective Response Rate by Investigator Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung CancerTumors
Hide Description Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time Frame 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
Hide Description Duration of response (DoR) is defined as the time from the initial response (complete response [CR] or partial response [PR]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time Frame 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
Hide Description Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Time Frame 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Progression-free Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
Hide Description Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.
Time Frame 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
Hide Description Overall survival (OS) is defined as the time from date of randomization until death from any cause.
Time Frame 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title The Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
Hide Description [Not Specified]
Time Frame 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Pharmacokinetic Parameter Minimum Observed Concentration (Ctrough) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Pharmacokinetic Parameter Area Under the Serum Concentration-Time Curve (AUC) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Incidence of Anti-Drug Antibodies (ADA) Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
Hide Description [Not Specified]
Time Frame Pre-dose on Day 1 of Cycles 1, 2 and 4, and then every 4 cycles (each cycle is 21 days)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
Hide Description

The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels.

scales.
Time Frame On Day 1 of every cycle (each cycle is 21 days), and at end of treatment visit 40-day follow-up visit
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
Hide Description The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
Time Frame On Day 1 of every cycle (each cycle is 21 days), and at end of treatment visit 40-day follow-up visit
Outcome Measure Data Not Reported
Time Frame Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to 21 months. For Primary Results, data was collected up until December 23, 2022.
Adverse Event Reporting Description A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating study treatment up until 47 days after the last dose of the study treatment. Safety Analysis Set included all randomized subjects who received at least one dose of study treatment.
 
Arm/Group Title Trastuzumab Deruxtecan 5.4 mg/kg Trastuzumab Deruxtecan 6.4 mg/kg
Hide Arm/Group Description Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W). Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
All-Cause Mortality
Trastuzumab Deruxtecan 5.4 mg/kg Trastuzumab Deruxtecan 6.4 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   37/101 (36.63%)   14/50 (28.00%) 
Hide Serious Adverse Events
Trastuzumab Deruxtecan 5.4 mg/kg Trastuzumab Deruxtecan 6.4 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   37/101 (36.63%)   20/50 (40.00%) 
Blood and lymphatic system disorders     
Thrombocytopenia † 1  2/101 (1.98%)  0/50 (0.00%) 
Anaemia † 1  0/101 (0.00%)  2/50 (4.00%) 
Cardiac disorders     
Myocarditis † 1  2/101 (1.98%)  0/50 (0.00%) 
Acute myocardial infarction † 1  1/101 (0.99%)  0/50 (0.00%) 
Pericardial effusion † 1  1/101 (0.99%)  1/50 (2.00%) 
Endocrine disorders     
Hypothyroidism † 1  1/101 (0.99%)  0/50 (0.00%) 
Eye disorders     
Optic nerve disorder † 1  1/101 (0.99%)  0/50 (0.00%) 
Gastrointestinal disorders     
Nausea † 1  2/101 (1.98%)  0/50 (0.00%) 
Vomiting † 1  2/101 (1.98%)  1/50 (2.00%) 
Diarrhoea † 1  1/101 (0.99%)  2/50 (4.00%) 
Duodenal ulcer † 1  1/101 (0.99%)  0/50 (0.00%) 
Ileus † 1  1/101 (0.99%)  0/50 (0.00%) 
Intestinal perforation † 1  1/101 (0.99%)  0/50 (0.00%) 
Large intestinal obstruction † 1  1/101 (0.99%)  0/50 (0.00%) 
Colitis † 1  0/101 (0.00%)  1/50 (2.00%) 
Enterocolitis † 1  0/101 (0.00%)  1/50 (2.00%) 
Odynophagia † 1  0/101 (0.00%)  1/50 (2.00%) 
General disorders     
Fatigue † 1  1/101 (0.99%)  2/50 (4.00%) 
General physical health deterioration † 1  1/101 (0.99%)  0/50 (0.00%) 
Pyrexia † 1  1/101 (0.99%)  0/50 (0.00%) 
Malaise † 1  0/101 (0.00%)  2/50 (4.00%) 
Infections and infestations     
Pneumonia † 1  2/101 (1.98%)  3/50 (6.00%) 
COVID-19 † 1  1/101 (0.99%)  0/50 (0.00%) 
COVID-19 pneumonia † 1  1/101 (0.99%)  0/50 (0.00%) 
Urinary tract infection † 1  1/101 (0.99%)  1/50 (2.00%) 
Meningitis † 1  0/101 (0.00%)  1/50 (2.00%) 
Post procedural infection † 1  0/101 (0.00%)  1/50 (2.00%) 
Injury, poisoning and procedural complications     
Subdural haemorrhage † 1  1/101 (0.99%)  0/50 (0.00%) 
Investigations     
Troponin I increased † 1  2/101 (1.98%)  0/50 (0.00%) 
Neutrophil count decreased † 1  1/101 (0.99%)  2/50 (4.00%) 
Platelet count decreased † 1  1/101 (0.99%)  2/50 (4.00%) 
General physical condition abnormal † 1  0/101 (0.00%)  1/50 (2.00%) 
Metabolism and nutrition disorders     
Dehydration † 1  0/101 (0.00%)  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/101 (0.99%)  0/50 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant † 1  2/101 (1.98%)  0/50 (0.00%) 
Malignant neoplasm progression † 1  2/101 (1.98%)  0/50 (0.00%) 
Cancer pain † 1  1/101 (0.99%)  0/50 (0.00%) 
Intracranial tumour haemorrhage † 1  1/101 (0.99%)  0/50 (0.00%) 
Nervous system disorders     
Cerebrovascular accident † 1  1/101 (0.99%)  0/50 (0.00%) 
Intracranial pressure increased † 1  1/101 (0.99%)  0/50 (0.00%) 
Neurological symptom † 1  1/101 (0.99%)  1/50 (2.00%) 
Hydrocephalus † 1  0/101 (0.00%)  1/50 (2.00%) 
Psychiatric disorders     
Anxiety † 1  0/101 (0.00%)  1/50 (2.00%) 
Disorientation † 1  0/101 (0.00%)  1/50 (2.00%) 
Renal and urinary disorders     
Ureteric obstruction † 1  1/101 (0.99%)  0/50 (0.00%) 
Acute kidney injury † 1  0/101 (0.00%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion † 1  4/101 (3.96%)  1/50 (2.00%) 
Dyspnoea † 1  2/101 (1.98%)  0/50 (0.00%) 
Interstitial lung disease † 1  2/101 (1.98%)  1/50 (2.00%) 
Pneumonitis † 1  2/101 (1.98%)  1/50 (2.00%) 
Pulmonary embolism † 1  2/101 (1.98%)  0/50 (0.00%) 
Respiratory failure † 1  2/101 (1.98%)  0/50 (0.00%) 
Pneumothorax † 1  1/101 (0.99%)  0/50 (0.00%) 
1
Term from vocabulary, MedDRA25.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trastuzumab Deruxtecan 5.4 mg/kg Trastuzumab Deruxtecan 6.4 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   101/101 (100.00%)   50/50 (100.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  37/101 (36.63%)  24/50 (48.00%) 
Neutropenia † 1  12/101 (11.88%)  8/50 (16.00%) 
Gastrointestinal disorders     
Nausea † 1  68/101 (67.33%)  41/50 (82.00%) 
Constipation † 1  37/101 (36.63%)  16/50 (32.00%) 
Vomiting † 1  31/101 (30.69%)  22/50 (44.00%) 
Diarrhoea † 1  23/101 (22.77%)  18/50 (36.00%) 
Stomatitis † 1  15/101 (14.85%)  5/50 (10.00%) 
Dyspepsia † 1  8/101 (7.92%)  1/50 (2.00%) 
Abdominal pain † 1  7/101 (6.93%)  6/50 (12.00%) 
Gastrooesophageal reflux disease † 1  4/101 (3.96%)  3/50 (6.00%) 
Haemorrhoids † 1  3/101 (2.97%)  3/50 (6.00%) 
Odynophagia † 1  0/101 (0.00%)  3/50 (6.00%) 
Toothache † 1  0/101 (0.00%)  3/50 (6.00%) 
General disorders     
Asthenia † 1  16/101 (15.84%)  13/50 (26.00%) 
Fatigue † 1  16/101 (15.84%)  7/50 (14.00%) 
Malaise † 1  16/101 (15.84%)  4/50 (8.00%) 
Pyrexia † 1  12/101 (11.88%)  6/50 (12.00%) 
Oedema peripheral † 1  4/101 (3.96%)  3/50 (6.00%) 
Chest pain † 1  3/101 (2.97%)  4/50 (8.00%) 
Infections and infestations     
COVID-19 † 1  13/101 (12.87%)  8/50 (16.00%) 
Paronychia † 1  7/101 (6.93%)  1/50 (2.00%) 
Pneumonia † 1  5/101 (4.95%)  6/50 (12.00%) 
Urinary tract infection † 1  3/101 (2.97%)  5/50 (10.00%) 
White blood cell count decreased † 1  26/101 (25.74%)  15/50 (30.00%) 
Investigations     
Neutrophil count decreased † 1  32/101 (31.68%)  20/50 (40.00%) 
Platelet count decreased † 1  25/101 (24.75%)  12/50 (24.00%) 
Aspartate aminotransferase increased † 1  19/101 (18.81%)  6/50 (12.00%) 
Alanine aminotransferase increased † 1  14/101 (13.86%)  7/50 (14.00%) 
Weight decreased † 1  11/101 (10.89%)  7/50 (14.00%) 
Blood creatinine increased † 1  6/101 (5.94%)  4/50 (8.00%) 
Blood bilirubin increased † 1  3/101 (2.97%)  8/50 (16.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  40/101 (39.60%)  25/50 (50.00%) 
Hypokalaemia † 1  13/101 (12.87%)  3/50 (6.00%) 
Hypomagnesaemia † 1  6/101 (5.94%)  2/50 (4.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  9/101 (8.91%)  3/50 (6.00%) 
Back pain † 1  6/101 (5.94%)  2/50 (4.00%) 
Muscle spasms † 1  4/101 (3.96%)  3/50 (6.00%) 
Nervous system disorders     
Dizziness † 1  13/101 (12.87%)  1/50 (2.00%) 
Headache † 1  5/101 (4.95%)  3/50 (6.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  9/101 (8.91%)  6/50 (12.00%) 
Interstitial lung disease † 1  7/101 (6.93%)  6/50 (12.00%) 
Pneumonitis † 1  6/101 (5.94%)  6/50 (12.00%) 
Dyspnoea † 1  5/101 (4.95%)  9/50 (18.00%) 
Haemoptysis † 1  2/101 (1.98%)  3/50 (6.00%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  22/101 (21.78%)  17/50 (34.00%) 
Dry skin † 1  1/101 (0.99%)  3/50 (6.00%) 
1
Term from vocabulary, MedDRA25.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sanyko, Inc
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT04644237    
Other Study ID Numbers: DS8201-A-U206
2020-003427-42 ( EudraCT Number )
First Submitted: November 19, 2020
First Posted: November 25, 2020
Results First Submitted: December 22, 2023
Results First Posted: January 30, 2024
Last Update Posted: April 3, 2024