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Checkpoint Inhibitor
Radiation Therapy + Atezolizumab for Small Cell Lung Cancer
Phase 2 & 3
Recruiting
Led By Quynh-Nhu Nguyen
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
Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases
Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 6 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab (a monoclonal antibody) versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage).
Eligible Conditions
- Extensive-stage Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with small cell lung cancer that has spread extensively throughout your body, either in the primary or metastatic sites.
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You have a maximum of three visible liver metastases that can be measured using standard imaging techniques, without any signs of worsening of the disease.
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If you have fluid buildup around your lungs (pleural effusion), you can only participate in the trial if the fluid does not show any signs of cancer cells or is too small to be tested.
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You need to have a special type of brain scan called an MRI or CT with contrast.
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You need to have a medical imaging test of your chest, abdomen, and pelvis or your whole body after completing four cycles of chemotherapy but before joining the study.
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Your blood test showed that you have enough infection-fighting white blood cells (ANC count) within the last 14 days before the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS) (Phase III)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Incidence of adverse events
OS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease
Neoplasms
+3 moreOther outcome measures
Tumor burden
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (atezolizumab, radiation therapy)Experimental Treatment6 Interventions
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Group II: Arm I (atezolizumab)Active Control5 Interventions
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Atezolizumab
2016
Completed Phase 3
~6040
Biospecimen Collection
2004
Completed Phase 1
~1540
Computed Tomography
2017
Completed Phase 2
~2890
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,487 Previous Clinical Trials
41,266,614 Total Patients Enrolled
NRG OncologyOTHER
226 Previous Clinical Trials
99,780 Total Patients Enrolled
Quynh-Nhu NguyenPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
278 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another form of cancer that could affect the safety or effectiveness of the study drug atezolizumab or radiation treatment.You have already received radiation therapy in your chest area that overlaps with the current trial's radiation fields, unless the overlapping areas meet safe dosage levels for normal tissues.You can still participate in the trial if you have eczema, psoriasis, lichen simplex chronicus, or vitiligo, as long as you are not currently experiencing a flare-up and have not taken medication to suppress your immune system within the past year.You have a serious health condition that is currently active.You have any medical condition or abnormal lab result that may prevent you from safely participating in the study or could interfere with the accuracy of the study results.You have had an organ transplant from another person.You have a severe form of lung disease called COPD and take more than 10 mg of prednisone daily or an equivalent medication. However, if you only use inhaled corticosteroids, you are not excluded from the study.You are currently breastfeeding and do not want to stop during the study.You must have received at least 3 cycles of a drug combination called E/P, along with atezolizumab. If you were unable to receive all cycles of E/P combined with atezolizumab, you may have had one cycle of E/P without atezolizumab.If a metastatic site is causing pain or risk of fracture, radiation therapy is allowed.Your cancer has spread extensively, with more than 3 tumors in your liver or more than 10 visible tumors after treatment. Each visible bone tumor counts as one site.You have an ongoing autoimmune disease such as lupus, rheumatoid arthritis, or multiple sclerosis.You must receive at least three cycles of E/P (a specific type of chemotherapy) combined with atezolizumab (an immunotherapy drug). If you cannot receive atezolizumab during all cycles of treatment, you may receive one cycle of E/P without atezolizumab.You must be able to perform daily activities without significant difficulty or assistance.Your blood test showed that you have enough infection-fighting white blood cells (ANC count) within the last 14 days before the study.You have been diagnosed with small cell lung cancer that has spread extensively throughout your body, either in the primary or metastatic sites.You have had a positive response or stable disease after receiving a combination of etoposide, platinum, and atezolizumab for 4-6 cycles. You must be randomized within a specific timeframe after completing this treatment.You have a maximum of three visible liver metastases that can be measured using standard imaging techniques, without any signs of worsening of the disease.If you have fluid buildup around your lungs (pleural effusion), you can only participate in the trial if the fluid does not show any signs of cancer cells or is too small to be tested.You had a physical exam within two weeks before registering for the trial.You need to have a special type of brain scan called an MRI or CT with contrast.You need to have a medical imaging test of your chest, abdomen, and pelvis or your whole body after completing four cycles of chemotherapy but before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (atezolizumab, radiation therapy)
- Group 2: Arm I (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.
Is this study mainly taking place in North American hospitals?
"Presently, this clinical trial is looking for patients from a pool of 100 different enrolment sites. Some of these sites are located in Danville, Des Moines, and Brighton. There are also many other sites which are closer to where potential patients might live. This is to reduce the amount of travel required, should somebody choose to enroll in the trial."
Answered by AI
Have other companies conducted similar research projects?
"Since its inception in 2008, Radiation Therapy has been the focus of many studies. The first was sponsored by Genentech, Inc and was published in 2008. After the success of the initial trial, which recruited 720 participants, Radiation Therapy received Phase 2 approval. Currently, there are 361 active trials being conducted in 1668 cities and 74 countries."
Answered by AI
What types of cancer does Radiation Therapy typically target?
"Radiation therapy can be used to target small cell lung cancer specifically, but it is also a viable treatment option for non-small cell lung carcinoma and postoperative patients."
Answered by AI
What other scientific papers have been published on the topic of Radiation Therapy?
"Radiation therapy was first studied in 2008 at National Cheng Kung Uni Hospital. There have been a total of 181 completed trials since then. Danville, Pennsylvania is currently conducting a significant number of the 361 live clinical trials."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Decatur Memorial Hospital
University of Cincinnati Cancer Center-UC Medical Center
MetroHealth Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've had chemotherapy, immunotherapy and whole brain radiation therapy but feel that I need more in my hope to live longer.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- University of Cincinnati Cancer Center-UC Medical Center: < 48 hours
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