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Chemotherapy
Adaptive Radiation + Pembrolizumab for Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Evan Osmundson, MD, PhD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new way to give radiation therapy for stage IV lung cancer that may be more effective than the standard treatment.
Who is the study for?
Adults (18+) with stage IV lung cancer and limited metastases, who can handle the physical demands of the trial (ECOG 0-2). They must have tumor material for PD-L1 testing, managed brain metastases if present, and adequate organ function. Prior immunotherapy is allowed; however, they should not be pregnant or breastfeeding and must use effective contraception.Check my eligibility
What is being tested?
The trial tests split-course adaptive radiation therapy combined with pembrolizumab immunotherapy, with or without chemotherapy drugs like carboplatin. The treatment aims to tailor radiation precisely to patient response while enhancing immune system attack on cancer cells.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation such as skin irritation and fatigue; immune-related issues like inflammation in organs due to pembrolizumab; and chemotherapy effects including nausea, hair loss, blood cell count changes leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response rate
Incidence of adverse events
Secondary outcome measures
Neoplasm Metastasis
Overall survival
Progression free survival (PFS)
+1 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: Arm XI (nivolumab, ipilumumab, radiation)Experimental Treatment8 Interventions
Patients receive ipilmumab every 6 weeks and nivolumab every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group II: Arm X (cemiplimab-rwlc, radiation)Experimental Treatment7 Interventions
Patients receive cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions.
All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group III: Arm VIII (pembrolizumab, radiation)Experimental Treatment7 Interventions
Patients receive pembrolizumab on day 1 of each cycle. Cycles repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group IV: Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)Experimental Treatment10 Interventions
Patients receive carboplatin, paclitaxel, and cemiplimab-rwlc on day 1 of each cycle. Treatment repeats every 3 weeks for 4 up to cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. Patients then receive cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group V: Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)Experimental Treatment9 Interventions
Patients receive carboplatin, paclitaxel, and cemiplimab-rwlc on day 1 of each cycle. Treatment repeats every 3 weeks for 4 up to cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. Patients then receive cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group VI: Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)Experimental Treatment9 Interventions
Patients receive carboplatin, paclitaxel, and pembrolizumab on day 1 of each cycle. Treatment repeats every 3 weeks for 4 up to cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. Patients then receive pembrolizumab on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group VII: Arm IX (atezolizumab, radiation)Experimental Treatment7 Interventions
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group VIII: Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)Experimental Treatment10 Interventions
Patients receive carboplatin, pemetrexed and nivolumab on day 1 of each cycle and ipilimumab on day 1 of every other cycle. Treatment repeats for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then continue to receive ipilmumab and nivolumab on the same schedule for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group IX: Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)Experimental Treatment9 Interventions
Patients receive carboplatin, paclitaxel and cemiplimab-rwlc on day 1 of each cycle. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pemetrexed and cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group X: Arm II (carboplatin, pemetrexed, cemiplimab, radiation)Experimental Treatment9 Interventions
Patients receive carboplatin, pemetrexed and cemiplimab-rwlc on day 1 of each cycle. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pemetrexed and cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Group XI: Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)Experimental Treatment9 Interventions
Patients receive carboplatin, pemetrexed, and pembrolizumab on day 1 of each cycle. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pemetrexed and pembrolizumab on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment fractions. All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18 florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also undergo collection of blood samples, as well as CT and MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cemiplimab
2015
Completed Phase 3
~1340
Nivolumab
2014
Completed Phase 3
~4750
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Radiation Therapy
2017
Completed Phase 3
~7250
Ipilimumab
2014
Completed Phase 3
~2620
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Nab-paclitaxel
2014
Completed Phase 3
~2030
Biospecimen Collection
2004
Completed Phase 2
~1700
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,346 Total Patients Enrolled
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,908 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
59 Previous Clinical Trials
3,754 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is of a mixed small cell type.My organs are healthy enough for treatment, as confirmed by my doctors.I have had an organ transplant and take medication to suppress my immune system.I am able to get out of my bed or chair and move around.I have received more than one cycle of immunotherapy for my current cancer.I need whole brain radiotherapy for brain metastases.I haven't been hospitalized for lung problems in the last 30 days.I have not received a live vaccine in the last 30 days.I have not taken any prohibited medications in the last 30 days.I am not pregnant or breastfeeding.I have recent (less than 6 months old) tumor samples for PD-L1 testing.I haven't had major surgery in the last 4 weeks.My doctor thinks I am a good candidate for immunotherapy.I am 18 years old or older.I've had radiotherapy that now limits further treatment due to risk to healthy organs.I am using a reliable birth control method during the study.I haven't had any cancer except skin cancer or localized cancer that hasn't spread in the last 3 years.I have been treated for an autoimmune disease in the last year.I haven't taken immunosuppressive drugs in the last 28 days, except for allowed exceptions.I have fluid buildup due to cancer in my abdomen or chest.My brain metastases can be treated with surgery or targeted radiation before starting chemo-immunotherapy.I do not have HIV, hepatitis B or C, or active tuberculosis.My doctor thinks another systemic therapy could work for me.I do not have severe heart issues, uncontrolled blood pressure, severe chest pain, irregular heartbeat, active stomach ulcers, bleeding disorders, or mental health conditions that would limit my participation.My lung cancer is at an advanced stage and can be measured for treatment response.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
- Group 2: Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
- Group 3: Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
- Group 4: Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
- Group 5: Arm VIII (pembrolizumab, radiation)
- Group 6: Arm X (cemiplimab-rwlc, radiation)
- Group 7: Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
- Group 8: Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
- Group 9: Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
- Group 10: Arm XI (nivolumab, ipilumumab, radiation)
- Group 11: Arm IX (atezolizumab, radiation)
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 goals are researchers trying to accomplish with this investigation?
"According to the sponsor, Varian Medical Systems, this clinical trial will assess a primary outcome of potential adverse events within 6 months. Additionally, secondary results will be evaluated such as quantitative and qualitative markers of treatment resource utilization when leveraging Ethos for radiation therapy (RT), progression-free survival estimated by Cox proportional hazards model with 95% confidence intervals (CI) presented by group, and overall survival also assessed using the same aforementioned methods."
Answered by AI
Is this research accepting new participants?
"Clinicaltrials.gov states that this medical trial is not actively soliciting participants at the moment, despite having been first posted on January 31st 2023 and last updated October 19th 2022. However, there are 2,045 other studies recruiting right now."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Vanderbilt University/Ingram Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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