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Platinum-containing Compound

Radiation + Immunotherapy for Non-Small Cell Lung Cancer

Phase 2 & 3
Recruiting
Led By Steven E Schild
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
No prior treatment with checkpoint inhibitors for metastatic lung cancer
No prior allogeneic tissue/solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received checkpoint inhibitors for my lung cancer.
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I have not had a transplant of tissue or an organ from another person.
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I have never needed steroids for lung inflammation.
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My lung cancer is not squamous and has been tested for specific genetic changes.
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I don't have an active, progressing second cancer or one treated in the last 2 years, except for certain localized cancers.
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My lung cancer is at stage IV, or it's at stage IIIB/IIIC and I can't have combined chemo and radiation.
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It's been over a week since I had any palliative radiotherapy.
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I have not had chemotherapy or immunotherapy for advanced lung cancer.
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I am 18 years old or older.
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I am HIV positive, on treatment, and my viral load is undetectable.
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I haven't taken strong immune system drugs or more than 10 mg of prednisone daily in the last 2 weeks.
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I have never needed steroids for lung inflammation.
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My kidneys are functioning well, with a creatinine clearance rate of at least 45 mL/min.
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I have not received checkpoint inhibitors for my lung cancer.
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I have not had a transplant of tissue or an organ from another person.
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I don't have active brain cancer symptoms, but small, symptom-free brain tumors are okay.
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I am not pregnant or nursing and have a recent negative pregnancy test.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
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My cancer has a PD-L1 score of less than 1%.
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I don't have any serious illnesses that are not under control.
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I haven't received any live vaccines in the last 30 days.
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I can take care of myself and am up and about more than half of my waking hours.
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I have at least two cancer spots; one can be measured and won't be treated with radiation.
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I finished chemotherapy for early-stage cancer or immunotherapy for stage III cancer over 6 months ago.

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

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 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
79%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anorexia
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Depression
14%
Hypotension
14%
Diarrhea
14%
Dysphagia
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Dehydration
7%
Eye pain
7%
White blood cell count decreased
7%
Amnesia
7%
Productive cough
7%
Bone marrow biopsy
7%
Dysuria
7%
Dysgeusia
7%
Dementia
7%
Confusion
7%
Creatinine increased
7%
Hearing impaired
7%
Hypertension
7%
Rash
7%
Hypernatremia
7%
Blurred vision
7%
Throat pain
7%
Hemorrhoids
7%
Pneumonitis
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
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%
Sinusitis
7%
Alopecia
7%
Esophagitis
7%
Otitis externa
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

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, SBRT)Experimental Treatment15 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 Treatment14 Interventions
See Detailed Description
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
~2260
Biopsy
2014
Completed Phase 4
~1160
Biospecimen Collection
2004
Completed Phase 1
~1850
Carboplatin
2014
Completed Phase 3
~6670
Computed Tomography
2017
Completed Phase 2
~2710
Ipilimumab
2014
Completed Phase 3
~2690
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Nab-paclitaxel
2014
Completed Phase 3
~2030
Nivolumab
2014
Completed Phase 3
~4800
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 3
~2070
Pemetrexed
2014
Completed Phase 3
~5250
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,584 Previous Clinical Trials
41,239,691 Total Patients Enrolled
Steven E SchildPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Carboplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT04929041 — Phase 2 & 3
Lung Carcinoma Research Study Groups: Arm B (immunotherapy, +/- chemotherapy, SBRT), 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

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
~285 spots leftby Dec 2027