Trial Outcomes & Findings for Sequencing of Stereotactic Ablative Body Radiotherapy in Combination With PD-1 Blockade Using Pembrolizumab in Metastatic Non-Small Cell Lung Carcinoma (NCT NCT03307759)

Results Overview

Number of participants with grade 3 treatment related adverse events as determined using CTCAE version 4.03 criteria. Grade 3 treatment-related events are high grade toxicities.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Up to 24 months after commencement of treatment

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	SABR Plus Pembrolizumab SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Overall Study STARTED	5	8
Overall Study COMPLETED	5	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=8 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.	Total n=13 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 10 • n=5 Participants	68 years STANDARD_DEVIATION 8 • n=8 Participants	66 years STANDARD_DEVIATION 9 • n=13 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=8 Participants	5 Participants n=13 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	7 Participants n=8 Participants	8 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Up to 24 months after commencement of treatment

Number of participants with grade 3 treatment related adverse events as determined using CTCAE version 4.03 criteria. Grade 3 treatment-related events are high grade toxicities.

Outcome measures

Outcome measures
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=8 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Adverse Events Measured Using CTCAE Version 4.03	0 participants with G3 TRAEs.	1 participants with G3 TRAEs.

SECONDARY outcome

Timeframe: Assessed up to 24 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=8 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Number of Participants With Overall Response (CR + PR) Assessed Using RECIST 1.1	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Assessed up to 24 months

Per Response Evaluation Criteria In Solid Tumors Criteria (irRECIST) for all lesions and assessed by CT: irComplete Response (CR), Disappearance of all target lesions; irPartial Response (PR), \>=30% decrease in TMTB; Overall Response (OR) = irCR + irPR.

Outcome measures

Outcome measures
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=8 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Number of Participants With Overall Response (irCR + irPR) Assessed Using irRECIST	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Assessed up to 24 months

Population: One patient withdrew consent at cycle 3 from the Pembrolizumab plus SABR Arm, therefore no PET scans were performed and no data available.

Per PERCIST 1.0 Criteria for all lesions and assessed by PET/CT: Complete Metabolic Response (CMR), complete resolution of 18F-FDG uptake; Partial Metabolic Response (PMR), \>=30% decrease in target measurable tumour 18F-FDG SUL peak; Overall Response (OR) = CMR + PMR.

Outcome measures

Outcome measures
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=7 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Number of Participants With Overall Response (CMR + PMC) Assessed Using PERCIST1.0	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Assessed up to 24 months

Population: One patient withdrew consent at cycle 3 from the Pembrolizumab plus SABR ARM, therefore no PET scans were performed.

Per Peter Mac Metabolic Response Criteria In Solid Tumors Criteria (irRECIST) for a lesion and assessed by PET/CT: Complete Metabolic Response (CMRv), FDG activity within tumour site decreased to equal or less than adjacent soft tissue; Partial Metabolic Response (PMRv), any appreciable reduction in intensity of tumour FDG update or in tumour volume; Overall Response (OR) = CMRv + PMRv.

Outcome measures

Outcome measures
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=7 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Number of Participants With Overall Response (CMRv + PMRv) Assessed Using Peter Mac Metabolic Response Criteria	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 months

From randomisation until the date of death from any cause assessed up to the date when the last patient has their 24 months assessment

Outcome measures

Outcome measures
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=8 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Percentage of Participants With Overall Survival	80 percentage of participants Interval 20.0 to 97.0	50 percentage of participants Interval 15.0 to 77.0

SECONDARY outcome

Timeframe: 12 months

From randomisation until the date of first progression or until the date of death from any cause, whichever occurs first, assessed up to the date when the last patient has their 12 months assessment

Outcome measures

Outcome measures
Measure	SABR Plus Pembrolizumab n=5 Participants SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=8 Participants Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Percentage of Participants With Progression Free Survival (PFS)	60 percentage of participants Interval 13.0 to 88.0	43 percentage of participants Interval 10.0 to 73.0

Adverse Events

SABR Plus Pembrolizumab

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Pembrolizumab Plus SABR

Serious events: 3 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	SABR Plus Pembrolizumab n=5 participants at risk SABR (18-20Gy) to 1-3 lesions followed 7 (+/-2) days later by pembrolizumab 200mg every 3 weeks for 24 months.	Pembrolizumab Plus SABR n=8 participants at risk Pembrolizumab 200mg every 3 weeks for 24 months with SABR (18-20Gy) to 1-3 lesions delivered 7 (+/-2) days after first dose of Pembrolizumab.
Musculoskeletal and connective tissue disorders Cortical thinning	20.0% 1/5 • Number of events 1 • Up to 2 years.	0.00% 0/8 • Up to 2 years.
Musculoskeletal and connective tissue disorders Hip pain	20.0% 1/5 • Number of events 1 • Up to 2 years.	0.00% 0/8 • Up to 2 years.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/5 • Up to 2 years.	12.5% 1/8 • Number of events 1 • Up to 2 years.
Cardiac disorders Pericardial effusion	20.0% 1/5 • Number of events 2 • Up to 2 years.	0.00% 0/8 • Up to 2 years.
Cardiac disorders Reaccumulation of pericardial effusion	20.0% 1/5 • Number of events 1 • Up to 2 years.	0.00% 0/8 • Up to 2 years.
Cardiac disorders Non ST elevation myocardial infarct	0.00% 0/5 • Up to 2 years.	12.5% 1/8 • Number of events 1 • Up to 2 years.
General disorders Fatigue	0.00% 0/5 • Up to 2 years.	12.5% 1/8 • Number of events 1 • Up to 2 years.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Development and Operations

Peter MacCallum Cancer Centre

Phone: +61 3 8559 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place