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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
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 • NCT0204544687%
Fatigue
53%
Nausea
33%
Cough
27%
Depression
27%
Pain
27%
Anemia
27%
Dyspnea
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Fall
20%
Chest pain
20%
Chills
20%
Neutropenia
20%
Diarrhea
20%
Dizziness
20%
Edema limbs
13%
Dysgeusia
13%
Constipation
13%
Skin infection
13%
Back pain
13%
Dysesthesia
13%
Rash
13%
Myalgia
13%
Edema
13%
Delirium
13%
Weakness (limb)
13%
Tinnitus
13%
Vomiting
13%
Weight loss
13%
Insomnia
7%
Tremor
7%
Lung infection
7%
Hypoxia
7%
Urinary frequency
7%
Seizures
7%
Amnesia
7%
Hearing loss
7%
Hypoxic respiratory failure
7%
Allergy (seasonal)
7%
Urinary urgency
7%
Erythema multitforme
7%
Proteinuria
7%
Encephalopathy
7%
Acute kidney injury
7%
Dysphagia
7%
Lymphocytopenia
7%
Cognitive disturbance
7%
Nasal congestion
7%
Neutrophil count decreased
7%
Headaches
7%
Hearing impaired
7%
Bruising
7%
Death NOS
7%
Febrile Neutropenia
7%
Muscle weakness
7%
Sneezing
7%
Hypertension
7%
Pleural effusion
7%
Photophobia
7%
Anorexia
7%
Anxiety
7%
Creatinine increased
7%
Hypokalemia
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Sleep apnea
7%
Shingles
7%
Fever
7%
Gait disturbance
7%
Headache
7%
Hypernatremia
7%
Oral lesions
7%
Low white blood count
7%
Weakness (facial)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy
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
~2210
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2610
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Nivolumab
2014
Completed Phase 3
~4740
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,958,974 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.
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