Trial Outcomes & Findings for SBRT Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC) (NCT NCT03050554)

Last Updated: 2024-08-09

Results Overview

Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

6 months

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	SBRT+Avelumab SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles Avelumab: Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles SBRT: SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SBRT Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT+Avelumab n=2 Participants SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles Avelumab: Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles SBRT: SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	2 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: 6 months

Population: The study was terminated due to low enrollment and difficulty with accrual. We accrued 2 patients in 1 year and then Pfizer who was supported the study pulled their funding. So then the study was unfunded and needed to be terminated.

Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 years

Relapse-Free Survival (RFS) is defined as the time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first. Death is considered as an event here.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Locoregional Control (LRC) is defined as the time from starting treatment until local and/or regional relapse is documented

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Overall survival in patients is defined as the time from after completion of SBRT in combination with Avelumab

Outcome measures

Outcome data not reported

Adverse Events

SBRT+Avelumab

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SBRT+Avelumab n=2 participants at risk SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles Avelumab: Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles SBRT: SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
Gastrointestinal disorders Cholecystitis	50.0% 1/2 • Number of events 1 • 24 months

Other adverse events

Other adverse events
Measure	SBRT+Avelumab n=2 participants at risk SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles Avelumab: Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles SBRT: SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
General disorders Fatigue	100.0% 2/2 • Number of events 6 • 24 months
Musculoskeletal and connective tissue disorders Left Rib Pain with Deep Inspiration	50.0% 1/2 • Number of events 1 • 24 months
General disorders Infusion Reaction	50.0% 1/2 • Number of events 5 • 24 months
Respiratory, thoracic and mediastinal disorders Cough	100.0% 2/2 • Number of events 2 • 24 months
Skin and subcutaneous tissue disorders Pruritus	50.0% 1/2 • Number of events 1 • 24 months
Eye disorders Right Eye Pain and Redness	50.0% 1/2 • Number of events 1 • 24 months
Eye disorders Blurred Vision	50.0% 1/2 • Number of events 1 • 24 months
Nervous system disorders Paresthesia	50.0% 1/2 • Number of events 1 • 24 months
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • 24 months
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 1 • 24 months
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • 24 months
Skin and subcutaneous tissue disorders Black Skin Tags	50.0% 1/2 • Number of events 1 • 24 months
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Number of events 1 • 24 months
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • Number of events 2 • 24 months

Additional Information

Dr. Andrew Sharabi

UC San Diego Moores Cancer Center

Phone: 858-534-4808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place