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Checkpoint Inhibitor
Immunotherapy + Radiation for Lung Cancer
Phase 1
Waitlist Available
Led By Jyoti Malhotra
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have received any prior therapy with immune regulatory molecule (such as targeting OX-40, IDO-1, LAG-3) or anti-CD27 monoclonal antibody (including varlilumab)
Patients must be PD-1/PD-L1 experienced with disease progression documented either on therapy with anti-PD-1/PD-L1 or within 12 weeks of the last dose. Treatment should be initiated at least 4 weeks since last dose of PD-1/PD-L1 targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is to study the side effects of two immunotherapies, atezolizumab and varlilumab, in combination with radiation therapy in treating patients with unresectable, advanced NSCLC.
Who is the study for?
This trial is for adults with advanced, inoperable non-small cell lung cancer who have previously been treated with PD-1/PD-L1 inhibitors and platinum-based chemotherapy. They must not be pregnant or breastfeeding, have a good performance status (ECOG 0 or 1), adequate organ function, no more than 10 metastatic sites, and an expected survival over 3 months. Prior immunotherapy targeting certain immune molecules is excluded.Check my eligibility
What is being tested?
The study tests the combination of atezolizumab and varlilumab with stereotactic body radiation therapy to see how well they work together against lung cancer that has spread. Atezolizumab helps the immune system attack cancer cells while varlilumab may change the immune response to help stop tumor growth.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different organs, infusion-related reactions from receiving drugs through a vein, fatigue, blood disorders like low counts of various types of blood cells which can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not been treated with specific immune-targeting drugs.
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My cancer progressed despite PD-1/PD-L1 therapy, and it's been 4 weeks since my last dose.
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I have less than 10 areas where cancer has spread and am expected to live more than 3 months.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer cannot be removed with surgery.
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My kidney function is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Grade 3 and 4 Toxicity
Secondary outcome measures
To Compare the Frequency of Immune-related Adverse Events (irAEs)
To Determine Objective Response Rate (ORR) of Therapy
To Estimate Clinical Benefit Rate of the Combination
+1 moreOther outcome measures
To Compare Pre- and Post-treatment Tumor Levels of Infiltrating CD3+, CD8+ T-cells
To Compare Pre- and Post-treatment Tumor PD-L1 Expression
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (varlilumab, atezolizumab, SBRT)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,216 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,651 Total Patients Enrolled
Jyoti MalhotraPrincipal Investigator - Rutgers Cancer Institute of New Jersey
Rutgers Cancer Institute of New Jersey
5 Previous Clinical Trials
230 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 2 weeks since my last cancer treatment.I currently have active diverticulitis.I have had a stroke, heart attack, or severe heart symptoms in the last 6 months.I haven't needed strong medication for an autoimmune disease in the last 2 years.I have a specific gene change in my cancer and standard treatments haven't worked.I am a woman who can have children and have a negative pregnancy test.I agree to use two forms of contraception if I'm a sexually active man with a premenopausal partner.I do not have active brain cancer that needs treatment, or if I do, it's stable and treated.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have not been treated with specific immune-targeting drugs.My side effects from previous treatments are mild, except for hair loss, tiredness, skin changes, hormone issues on stable treatment, mild nerve pain, and some hearing loss.I haven't had a severe infection in the last 2 weeks.You have enough white blood cells called neutrophils in your body.Your platelet count is 100,000 or more per microliter of blood.My cancer worsened after platinum-based chemotherapy.My bilirubin levels are within the normal range, even with liver issues.Your liver enzymes (ALT and AST) are not more than 3 times the normal level, unless there is evidence of cancer in the liver, in which case they should not be more than 5 times the normal level.I have had cancer before, but it was either a non-dangerous skin cancer, a localized cancer that did not spread, or any cancer that was completely treated over a year ago.I have less than 10 areas where cancer has spread and am expected to live more than 3 months.My cancer progressed despite PD-1/PD-L1 therapy, and it's been 4 weeks since my last dose.I have a lung lesion suitable for radiation and another measurable lesion, and I agree to biopsies.I have a history of lung conditions but not active lung inflammation.Your hemoglobin level is at least 9.0 grams per deciliter.My cancer can be measured on scans taken within the last 28 days.I have a history of HIV or active hepatitis B or C.I am fully active or restricted in physically strenuous activity but can do light work.My lung cancer cannot be removed with surgery.I agree to use two effective birth control methods during and 12 weeks after the study.My kidney function is within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (varlilumab, atezolizumab, SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently engaged in this clinical research endeavor?
"Unfortunately, this clinical trial is no longer seeking participants. First posted on August 21st 2019 and last updated September 27th 2022, there are other trials available for those with malignant neoplasms (n=1908) or Stereotactic Body Radiation Therapy (n=355)."
Answered by AI
Is this research project unique in its approach?
"Stereotactic Body Radiation Therapy has been a subject of research since 2008, when Hoffmann-La Roche sponsored its initial trial. This Phase 2 drug was approved following the first study with 720 participants and is now being explored in 355 active studies across 1646 cities and 74 countries worldwide."
Answered by AI
Has recruitment for this experiment commenced?
"As indicated by clinicaltrials.gov, the research project initially posted on August 21st 2019 is no longer recruiting participants. Nonetheless, there are currently 2263 other medical experiments that require volunteers at this present moment in time."
Answered by AI
In what cases is Stereotactic Body Radiation Therapy typically employed?
"Stereotactic Body Radiation Therapy is a proven method for treating small cell lung cancer (SCLC) as well as additional malignant neoplasms, non-small cell lung carcinoma, and postoperative conditions."
Answered by AI
Has the FDA authorized Stereotactic Body Radiation Therapy for use?
"Since the trial is still in its preliminary stages, our team at Power has concluded that Stereotactic Body Radiation Therapy's safety can be rated a 1 for now."
Answered by AI
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