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Radiation + Immunotherapy for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Raid Aljumaily
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
Patient must not have had a prior history of interstitial lung disease or > grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 5) pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of step 2 registration to date of death due to any cause, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new cancer treatment that involves radiation therapy followed by immunotherapy with atezolizumab.
Who is the study for?
This trial is for adults with stage II or III non-small cell lung cancer who've had prior treatments like surgery, chemo, or radiation but not within the last year. They must have proper liver and kidney function, no severe active infections, HIV under control, and can't be pregnant. People with certain blood counts and those who haven't used high-dose steroids recently can join. It's not for those with autoimmune diseases needing treatment in the past 6 months or a history of significant lung disease.Check my eligibility
What is being tested?
The study tests if giving smaller doses of radiation over time (hypofractionated radiation therapy) before atezolizumab—an immune system-boosting drug—can effectively treat non-small cell lung cancer with fewer side effects than standard treatments.See study design
What are the potential side effects?
Possible side effects include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation in organs like lungs or intestines (which could cause coughing or diarrhea), potential liver issues indicated by blood test changes, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be seen on scans taken within the last 28 to 42 days.
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I have never had interstitial lung disease or severe lung inflammation.
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I completed my radiation treatment and received at least 44 Gy within the last 42 days.
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I haven't needed treatment for an autoimmune disease in the last 6 months.
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I haven't taken high doses of steroids in the last 2 weeks.
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I do not have any infections that need treatment.
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My lung cancer has been confirmed by lab tests.
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My lung cancer is stage II or III, and I can care for myself but might not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of step 2 registration to date of death due to any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of step 2 registration to date of death due to any cause, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of grade 3-5 adverse events
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression-free survival
+2 moreSide effects data
From 2022 Phase 2 trial • 107 Patients • NCT0332480280%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (hypofractionated radiation therapy, atezolizumab)Experimental Treatment5 Interventions
RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,287 Total Patients Enrolled
Raid AljumailyPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your AST and ALT liver enzyme levels are not more than 2.5 times the upper limit of normal.Your disease must be able to be treated within the radiation limits set by a local radiation doctor.I do not have an active hepatitis C infection.My cancer can be seen on scans taken within the last 28 to 42 days.My side effects from radiation are mild or gone.I have not received a live vaccine in the last 28 days.Your absolute neutrophil count is at least 1.5 x 10^3/uL within the last 28 days.Your platelet count is at least 100,000 per microliter of blood within the last 28 days.Your total bilirubin level is not more than 1.5 times the upper limit of normal.I have never had interstitial lung disease or severe lung inflammation.I am not pregnant or nursing and agree to use effective birth control during and after the treatment.I have been tested for hepatitis B recently and do not have an active infection.Your bilirubin level is not higher than 1.5 times the normal limit.I had lung cancer treatment but it's been over a year since my last treatment.I completed my radiation treatment and received at least 44 Gy within the last 42 days.Your hemoglobin level is 9 grams per deciliter or higher, as measured within the last 28 days before starting the study.I have no cancer history, except for certain treated cancers or if I've been cancer-free for 3 years.I haven't needed treatment for an autoimmune disease in the last 6 months.My kidney function, measured by creatinine levels or clearance, is within the required range.I haven't taken high doses of steroids in the last 2 weeks.I have recovered from any major surgery side effects, according to my doctor.I had a brain MRI or CT scan with contrast in the last 28 days.Your blood test shows that you have enough infection-fighting white blood cells.I do not have any infections that need treatment.I've had radiation therapy, but not in the area targeted by this study.Your liver enzymes should not be more than 2.5 times the normal limit.Your platelet count is at least 100,000 per microliter within the last 28 days before the study.My lung's ability to transfer gas is at least 50% of what's expected.My lung cancer has been confirmed by lab tests.My lung cancer is stage II or III, and I can care for myself but might not be able to do active work.I have HIV, am on effective treatment, and my last viral load was undetectable.My recent scans show no cancer growth after my last radiation therapy.My kidney function, measured by creatinine levels or clearance, is within the required range.I cannot have surgery for my condition, or my cancer came back 12 months after surgery.Your hemoglobin level is at least 9 grams per deciliter within the past 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (hypofractionated radiation therapy, atezolizumab)
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.
What have the consequences been for individuals utilizing Hypofractionated Radiation Therapy?
"Hypofractionated Radiation Therapy was given a rating of 2 due to the existing evidence in support of its safety, as this is currently an experimental Phase-2 trial with no proof yet concerning efficacy."
Answered by AI
How extensively is this clinical trial represented across the state's healthcare facilities?
"This clinical trial has recruited 100 patients thus far and is currently enrolling at UPMC-Saint Clair Hospital Cancer Center in Kewanee, Illinois CancerCare-Kewanee Clinic in Augusta, as well as Augusta University Medical Center in Chilton. Additionally, there are other sites that have yet to be announced."
Answered by AI
To what ailments is Hypofractionated Radiation Therapy often applied?
"Hypofractionated Radiation Therapy is commonly used to treat small cell lung cancer, however it has also been known to be effective in tackling malignant neoplasms, non-small cell lung carcinoma and postoperative cases."
Answered by AI
How many participants are engaged in the current research project?
"47 individuals, who meet the given criteria for eligibility, are sought out to contribute in this medical study. Participants can be recruited from UPMC-Saint Clair Hospital Cancer Center situated in Kewanee, Illinois or at Illinois CancerCare-Kewanee Clinic located in Augusta, Georgia."
Answered by AI
Is this a pioneering endeavor in the field of medicine?
"Currently, 350 clinical trials are underway to evaluate the efficacy of Hypofractionated Radiation Therapy. These studies span 74 countries and 1646 cities, with Hoffmann-La Roche having initiated the first trial in 2008. This phase 2 drug approval study involved 720 participants and since then an additional 81 investigations have been conducted."
Answered by AI
Can new participants still join this investigation?
"Per information on clinicaltrials.gov, the medical trial is still searching for participants. It was initially posted in June 2020 and its most recent update was issued in November of 2022."
Answered by AI
What precedent has been set with regards to Hypofractionated Radiation Therapy trials?
"Hypofractionated Radiation Therapy first received clinical attention in 2008 at SCRI Tennessee Oncology Chattanooga. Since then, there have been 81 completed trials and 350 more that are actively enrolling participants; Kewanee, Illinois is home to many of these investigations."
Answered by AI
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