Trial Outcomes & Findings for Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer (NCT NCT03867175)
NCT ID: NCT03867175
Last Updated: 2025-06-13
Results Overview
Will be determined using the product-limit method of Kaplan and Meier. Will compare unadjusted median PFS between the 2 arms using a log-rank test. Will also use a proportional hazards model to compare progression-free survival between the two groups, adjusting for key covariates such as age, performance (Eastern Cooperative Oncology Group) status, response to initial systemic therapy versus (vs) stable disease, the presence or absence of brain metastases, PD-L1 \[programmed death-ligand \] expression (\< 1% vs \> 50%), tumor histology (adenocarcinoma vs non-adenocarcinoma), and number of disease sites treated (1-3 sites vs 4-6 sites). Progression is defined using RECIST v1.1 is relative Increase: A 20% increase in the sum of the longest diameters of target lesions (from baseline or nadir) is a criterion for PD.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
|
Arm 2 Pembrolizumab Only
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 Participants
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
|
Arm 2 Pembrolizumab Only
n=1 Participants
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
53 years
n=4 Participants
|
59.8 years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsWill be determined using the product-limit method of Kaplan and Meier. Will compare unadjusted median PFS between the 2 arms using a log-rank test. Will also use a proportional hazards model to compare progression-free survival between the two groups, adjusting for key covariates such as age, performance (Eastern Cooperative Oncology Group) status, response to initial systemic therapy versus (vs) stable disease, the presence or absence of brain metastases, PD-L1 \[programmed death-ligand \] expression (\< 1% vs \> 50%), tumor histology (adenocarcinoma vs non-adenocarcinoma), and number of disease sites treated (1-3 sites vs 4-6 sites). Progression is defined using RECIST v1.1 is relative Increase: A 20% increase in the sum of the longest diameters of target lesions (from baseline or nadir) is a criterion for PD.
Outcome measures
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 Participants
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
There were 4 participants in Arm 1. One person progressed (date of progression, 1/8/2020; date of death 2/18/2020; study start date 6/24/2019).
The remaining 3 are censored (no progression, no death) and still alive as of April 23, 2025.
|
Arm 2 Pembrolizumab Only
n=1 Participants
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
The one participant in this arm is alive and censored (no progression, no death) as of April 23, 2025.
|
|---|---|---|
|
Number of Participants With Progression-free Survival (PFS) After Completion of First Line Standard of Care Systemic Therapy
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsOverall Survival is defined as the duration from the start of first line standard of care systemic therapy to the date of death or date of last contact; those lost to follow-up will be censored and will be reported with an exact 95% confidence interval.
Outcome measures
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 Participants
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
There were 4 participants in Arm 1. One person progressed (date of progression, 1/8/2020; date of death 2/18/2020; study start date 6/24/2019).
The remaining 3 are censored (no progression, no death) and still alive as of April 23, 2025.
|
Arm 2 Pembrolizumab Only
n=1 Participants
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
The one participant in this arm is alive and censored (no progression, no death) as of April 23, 2025.
|
|---|---|---|
|
Number of Participants With Overall Survival
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsIn patients not receiving radiation, the investigators will assess progression at their known sites of disease prior to beginning first line systemic chemotherapy.
Outcome measures
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 Participants
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
There were 4 participants in Arm 1. One person progressed (date of progression, 1/8/2020; date of death 2/18/2020; study start date 6/24/2019).
The remaining 3 are censored (no progression, no death) and still alive as of April 23, 2025.
|
Arm 2 Pembrolizumab Only
n=1 Participants
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
The one participant in this arm is alive and censored (no progression, no death) as of April 23, 2025.
|
|---|---|---|
|
Number of Participants With Progression
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsInvestigators will assess the rate of failures inside and outside of radiation treatment.
Outcome measures
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 Participants
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
There were 4 participants in Arm 1. One person progressed (date of progression, 1/8/2020; date of death 2/18/2020; study start date 6/24/2019).
The remaining 3 are censored (no progression, no death) and still alive as of April 23, 2025.
|
Arm 2 Pembrolizumab Only
n=1 Participants
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
The one participant in this arm is alive and censored (no progression, no death) as of April 23, 2025.
|
|---|---|---|
|
Number of Participants to Have a Rate of Failure
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 5 yearsInvestigators will assess the development of new sites of disease during or after immunotherapy
Outcome measures
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 Participants
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
There were 4 participants in Arm 1. One person progressed (date of progression, 1/8/2020; date of death 2/18/2020; study start date 6/24/2019).
The remaining 3 are censored (no progression, no death) and still alive as of April 23, 2025.
|
Arm 2 Pembrolizumab Only
n=1 Participants
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
The one participant in this arm is alive and censored (no progression, no death) as of April 23, 2025.
|
|---|---|---|
|
Number of Participants With New Sites of Disease
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsAll safety measures, including acute and late toxicity, will be reported using descriptive statistics (mean, median, standard deviation, proportions, and 95% confidence intervals). This will include calculating frequency/risk of adverse events by treatment site. Potential toxicities reported would include pneumonitis, esophagitis, chest wall pain, dermatologic toxicity, renal dysfunction, gastrointestinal toxicity including nausea, vomiting, and diarrhea, hepatotoxicity, and abdominal pain. These toxicities would be assessed according to site of irradiation by the treating physician and graded as per Common Terminology Criteria for Adverse Events 5.
Outcome measures
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 Participants
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
There were 4 participants in Arm 1. One person progressed (date of progression, 1/8/2020; date of death 2/18/2020; study start date 6/24/2019).
The remaining 3 are censored (no progression, no death) and still alive as of April 23, 2025.
|
Arm 2 Pembrolizumab Only
n=1 Participants
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
The one participant in this arm is alive and censored (no progression, no death) as of April 23, 2025.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
4 Participants
|
1 Participants
|
Adverse Events
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm 2 Pembrolizumab Only
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 participants at risk
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
|
Arm 2 Pembrolizumab Only
n=1 participants at risk
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • Number of events 6 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Central nervous system necrosis
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Edema cerebral
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
Other adverse events
| Measure |
Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
n=4 participants at risk
3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
|
Arm 2 Pembrolizumab Only
n=1 participants at risk
Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Number of events 3 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • Number of events 6 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
50.0%
2/4 • Number of events 6 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Up to 5 years
|
100.0%
1/1 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/4 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/4 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Investigations
White blood cell decreased
|
50.0%
2/4 • Number of events 2 • Up to 5 years
|
100.0%
1/1 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
3/4 • Number of events 4 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 4 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Paresthesia
|
25.0%
1/4 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Number of events 3 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Infections and infestations
Shingles
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
50.0%
2/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Central nervous system necrosis
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Edema cerebral
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 3 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Investigations
Lymphocyte count increased
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Syncope
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/1 • Up to 5 years
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 3367130031
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place