Trial Outcomes & Findings for Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer (NCT NCT03035890)

Last Updated: 2025-04-01

Results Overview

Time to Best Overall Response is measured in months from the start of treatment until the best response is achieved. Both RECIST v1.1 and irRC criteria will be used. RECIST Criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD. Progressive Disease (PD): ≥20% increase in the sum of the diameters of target lesions or appearance of new lesions. irRC Criteria: Complete Response (irCR): Disappearance of all lesions in two consecutive observations ≥4 weeks apart. Partial Response (irPR): ≥50% decrease in tumor burden compared with baseline in two observations ≥4 weeks apart. Stable Disease (irSD): Neither sufficient decrease for irPR nor sufficient increase for irPD. Progressive Disease (irPD): ≥25% increase in tumor burden compared with nadir in two consecutive observations ≥4 weeks apart.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

From the start of treatment until disease progression up to 2 years.

Results posted on

2025-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation Therapy + Immunotherapy 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Overall Study STARTED	35
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation Therapy + Immunotherapy 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Overall Study Death	1

Baseline Characteristics

Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy + Immunotherapy n=35 Participants 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of treatment until disease progression up to 2 years.

Outcome measures

Outcome measures
Measure	Radiation Therapy + Immunotherapy n=34 Participants 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Time to Best Overall Response	14 months Interval 5.4 to 23.5

SECONDARY outcome

Timeframe: From the start of treatment until the date of documented progression or death assessed up to 2 years

The duration of time from start of treatment to time of progression or death, whichever occurs first. For those patients with a CR or PR, the reference for progressive disease is the smallest measurements recorded since the treatment started. RECIST version 1.1 will be used to assess the local response of irradiated lesions only, taking as reference the baseline largest diameter: Complete Response (CR) - Disappearance of the irradiated lesion Partial Response (PR) - \> 30% decrease in the single largest diameter of the irradiated lesion Stable Disease (SD) - Neither sufficient decrease in diameter to qualify as PR nor sufficient increase in diameter to qualify as PD Progressive Disease (PD) - \> 20% increase in the single largest diameter of the irradiated lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm).

Outcome measures

Outcome measures
Measure	Radiation Therapy + Immunotherapy n=35 Participants 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Time to Progression Free Survival	6.9 Months Interval 4.3 to 26.0

SECONDARY outcome

Timeframe: From the start of treatment until the date date of death, or the last follow up date on which the participant was reported alive, assessed up to 2 years

Amount of time from treatment until death, reported via follow up visit or phone call.

Outcome measures

Outcome measures
Measure	Radiation Therapy + Immunotherapy n=35 Participants 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Overall Survival	15 months Interval 11.0 to 40.0

Adverse Events

Radiation Therapy + Immunotherapy

Serious events: 25 serious events

Other events: 32 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Radiation Therapy + Immunotherapy n=35 participants at risk 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Atrial fibrillation	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Constrictive pericarditis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Myocardial infarction	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Pericardial effusion	8.6% 3/35 • Number of events 3 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Pericardial tamponade	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Pericarditis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Sinus bradycardia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Endocrine disorders Adrenal insufficiency	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Abdominal pain	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Colitis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Constipation	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Duodenal hemorrhage	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Duodenal ulcer	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Dysphagia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Nausea	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders Fever	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders General disorders and administration site conditions - Other, specify	14.3% 5/35 • Number of events 5 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders Pain	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Infections and infestations - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Lung infection	14.3% 5/35 • Number of events 5 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Sepsis	11.4% 4/35 • Number of events 4 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Skin infection	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Injury, poisoning and procedural complications Fall	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Alanine aminotransferase increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Alkaline phosphatase increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Aspartate aminotransferase increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Creatinine increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations GGT increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Platelet count decreased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hypernatremia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hypoglycemia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hypokalemia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Back pain	8.6% 3/35 • Number of events 3 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Nervous system disorders Encephalopathy	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Renal and urinary disorders Urinary incontinence	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.4% 4/35 • Number of events 4 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Hypoxia	8.6% 3/35 • Number of events 3 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Vascular disorders Hypotension	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Vascular disorders Thromboembolic event	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Vascular disorders Vascular disorders - Other, specify	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.

Other adverse events

Other adverse events
Measure	Radiation Therapy + Immunotherapy n=35 participants at risk 3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent Radiation: Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy) Immuno-Therapeutic Agent: Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	37.1% 13/35 • Number of events 13 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Atrial fibrillation	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Constrictive pericarditis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Myocardial infarction	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Pericardial effusion	17.1% 6/35 • Number of events 6 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Pericardial tamponade	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Pericarditis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Cardiac disorders Sinus bradycardia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Endocrine disorders Adrenal insufficiency	11.4% 4/35 • Number of events 4 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Endocrine disorders Hypothyroidism	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Eye disorders Blurred vision	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Abdominal pain	14.3% 5/35 • Number of events 5 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Bloating	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Colitis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Constipation	11.4% 4/35 • Number of events 4 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Diarrhea	14.3% 5/35 • Number of events 5 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Duodenal hemorrhage	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Duodenal ulcer	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Dysphagia	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Nausea	20.0% 7/35 • Number of events 7 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Pancreatitis	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Gastrointestinal disorders Vomiting	8.6% 3/35 • Number of events 3 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders Death NOS	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders Fatigue	20.0% 7/35 • Number of events 7 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders Fever	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders General disorders and administration site conditions - Other, specify	11.4% 4/35 • Number of events 4 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders Non-cardiac chest pain	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
General disorders Pain	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Bronchial infection	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Lung infection	22.9% 8/35 • Number of events 8 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Sepsis	17.1% 6/35 • Number of events 6 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Infections and infestations Urinary tract infection	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Injury, poisoning and procedural complications Dermatitis radiation	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Injury, poisoning and procedural complications Fall	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Alanine aminotransferase increased	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Alkaline phosphatase increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Aspartate aminotransferase increased	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Blood bilirubin increased	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Creatinine increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations GGT increased	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Investigations - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Neutrophil count decreased	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Platelet count decreased	25.7% 9/35 • Number of events 9 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Investigations Weight loss	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Anorexia	8.6% 3/35 • Number of events 3 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hypernatremia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hypoglycemia	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hypokalemia	20.0% 7/35 • Number of events 7 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hypomagnesemia	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Metabolism and nutrition disorders Hyponatremia	11.4% 4/35 • Number of events 4 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Back pain	22.9% 8/35 • Number of events 8 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Bone pain	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Buttock pain	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Flank pain	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Nervous system disorders Dysgeusia	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Nervous system disorders Encephalopathy	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Nervous system disorders Headache	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Nervous system disorders Syncope	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Psychiatric disorders Anxiety	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Renal and urinary disorders Acute kidney injury	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Renal and urinary disorders Urinary incontinence	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 5/35 • Number of events 5 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 10/35 • Number of events 10 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 7/35 • Number of events 7 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 7/35 • Number of events 7 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.4% 4/35 • Number of events 4 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	14.3% 5/35 • Number of events 5 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Skin and subcutaneous tissue disorders Rash acneiform	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.9% 1/35 • Number of events 1 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	8.6% 3/35 • Number of events 3 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Vascular disorders Hypotension	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Vascular disorders Thromboembolic event	8.6% 3/35 • Number of events 3 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.
Vascular disorders Vascular disorders - Other, specify	5.7% 2/35 • Number of events 2 • 2 years Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during hospitalization, follow up or by chart review.

Additional Information

Tara Riddle

WVCTSI

Phone: 304-581-1829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place