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Radiation

Stereotactic Radiosurgery for Brain Metastases from Lung Cancer

Phase 2

Recruiting

Led By Luke Pike, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment

Radiographic diagnosis of up to 10 brain metastases on contrast-enhanced MRI

Must not have

Prior brain-directed radiotherapy

Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether stereotactic radiosurgery/SRS is an effective treatment for people newly diagnosed with brain metastases from small cell lung cancer/SCLC.

Who is the study for?

This trial is for adults with small cell lung cancer that has spread to the brain. They must be able to consent, have a good performance status (able to carry out daily activities), and women must not be pregnant. People can't join if they've had previous brain radiotherapy, are pregnant or breastfeeding, can't undergo MRI scans, or have uncontrolled systemic disease.

What is being tested?

The study is testing Stereotactic Radiosurgery (SRS) as a treatment for patients with newly diagnosed brain metastases from small cell lung cancer. It will involve precise delivery of radiation to the brain tumors without affecting surrounding healthy tissue.

What are the potential side effects?

Potential side effects of SRS may include headaches, fatigue, nausea, hair loss at the treatment site, swelling in the brain which might cause neurological symptoms like weakness or difficulty speaking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not able to become pregnant or I have a negative pregnancy test.

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I have up to 10 brain tumors identified by MRI.

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I am 18 years old or older.

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I can care for myself and perform daily activities.

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My diagnosis is small cell lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy targeted at my brain.

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My cancer has spread to the lining of my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702

32%

Fatigue

28%

Lymphocyte count decreased

24%

Cough

20%

Back pain

20%

Rash acneiform

16%

Anorexia

16%

Dry skin

16%

Hyperglycemia

16%

Rash maculo-papular

12%

Aspartate aminotransferase increased

12%

Non-cardiac chest pain

12%

Diarrhea

12%

Dyspepsia

12%

Headache

12%

Nausea

12%

Pain

12%

Pain in extremity

Myalgia

Urinary tract pain

Weight loss

Watering eyes

Wheezing

Arthralgia

Edema limbs

Abdominal pain

Paronychia

Pruritus

Blurred vision

Skin and subcutaneous tissue disorders - Other, specify

Sore throat

Vomiting

Urinary urgency

Urinary tract infection

Upper respiratory infection

Skin infection

White blood cell decreased

Insomnia

Lethargy

Infusion site extravasation

Ear pain

Oral hemorrhage

Conjunctivitis

Alkaline phosphatase increased

Blood bilirubin increased

Bone pain

Bruising

Depression

Dry eye

Dysgeusia

Dysphagia

Edema face

Epistaxis

Flashing lights

Flu like symptoms

Gastroesophageal reflux disease

Hot flashes

Hyperkalemia

Hypernatremia

Nail loss

Nail ridging

Neck pain

Neutrophil count decreased

Papulopustular rash

Platelet count decreased

Pneumonitis

Fracture

Fall

Skin hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Radiosurgery Followed by Erlotinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with small cell lung cancer with brain metastasesExperimental Treatment2 Interventions

Participants may be newly diagnosed small cell lung cancer with brain metastases at initial staging, or can alternatively be patients who develop brain metastases on therapy or during surveillance of systemic disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

Cerebrospinal fluid collection

2015

N/A

~220