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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS) (Phase III)
Progression-free survival (PFS) (Phase II)
Secondary study objectives
Incidence of treatment-related adverse events
Objective response rate (ORR)
PFS
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
Group I: Arm B (immunotherapy, +/- chemotherapy, radiation therapy)Experimental Treatment10 Interventions
Patients receive 1 of 6 treatment options as in Arm A. Patients also undergo 3 fractions of radiation therapy 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
Radiation Therapy
2017
Completed Phase 3
~7250
Echocardiography
2013
Completed Phase 4
~11580
Positron Emission Tomography
2011
Completed Phase 2
~2200
Biopsy
2014
Completed Phase 4
~1150
Biospecimen Collection
2004
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2790
Ipilimumab
2015
Completed Phase 3
~3420
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Nivolumab
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,111,670 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 B (immunotherapy, +/- chemotherapy, radiation therapy)
- Group 2: Arm A (immunotherapy, +/- chemotherapy)
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.