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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Event-free survival with events defined as local recurrence, regional recurrence, distant metastasis, secondary malignancy (including lung cancer), and death

Secondary outcome measures

Immunologic markers analyses

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

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Anorexia

21%

Chest pain

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Otitis externa

Sinusitis

Dehydration

Blurred vision

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Hypertension

Hypernatremia

Creatinine increased

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Eye pain

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

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

~780

Nivolumab

2014

Completed Phase 3

~4750

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,597 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left to join the study?

"Unfortunately, no more participants are being taken for this trial. It was initially published on June 26th 2017 and the last update was made October 6th 2022. Those in search of other trials may be interested to know that there are 5805 studies actively recruiting patients with lung cancer and 718 studies looking for people who will undergo Stereotactic Body Radiation Therapy."

Answered by AI

What maladies does Stereotactic Body Radiation Therapy typically help ameliorate?

"Stereotactic Body Radiation Therapy is routinely used to treat malignant neoplasms, but this form of radiation therapy has also been found useful in treating unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Are there any collateral risks associated with Stereotactic Body Radiation Therapy?

"Due to the lack of efficacy data, our team at Power assigned Stereotactic Body Radiation Therapy a score of 2 on our safety scale. There is however some evidence for its security as this trial is currently in Phase 2."

Answered by AI

Is this an innovative clinical trial?

"As of today, 718 studies related to Stereotactic Body Radiation Therapy are taking place across 49 countries and 2356 cities. The inaugural study was run by Ono Pharmaceutical Co. Ltd in 2012 with 659 participants for Phase 1 & 2 drug approval purposes. Since then, 270 trials have been completed."

Answered by AI

Are there any prior research projects that have explored the effects of Stereotactic Body Radiation Therapy?

"At this time, 718 trials are being conducted for Stereotactic Body Radiation Therapy. 82 of these studies have advanced to the third phase and most originate from Basel, BE; however there are 40285 locations conducting experiments with this form of therapy."

Answered by AI

How many participants are actively contributing to this research endeavor?

"At present, this study is not accepting any new participants. The trial first began recruiting on June 26th 2017 and was last updated October 6th 2022. For those seeking out other trials, there are 5805 clinical research studies actively searching for lung cancer patients and 718 Stereotactic Body Radiation Therapy trials enrolling now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer

2017. "Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03110978.

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