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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Ipilimumab
2015
Completed Phase 3
~3420
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,602 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

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Lung Carcinoma Research Study Groups: Arm B (immunotherapy, +/- chemotherapy, radiation therapy), Arm A (immunotherapy, +/- chemotherapy)
Lung Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04929041 — Phase 2 & 3
Carboplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929041 — Phase 2 & 3
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