Trial Outcomes & Findings for Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC (NCT NCT04081688)
NCT ID: NCT04081688
Last Updated: 2026-02-05
Results Overview
Will include grade 3 and 4 toxicities as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Up to 30 days after the last dose of treatment, an average of a year
Results posted on
2026-02-05
Participant Flow
Participant milestones
| Measure |
Treatment (Varlilumab, Atezolizumab, SBRT)
Patients receive varlilumab IV over 90 minutes and atezolizumab IV over 30-60 minutes every cycle. Cycles repeat every 21 days for up to 1 year (18 cycles) in the absence of disease progression or unacceptable toxicity. Between cycle 1 and 2, patients also receive SBRT.
Atezolizumab 1200 MG in 20 ML Injection: Given IV every 3 weeks (cycle is 21 days)
Stereotactic Body Radiation Therapy: Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)
Varlilumab 3 mg/kg: Given IV every 3 weeks (cycle is 21 days)
|
|---|---|
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Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC
Baseline characteristics by cohort
| Measure |
Treatment (Varlilumab, Atezolizumab, SBRT)
n=15 Participants
Patients receive varlilumab IV over 90 minutes and atezolizumab IV over 30-60 minutes every cycle. Cycles repeat every 21 days for up to 1 year (18 cycles) in the absence of disease progression or unacceptable toxicity. Between cycle 1 and 2, patients also receive SBRT.
Atezolizumab 1200 MG in 20 ML Injection: Given IV every 3 weeks (cycle is 21 days)
Stereotactic Body Radiation Therapy: Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)
Varlilumab 3 mg/kg: Given IV every 3 weeks (cycle is 21 days)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
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Region of Enrollment
United States
|
15 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after the last dose of treatment, an average of a yearWill include grade 3 and 4 toxicities as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
Treatment (Varlilumab, Atezolizumab, SBRT)
n=15 Participants
Patients receive varlilumab IV over 90 minutes and atezolizumab IV over 30-60 minutes every cycle. Cycles repeat every 21 days for up to 1 year (18 cycles) in the absence of disease progression or unacceptable toxicity. Between cycle 1 and 2, patients also receive SBRT.
Atezolizumab 1200 MG in 20 ML Injection: Given IV every 3 weeks (cycle is 21 days)
Stereotactic Body Radiation Therapy: Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)
Varlilumab 3 mg/kg: Given IV every 3 weeks (cycle is 21 days)
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|---|---|
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Number of Participants With Grade 3 and 4 Toxicity
|
2 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment until disease progression/recurrence, assessed up to 1 yearWill be defined as the proportion of all subjected confirmed with an immune-related partial response (irPR) or immune-related complete response (irCR) divided by the number of assigned patients according to immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearWill be defined as the percentage of patients who achieve irCR, irPR, and immune-related stable disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From cycle 1, day 1 (each cycle is 21 days) of treatment until the criteria for disease progression is met as defined by irRECIST or death as a result of any cause, assessed up to 1 yearThe log-rank test will be used to analyze PFS for comparison of treatment effects, i.e., the only covariate that will be used is the treatment arm. Distributions of PFS times will be estimated using the Kaplan- Meier product-limit method. The median PFS times with two-sided 95% confidence intervals will be estimated for each treatment group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after the last dose of treatmentirAE's are defined as any treatment-related AE that is inflammatory in nature, consistent with the mechanism of action of immunotherapy and generally medically manageable with topical and/or systemic immunosuppressants.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to cycle 2, day 8 (each cycle is 21 days)Will be assessed by immunohistochemistry (IHC) and will score the percentage of cells staining positively for PD-L1 incrementally. Scoring will be performed for the percentage of malignant tumor cells and for the percentage of nonmalignant inflammatory cell compartment that express PD-L1, separately.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to cycle 2, day 8 (each cycle is 21 days)Will be assessed by IHC staining to identify tumor infiltrating lymphocytes at the tumor stroma interface.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Varlilumab, Atezolizumab, SBRT)
Serious events: 8 serious events
Other events: 12 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Treatment (Varlilumab, Atezolizumab, SBRT)
n=15 participants at risk
Patients receive varlilumab IV over 90 minutes and atezolizumab IV over 30-60 minutes every cycle. Cycles repeat every 21 days for up to 1 year (18 cycles) in the absence of disease progression or unacceptable toxicity. Between cycle 1 and 2, patients also receive SBRT.
Atezolizumab 1200 MG in 20 ML Injection: Given IV every 3 weeks (cycle is 21 days)
Stereotactic Body Radiation Therapy: Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)
Varlilumab 3 mg/kg: Given IV every 3 weeks (cycle is 21 days)
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|---|---|
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Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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General disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Injury, poisoning and procedural complications
Lung infestations
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20.0%
3/15 • Number of events 3 • Up to 30 days after the last dose of treatment, an average of a year.
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Psychiatric disorders
Confusion
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6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Renal and urinary disorders
Acute kidney injury
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6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
4/15 • Number of events 4 • Up to 30 days after the last dose of treatment, an average of a year.
|
Other adverse events
| Measure |
Treatment (Varlilumab, Atezolizumab, SBRT)
n=15 participants at risk
Patients receive varlilumab IV over 90 minutes and atezolizumab IV over 30-60 minutes every cycle. Cycles repeat every 21 days for up to 1 year (18 cycles) in the absence of disease progression or unacceptable toxicity. Between cycle 1 and 2, patients also receive SBRT.
Atezolizumab 1200 MG in 20 ML Injection: Given IV every 3 weeks (cycle is 21 days)
Stereotactic Body Radiation Therapy: Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)
Varlilumab 3 mg/kg: Given IV every 3 weeks (cycle is 21 days)
|
|---|---|
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Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Number of events 7 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Investigations
Lymphocyte count decreased
|
33.3%
5/15 • Number of events 5 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
3/15 • Number of events 3 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Number of events 2 • Up to 30 days after the last dose of treatment, an average of a year.
|
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General disorders
Pain
|
13.3%
2/15 • Number of events 2 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
40.0%
6/15 • Number of events 10 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Infections and infestations
Infections and infestations
|
26.7%
4/15 • Number of events 4 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Nervous system disorders
Nervous system disorders
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Psychiatric disorders
Confusion
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Investigations
Alkaline phosphatase increased
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6.7%
1/15 • Number of events 2 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Investigations
Aspartate aminotransferase increased
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6.7%
1/15 • Number of events 2 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Investigations
Lipase increased
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6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
|
Investigations
White blood cell decreased
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
13.3%
2/15 • Number of events 2 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2 • Up to 30 days after the last dose of treatment, an average of a year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Number of events 2 • Up to 30 days after the last dose of treatment, an average of a year.
|
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General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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General disorders
Fever
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Vascular disorders
Vascular disorders
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6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Nervous system disorders
Headache
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6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
|
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Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • Up to 30 days after the last dose of treatment, an average of a year.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place