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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 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

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%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Edema limbs

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Edema

13%

Dysesthesia

13%

Dysgeusia

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Myalgia

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Headaches

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Oral lesions

Lymphocytopenia

Weakness (facial)

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Pleural effusion

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Muscle weakness

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

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

2014