Trial Outcomes & Findings for Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC (NCT NCT05691829)
NCT ID: NCT05691829
Last Updated: 2025-07-29
Results Overview
Defined as the best response recorded from the start of the study treatment until the end of treatment Cycle 4, either Complete Response or Partial Response. A CR is defined as the disappearance of all target lesions (TLs) and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm. A PR is defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to Week 12 (End of Cycle 4 - each cycle is 21 days)
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
Untreated Patients With Stage IV NSCLC
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Untreated Patients With Stage IV NSCLC
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Eligibility criteria not met
|
3
|
Baseline Characteristics
Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC
Baseline characteristics by cohort
| Measure |
Untreated Patients With Stage IV NSCLC
n=14 Participants
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Age, Continuous
|
80 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12 (End of Cycle 4 - each cycle is 21 days)Population: 1 participant did not start treatment
Defined as the best response recorded from the start of the study treatment until the end of treatment Cycle 4, either Complete Response or Partial Response. A CR is defined as the disappearance of all target lesions (TLs) and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm. A PR is defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD.
Outcome measures
| Measure |
Untreated Patients With Stage IV NSCLC
n=13 Participants
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Percent of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by End of Treatment Cycle 4
|
30.77 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment until the first documented and confirmed progression of disease, death, date last follow-up, or end of study; assessed up to 81 weeksPopulation: 1 participant did not start treatment
PFS is defined as the time from initiation of study drug post-radiation, until the first documented, confirmed progression of disease or death.
Outcome measures
| Measure |
Untreated Patients With Stage IV NSCLC
n=13 Participants
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Progression-Free Survival (PFS) at Final Follow-Up
|
42.86 weeks
Interval 6.43 to 80.86
|
SECONDARY outcome
Timeframe: From enrollment until the first documented and confirmed progression of disease, death, date last follow-up, or end of study; assessed up to 81 weeksPopulation: 1 participant did not start treatment
OS is defined as the time (in weeks) to death from the start of drug therapy.
Outcome measures
| Measure |
Untreated Patients With Stage IV NSCLC
n=13 Participants
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Overall Survival (OS) at Final Follow-Up
|
51.57 weeks
Interval 6.43 to 80.86
|
SECONDARY outcome
Timeframe: Week 52Population: 1 participant did not start treatment
An objective response (Complete Response or Partial Response) is defined as lasting continuously for 6 months and starting any time within 12 months of initiating therapy. A CR is defined as the disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm. A PR is defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD.
Outcome measures
| Measure |
Untreated Patients With Stage IV NSCLC
n=13 Participants
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Percentage of Participants With an Objective Response
|
38.46 percentage of participants
|
Adverse Events
Untreated Patients With Stage IV NSCLC
Serious events: 9 serious events
Other events: 13 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Untreated Patients With Stage IV NSCLC
n=14 participants at risk
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Nervous system disorders
Adrenal Insufficiency
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Vascular disorders
Arterial Thomboembolism
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
General disorders
Disease Progression
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
4/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Cardiac disorders
Heart Failure
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Injury, poisoning and procedural complications
Injury, Other
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Nervous system disorders
Intracranial Hemorrhage
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection: Pneumonia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Massive Hemoptysis
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Injury, poisoning and procedural complications
Multiple Fractures From Trauma
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Renal and urinary disorders
Urinary Tract Infection
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
Other adverse events
| Measure |
Untreated Patients With Stage IV NSCLC
n=14 participants at risk
Participants will receive radiation in concert with starting chemotherapy with pembrolizumab for up to 6 cycles (18 weeks), followed by continued treatment with pembrolizumab (standard of care). Patients will be followed for 1 year following the completion of the core study period of 6 cycles.
Pembrolizumab: Pembrolizumab 200mg solution administered intravenously every 3 weeks for 6 cycles followed by maintenance therapy until progression of disease or unacceptable toxicity (standard of care). Administered alongside chemotherapy.
Radiation: One-time, up-front radiation delivered at up to five metastatic subsites at a 4 Gy x 5 radiation dose fractionation schedule. Radiation will be delivered within five days before or after initiation of first cycle of pembrolizumab treatment. Radiation modality and technique will be determined at the discretion of the treating radiation oncologist.
Chemotherapy: Administered alongside pembrolizumab every 3 weeks for 6 cycles per institutional standard of care. For non-squamous, the standard chemotherapy option of choice is carboplatin and pemetrexed. For squamous cell carcinoma, the chemotherapy used would be carboplatin and paclitaxel or nab-paclitaxel
|
|---|---|
|
Gastrointestinal disorders
Intermittent Diarrhea
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Intermittent Nausea
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Knee Pain / Gout
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Nervous system disorders
Left Arm Paresthesia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Muscle Cramps
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Weakness
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Investigations
Lymphocyte Count Decreased
|
28.6%
4/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Other Respiratory Symptom
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Injury, poisoning and procedural complications
Pain (Groin, Right-Sided, Post-Operative)
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Injury, poisoning and procedural complications
Pain (Multiple Bone Fractures)
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity (B/L Back Thighs)
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain, R Foot
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Skin and subcutaneous tissue disorders
Palmar
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Skin and subcutaneous tissue disorders
Papulopustular Rash
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Nervous system disorders
Paresthesia (Right Foot)
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Eye disorders
Periorbital Edema
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Nervous system disorders
Peripheral Neuropathy
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin, Other: Wounds From Trauma
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Blood and lymphatic system disorders
ANC Decreased
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Appetite
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain, Non-Cardiac
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Chest Wall Pain (Non-Cardiac: ribcage)
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Covid 19 Virus
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Investigations
Creatinine Increased
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Dry Mouth
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
General disorders
Edema Limbs
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Skin and subcutaneous tissue disorders
Erythematous Rash
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
General disorders
Fatigue
|
35.7%
5/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
General disorders
Fever
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Infections and infestations
Herpes Simplex Virus
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hoarseness
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
3/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Psychiatric disorders
Insomnia
|
21.4%
3/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Investigations
Platelet Count Decreased
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.4%
3/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Eye disorders
Purulent Tear Discharge
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash On Leg
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Cardiac disorders
Sinus Tachycardia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Vascular disorders
Thrombolic Event
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Renal and urinary disorders
Urinary Frequency
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Infections and infestations
Vaginal Infection
|
7.1%
1/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Investigations
WBC Decreased
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
|
Investigations
Weight Loss
|
14.3%
2/14 • AE monitoring: from time of consent through 30 days post treatment (up to 22 weeks) All cause mortality monitoring: from time of consent until End of Study (up to 81 weeks)
Investigators reviewed adverse events at every study visit (every 3 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place