A Phase 1/2 interventional study of Avelumab and SBRT in Early Stage Non-Small Cell Lung Cancer, sponsored by Andrew Sharabi. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Andrew Sharabi · Phase 1/2, Interventional, and Treatment
The purpose of the study is to determine whether avelumab has an effect on cancer and body in combination with SBRT, a standard treatment for early stage non-small cell lung cancer (NSCLC).
Avelumab is considered experimental because it is not approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be stimulated, allowing it to more effectively recognize and attack the cancer.
Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting to deliver a high dose of radiation to the tumor over a short period of time. A positioning cushion such as Vac-lok will be used during radiation treatment that is custom made. This custom mold forms to the contours of the subjects body to allow for proper positioning comfort and stability.
This is a single arm open label Phase I/II study that will consist of two parts. In Phase I, investigators will assess the safety and tolerability of SBRT combined with Avelumab. In Phase II, investigators will determine whether SBRT combined with Avelumab improves relapse free survival. Subjects with Stage I NSCLC who are not undergoing surgical resection will be candidates for enrollment. Subjects will receive definitive stereotactic body radiation (SBRT) in 4-5 fractions combined with concurrent and adjuvant Avelumab at 10mg/kg for a total of 6 cycles. Subjects will be evaluated for safety as measured by the occurrence of adverse events, serious adverse events, and laboratory abnormalities. Three blood draws will be obtained to analyze anti-tumor immune responses and immune correlates.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 2 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Significant acute or chronic infections including:
Active autoimmune disease
Current use of immunosuppressive medication, EXCEPT for the following:
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
Drug: Avelumab · Radiation: SBRT
Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles
Also known as: Bavencio
SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
Also known as: Stereotactic Body Radiation Therapy
Adverse Events
Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).
Time frame: 6 months
Relapse Free Survival (RFS)
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.
Time frame: 3 years
Loco-regional Control (LRC)
Locoregional Control (LRC) is defined as the time from starting treatment until local and/or regional relapse is documented
Time frame: 3 years
Overall Survival in Patients After Completion of SBRT in Combination With Avelumab
Overall survival in patients is defined as the time from after completion of SBRT in combination with Avelumab
Time frame: 3 years
| Milestone | SBRT+Avelumab |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Locoregional Control (LRC) is defined as the time from starting treatment until local and/or regional relapse is documented
No measurements were reported for this outcome.
Overall survival in patients is defined as the time from after completion of SBRT in combination with Avelumab
No measurements were reported for this outcome.
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SBRT+Avelumab | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Event | SBRT+Avelumab |
|---|---|
| CholecystitisGastrointestinal disorders | 1/2 |
| Event | SBRT+Avelumab |
|---|---|
| FatigueGeneral disorders | 2/2 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/2 |
| Left Rib Pain with Deep InspirationMusculoskeletal and connective tissue disorders | 1/2 |
| Infusion ReactionGeneral disorders | 1/2 |
| PruritusSkin and subcutaneous tissue disorders | 1/2 |
| Right Eye Pain and RednessEye disorders | 1/2 |
| Blurred VisionEye disorders | 1/2 |
| ParesthesiaNervous system disorders | 1/2 |
| NauseaGastrointestinal disorders | 1/2 |
| VomitingGastrointestinal disorders | 1/2 |
| Age, Categorical(Participants) | SBRT+Avelumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | SBRT+Avelumab |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | SBRT+Avelumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Oct 2017 to primary completion in Oct 2019, 23 months.
Results were first posted in Aug 2024, 4 years 10 months after primary completion.
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Studies of the drug tested here: Avelumab