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Atezolizumab + Chemoradiation for Small Cell Lung Cancer
Phase 3
Waitlist Available
Led By Kristin A Higgins
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
Aged 18 or above
Had ECOG performance status of 0-2 within 30 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with limited stage small cell lung cancer.
Who is the study for?
This trial is for adults with a confirmed diagnosis of limited stage small cell lung cancer. Participants must have had one cycle of specific chemotherapy, be in good physical condition (ECOG 0-2), and have proper organ function. Pregnant women, those with certain medical conditions or previous treatments like immunotherapy, and individuals not using contraception are excluded.Check my eligibility
What is being tested?
The study is examining the effectiveness of adding Atezolizumab to standard chemoradiation therapy for treating small cell lung cancer. It compares outcomes between patients receiving usual treatment alone versus those also getting this new immunotherapy drug.See study design
What are the potential side effects?
Atezolizumab may cause immune-related reactions, potential liver issues, fatigue, possible infusion-related symptoms, and could interfere with normal organ functions. Chemoradiation can lead to nausea, hair loss, skin changes at the radiation site and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I was mostly active and able to care for myself within the last month.
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I have completed one cycle of platinum/etoposide chemotherapy.
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My cancer was measurable before starting specific chemotherapy.
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I've had a CT scan of my chest and abdomen or an MRI of my abdomen with contrast in the last 60 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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)
Secondary outcome measures
Blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB)
Distant metastases-free survival (DMFS)
Incidence of adverse events
+6 moreOther outcome measures
Patient-reported symptomatic toxicities
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (etoposide, cisplatin, carboplatin, radiation therapy)Experimental Treatment8 Interventions
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
Group II: Arm II (etoposide, cisplatin, carboplatin, radiation therapy)Active Control9 Interventions
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Biospecimen Collection
2004
Completed Phase 2
~1730
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
231 Previous Clinical Trials
100,307 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,608 Total Patients Enrolled
Kristin A HigginsPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver function tests showed AST and ALT levels within a certain range before the start of the study.Your total bilirubin level was not higher than 1.5 times the normal limit before starting the study.I am 18 years old or older.I've had radiation to my chest area that overlaps with new treatment areas.My kidney function, measured by creatinine clearance, is adequate.You have fluid around your lungs or heart that has tested positive for abnormal cells.I have an active hepatitis B or C infection.I had a PET/CT scan for cancer staging within the last 60 days.I had a major heart attack in the last 3 months.Your ANC (absolute neutrophil count) was normal before the pre-registration cycle.Your platelet count was at least 100,000 cells/mm^3 before the pre-registration cycle.I am not pregnant and willing to use contraception if of childbearing potential.I have received an organ from another person.I have a condition that weakens my immune system.I have been cancer-free for at least 2 years from a previous cancer.I have a serious lung condition affecting the tissue and space around the air sacs.I have had more than one round of platinum-based chemotherapy for small cell lung cancer.I had surgery to remove small cell lung cancer.I was mostly active and able to care for myself within the last month.I was diagnosed with early-stage small cell lung cancer in the last 60 days.I have completed one cycle of platinum/etoposide chemotherapy.I have or had inflammatory bowel disease.I haven't taken steroids or immune-weakening drugs in the last 2 weeks.I am HIV-positive, on treatment, and my viral load is undetectable.My cancer was measurable before starting specific chemotherapy.Your hemoglobin level was at least 9 g/dL before starting the study.You had a brain MRI or CT scan with contrast within the last 30 days before joining the study.I take more than 10 mg of prednisone daily for my COPD.I have previously received atezolizumab or another immunotherapy.My cancer has spread to other parts of my body.I've had a CT scan of my chest and abdomen or an MRI of my abdomen with contrast in the last 60 days.I have active tuberculosis.I have a significant liver condition.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 3 months.Women who could still have children need to have a negative pregnancy test within 14 days before joining the study.I have an autoimmune disease.You have a history of a weak immune system from birth.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (etoposide, cisplatin, carboplatin, radiation therapy)
- Group 2: Arm II (etoposide, cisplatin, carboplatin, radiation therapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Does this city have a lot of options for this type of study?
"The University of Wisconsin Hospital and Clinics in Madison, Michigan, McLaren-Greater Lansing in Lansing, South dakota, and Marshfield Clinic Stevens Point Center in Stevens Point, Florida are all locations where this trial is currently being conducted. Additionally, there are 7 other sites."
Answered by AI
Are there any ongoing or previous investigations into Cisplatin?
"Currently, there are 1657 Cisplatin trials underway. 489 of these are Phase 3 clinical trials, which are the most advanced type of study. Most of these trials are based in Shanghai, but there are 86095 locations conducting research on Cisplatin around the world."
Answered by AI
How many people are participating in the clinical trial?
"In order to properly run this study, 545 patients that match the pre-determined inclusion criteria must enroll. These patients can come from several locations, such as University of Wisconsin Hospital and Clinics in Madison, Michigan and McLaren-Greater Lansing in Lansing, South dakota."
Answered by AI
What are the primary therapeutic applications for Cisplatin?
"Cisplatin is most frequently used to treat advanced head and neck cancer, however it can also be an effective medication for sarcoma, and other cancers that have not responded well to other treatments."
Answered by AI
Are you looking for more participants in this clinical trial?
"That is correct. The listing on clinicaltrials.gov indicates that the study is recruiting patients at this time. The posting dates you mentioned are accurate. Additionally, the trial is looking for 545 individuals total, to be recruited from 7 different hospitals or clinics."
Answered by AI
Who else is applying?
What site did they apply to?
Regional Cancer Center-Lee Memorial Health System
Novant Health Cancer Institute - Wilkesboro
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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