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Checkpoint Inhibitor

SBRT +/− Nivolumab for Lung Cancer

Phase 2
Waitlist Available
Led By Joe Y Chang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with isolated lung parenchymal recurrent/persistent NSCLC after prior definitive surgery or radiotherapy/chemotherapy are eligible
Patients with multiple primary lung tumors (synchronous or metachronous) are eligible
Must not have
Patients with tumors > 7 cm or involving critical structures are not suitable for SABR
Patients with plans to receive other concomitant local therapy or systemic therapy while on this protocol, except at disease progression, are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how well radiation therapy works when given with or without the drug nivolumab to treat patients with early-stage non-small cell lung cancer or cancer that has come back.

Who is the study for?
This trial is for patients with stage I-IIA or recurrent non-small cell lung cancer without distant metastases. Participants must have completed any prior treatments at least 12 weeks before, tumors should be ≤7 cm (N0M0), and they should use effective birth control. They need to meet certain blood count criteria, have a performance status score of 0-2, and sign consent forms.
What is being tested?
The trial is testing the effectiveness of stereotactic body radiation therapy (SBRT) alone versus SBRT combined with Nivolumab, an immunotherapy drug. SBRT targets tumors precisely to minimize damage to healthy tissue while Nivolumab aims to boost the immune system's response against cancer cells.
What are the potential side effects?
Potential side effects include typical reactions from radiation like skin irritation and fatigue as well as those related to immunotherapy such as flu-like symptoms, potential organ inflammation due to immune response, and possible impact on hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer came back in the same place after surgery or chemo/radiotherapy.
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I have more than one primary lung cancer.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My lung cancer diagnosis was confirmed through a biopsy or cytology.
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I have only one cancer spot in my lung and no other cancer spots elsewhere.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor is not larger than 7 cm and does not involve critical body parts.
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I am not planning to receive other treatments while on this trial, except if my disease worsens.
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I do not have HIV, hepatitis B, or hepatitis C.
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I have not had any other cancers or spread of cancer in the last 3 years.
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I have not had treatments targeting immune system pathways.
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I have not been treated with PD1 or CTLA4 immunotherapy.
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My treatment plan does not meet the required safety standards for targeted radiation.
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I do not have any conditions that prevent me from receiving radiotherapy.
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I do not have an active autoimmune disease.

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
Event-free survival with events defined as local recurrence, regional recurrence, distant metastasis, secondary malignancy (including lung cancer), and death
Secondary study objectives
Incidence of adverse events related to stereotactic body radiation therapy and immunotherapy
Overall survival

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Anemia
27%
Fall
27%
Dyspnea
27%
Pain
27%
Depression
27%
Lymphocyte count decreased
27%
Platelet count decreased
20%
Chills
20%
Dizziness
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
20%
Edema limbs
13%
Skin infection
13%
Dysesthesia
13%
Edema
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Vomiting
13%
Tinnitus
13%
Rash
13%
Myalgia
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Proteinuria
7%
Bruising
7%
Oral lesions
7%
Hearing loss
7%
Anxiety
7%
Headaches
7%
Weakness (facial)
7%
Acute kidney injury
7%
Hypokalemia
7%
Lymphocytopenia
7%
Seizures
7%
Hearing impaired
7%
Hypernatremia
7%
Hypertension
7%
Neutrophil count decreased
7%
Headache
7%
Creatinine increased
7%
Fever
7%
Pleural effusion
7%
Death NOS
7%
Gait disturbance
7%
Nasal congestion
7%
Tremor
7%
Urinary urgency
7%
Amnesia
7%
Photophobia
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Erythema multitforme
7%
Lung infection
7%
Allergy (seasonal)
7%
Muscle weakness
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Hypoxic respiratory failure
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

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 II (stereotactic body radiation therapy, nivolumab)Experimental Treatment2 Interventions
Patients undergo stereotactic body radiation therapy over 1-2 weeks. Beginning within 36 hours before or after the first fraction of stereotactic body radiation therapy, patients also receive nivolumab IV over 30 minutes on day 1. Cycles with nivolumab repeat every 4 weeks for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (stereotactic body radiation therapy)Experimental Treatment1 Intervention
Patients undergo stereotactic body radiation therapy over 1-2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,668 Total Patients Enrolled
Joe Y ChangPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03110978 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm II (stereotactic body radiation therapy, nivolumab), Arm I (stereotactic body radiation therapy)
Non-Small Cell Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03110978 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03110978 — Phase 2
~23 spots leftby Jun 2026