Trial Outcomes & Findings for SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer (NCT NCT02581787)
NCT ID: NCT02581787
Last Updated: 2024-03-27
Results Overview
DLT is defined as CTCAE grade 3 or higher radiation pneumonitis or bronchopulmonary hemorrhage.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2024-03-27
Participant Flow
28 participants signed consent; 24 were allocated to treatment.
Participant milestones
| Measure |
(Phase 1) Fresolimumab 3 mg/kg
Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
(Phase 1) Fresolimumab 1 mg/kg
Patients receive fresolimumab 1 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
(Phase 2) Fresolimumab
Fresolimumab will be administered IV at the dose selected in the preceding Phase 1 on Days 1, 15 and 36 and SABR will be administered in 4 fractions between Days 8 and 12.
|
|---|---|---|---|
|
Phase 1
STARTED
|
5
|
0
|
0
|
|
Phase 1
Received Treatment
|
5
|
0
|
0
|
|
Phase 1
Completed Radiation
|
4
|
0
|
0
|
|
Phase 1
Completed FRESO Treatments
|
4
|
0
|
0
|
|
Phase 1
Completed 12-month Follow-up Visit
|
5
|
0
|
0
|
|
Phase 1
COMPLETED
|
4
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
1
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
19
|
|
Phase 2
Received Treatment
|
0
|
0
|
18
|
|
Phase 2
Completed Radiation
|
0
|
0
|
17
|
|
Phase 2
Completed FRESO Treatments
|
0
|
0
|
13
|
|
Phase 2
Completed 12-month Follow-up Visit
|
0
|
0
|
13
|
|
Phase 2
COMPLETED
|
0
|
0
|
12
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
(Phase 1) Fresolimumab 3 mg/kg
n=5 Participants
Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
(Phase 2) Fresolimumab
n=19 Participants
Fresolimumab will be administered IV at the dose selected in the preceding Phase 1 on Days 1, 15 and 36 and SABR will be administered in 4 fractions between Days 8 and 12.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-59 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysDLT is defined as CTCAE grade 3 or higher radiation pneumonitis or bronchopulmonary hemorrhage.
Outcome measures
| Measure |
(Phase 1) Fresolimumab 3 mg/kg
n=5 Participants
Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
|---|---|
|
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) of Fresolimumab When Combined With SABR (Phase I)
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients who met criteria to be considered for endpoint analysis.
Presence of radiation induced pulmonary fibrosis is defined as presence of a moderate-to-severe level of fibrosis. This outcome is primary in phase 2 patients.
Outcome measures
| Measure |
(Phase 1) Fresolimumab 3 mg/kg
n=15 Participants
Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
|---|---|
|
Number of Participants With Late Radiation Induced Fibrosis
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPresence of radiation induced pulmonary fibrosis is defined as presence of a moderate-to-severe level of fibrosis. This outcome is secondary for phase 1 patients.
Outcome measures
| Measure |
(Phase 1) Fresolimumab 3 mg/kg
n=5 Participants
Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
|---|---|
|
Number of Participants With Late Radiation Induced Fibrosis (Phase 1 Patients)
|
1 Participants
|
Adverse Events
(Phase 1) Fresolimumab 3 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 4 deaths
(Phase 2) Fresolimumab
Serious events: 6 serious events
Other events: 15 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
(Phase 1) Fresolimumab 3 mg/kg
n=5 participants at risk
Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
(Phase 2) Fresolimumab
n=19 participants at risk
Fresolimumab will be administered IV at the dose selected in the preceding Phase 1 on Days 1, 15 and 36 and SABR will be administered in 4 fractions between Days 8 and 12.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/5 • 12 months
|
10.5%
2/19 • 12 months
|
|
Cardiac disorders
av block
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
upper gastrointestinal hemorrhage
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Infections and infestations
lung infection
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Infections and infestations
sepsis
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Nervous system disorders
encephalopathy
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Nervous system disorders
mental changes status
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/5 • 12 months
|
15.8%
3/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
Other adverse events
| Measure |
(Phase 1) Fresolimumab 3 mg/kg
n=5 participants at risk
Patients receive fresolimumab 3 mg/kg IV on days 1, 15, and 36 and undergo SABR in 4 fractions between days 8 and 12.
|
(Phase 2) Fresolimumab
n=19 participants at risk
Fresolimumab will be administered IV at the dose selected in the preceding Phase 1 on Days 1, 15 and 36 and SABR will be administered in 4 fractions between Days 8 and 12.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/5 • 12 months
|
26.3%
5/19 • 12 months
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Cardiac disorders
chest pain - cardiac
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
esophagitis
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
abdominal pain
|
20.0%
1/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
mucositis oral
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Gastrointestinal disorders
nausea
|
40.0%
2/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
General disorders
edema limbs
|
0.00%
0/5 • 12 months
|
15.8%
3/19 • 12 months
|
|
General disorders
fatigue
|
40.0%
2/5 • 12 months
|
31.6%
6/19 • 12 months
|
|
General disorders
infusion related reaction
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Infections and infestations
r cheek skin lesion
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Infections and infestations
rash pustular
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Injury, poisoning and procedural complications
dermatitis radiation
|
0.00%
0/5 • 12 months
|
15.8%
3/19 • 12 months
|
|
Investigations
creatinine increased
|
0.00%
0/5 • 12 months
|
10.5%
2/19 • 12 months
|
|
Investigations
weight loss
|
0.00%
0/5 • 12 months
|
10.5%
2/19 • 12 months
|
|
Investigations
lymphocyte count decreased
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Investigations
wbc decreased
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Investigations
lymphocyte count decrease
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Metabolism and nutrition disorders
anorexia
|
20.0%
1/5 • 12 months
|
10.5%
2/19 • 12 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/5 • 12 months
|
42.1%
8/19 • 12 months
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Nervous system disorders
headache
|
0.00%
0/5 • 12 months
|
21.1%
4/19 • 12 months
|
|
Nervous system disorders
dizziness
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Nervous system disorders
presyncope
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
20.0%
1/5 • 12 months
|
36.8%
7/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
20.0%
1/5 • 12 months
|
21.1%
4/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchial obstruction (copd)
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
20.0%
1/5 • 12 months
|
10.5%
2/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary fibrosis
|
0.00%
0/5 • 12 months
|
15.8%
3/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/5 • 12 months
|
10.5%
2/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
skin atrophy
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Vascular disorders
hypertension
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Vascular disorders
hypotension
|
0.00%
0/5 • 12 months
|
5.3%
1/19 • 12 months
|
|
Infections and infestations
papulopustular rash
|
20.0%
1/5 • 12 months
|
0.00%
0/19 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
20.0%
1/5 • 12 months
|
0.00%
0/19 • 12 months
|
|
Skin and subcutaneous tissue disorders
skin hyperpigmentation
|
20.0%
1/5 • 12 months
|
0.00%
0/19 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place