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Platinum-containing Compound
Radiation + Immunotherapy for Non-Small Cell Lung Cancer
Phase 2 & 3
Recruiting
Led By Christine M Bestvina
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the addition of radiation therapy to the usual immunotherapy (with or without chemotherapy) treatment for patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) and who are also negative for a molecular marker called PD-L1.
Who is the study for?
Adults with advanced non-small cell lung cancer that's spread and is PD-L1 negative can join. They shouldn't have had chemotherapy or immunotherapy for metastatic NSCLC, no recent pneumonitis, no active infections or serious heart conditions, and must not be pregnant. Prior therapy for non-metastatic disease is okay if it ended over 6 months ago.Check my eligibility
What is being tested?
The trial tests adding radiation to usual treatments (immunotherapy with/without chemo) in stage IV lung cancer patients who are PD-L1 negative. It compares the effects of this combination against usual treatment alone on tumor growth and patient survival.See study design
What are the potential side effects?
Possible side effects include skin reactions from radiation, fatigue, immune-related reactions like inflammation in organs due to immunotherapy drugs (nivolumab, ipilimumab), and typical chemo side effects such as nausea, hair loss, blood disorders.
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) (Phase III)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Incidence of treatment-related adverse events
Objective response rate (ORR)
PFS
+1 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Creatinine increased
7%
Otitis externa
7%
Dehydration
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Blurred vision
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Hypertension
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (immunotherapy, +/- chemotherapy, SBRT)Experimental Treatment10 Interventions
Patients receive 1 of 6 treatment options as in Arm A. Patients also undergo 3 fractions of SBRT every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.
Group II: Arm A (immunotherapy, +/- chemotherapy)Experimental Treatment9 Interventions
Patients receive nivolumab intravenously (IV) over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2620
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,427 Total Patients Enrolled
Christine M BestvinaPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Steven E SchildPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.I haven't taken strong immune system drugs or more than 10 mg of steroids daily in the last 2 weeks.I don't have any serious illnesses that would stop me from following the study's requirements.I am 18 years old or older.I don't have active brain cancer symptoms, but small, symptom-free brain tumors are okay.I do not have hepatitis B or C.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have never needed steroids for lung inflammation.My cancer has a PD-L1 score of less than 1%.It has been over a week since I had any palliative radiotherapy.I am HIV positive, on treatment, and my viral load is undetectable.I have not received checkpoint inhibitors for my lung cancer.I have not had a transplant of tissue or an organ from another person.My kidneys are functioning well, with a creatinine clearance rate of at least 45 mL/min.I haven't received any live vaccines in the last 30 days.My lung cancer is at an advanced stage and I can't have combined chemo and radiation.I have been treated with checkpoint inhibitors for my lung cancer for no more than three weeks.My lung cancer is not squamous and has been tested for EGFR, ALK, and ROS1 without treatable mutations.I haven't had chemotherapy or immunotherapy for my cancer in the last 6 months.I don't have an active, progressing second cancer or one treated in the last 2 years, except for certain localized cancers.I have had less than 3 weeks of chemo or immunotherapy for advanced lung cancer.I am not pregnant or breastfeeding and have a recent negative pregnancy test.I have at least two cancer spots; one can be measured and won't be treated with radiation.I stopped chemotherapy for early-stage cancer or immunotherapy for stage III cancer over 6 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (immunotherapy, +/- chemotherapy)
- Group 2: Arm B (immunotherapy, +/- chemotherapy, 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.
Are patients currently being recruited for participation in this research?
"This study is currently looking for candidates, according to clinicaltrials.gov. The trial was first posted on December 21st, 2021 and was last edited on November 8th, 2022."
Answered by AI
What are the most recent findings on Stereotactic Body Radiation Therapy?
"City of Hope Comprehensive Cancer Center first used Stereotactic Body Radiation Therapy in 1997 and, since then, there have been 2508 completed trials. 2837 studies are still ongoing with a large portion taking place in Truckee, California."
Answered by AI
How many individuals are currently enrolled in this experiment?
"One hundred volunteers are required to enroll in this study. These participants must meet the pre-determined inclusion criteria. people from Gene Upshaw Memorial Tahoe Forest Cancer Center in Truckee, California and IHA Hematology Oncology Consultants-Canton in Canton, Michigan can participate in this trial."
Answered by AI
What types of cancer does Stereotactic Body Radiation Therapy typically target?
"Stereotactic Body Radiation Therapy not only offers treatment to those with metastatic cutaneous squamous cell carcinoma, but also patients suffering from melanoma, neoplasm metastasis and metastatic hepatocellular carcinoma."
Answered by AI
At how many research facilities is this experiment being conducted?
"There are 79 clinical trial sites for this research study, with 3 being Gene Upshaw Memorial Tahoe Forest Cancer Center in Truckee, California, IHA Hematology Oncology Consultants-Canton in Canton, Michigan and Fremont - Rideout Cancer Center in Marysville, New york."
Answered by AI
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