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Radiation

SBRT + Chemotherapy for Lung Cancer

Phase 1
Waitlist Available
Led By Abraham Wu, 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
Histologically confirmed non-small cell lung cancer
Age ≥ 18 years
Must not have
Prior radiation therapy to the lungs
Prior surgery or chemotherapy for this presentation of lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial will help determine if immunologic biomarkers and functional MRI images can help predict response to non-small cell lung cancer treatment and what side effects patients experience.

Who is the study for?
This trial is for adults with inoperable, locally-advanced non-small cell lung cancer (NSCLC) who haven't had surgery or chemo for their current cancer. They must be fit enough for treatment (Karnofsky Performance Status ≥70%) and willing to use contraception if of childbearing potential. People can't join if they've had previous lung radiation, are on high-dose steroids, need continuous oxygen, or have certain heart conditions.
What is being tested?
The study tests whether biomarkers and MRI images can predict how well NSCLC responds to Stereotactic Body Radiation Therapy (SBRT). Patients will receive SBRT alone without chemotherapy and will be monitored to gather information about the effectiveness of this approach from both medical and patient perspectives.
What are the potential side effects?
Possible side effects from SBRT may include fatigue, skin reactions at the treatment site, shortness of breath, chest pain, coughing up blood, difficulty swallowing due to inflammation of the esophagus, and rarely damage to surrounding organs like the heart or lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is confirmed to be non-small cell type.
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I am 18 years old or older.
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I am mostly able to care for myself and carry out daily activities.
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My kidney, liver, and blood counts are within healthy ranges.

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 to my lungs before.
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I have had surgery or chemotherapy for my current lung cancer.
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My cancer has spread to nearby lymph nodes.
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My cancer has spread to major blood vessels like the aorta or pulmonary artery.
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I take a daily steroid equivalent to or more than 10 mg of prednisone.
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I have previously been treated with specific immune therapies.
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My heart condition is not stable.
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I use oxygen all the time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
maximum tolerated dose (Cohort A)
Secondary study objectives
overall survival (Cohorts A & B)
≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B)

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593
21%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT

Trial Design

2Treatment groups
Experimental Treatment
Group I: B) 3-5cm OR Chemo ineligibleExperimental Treatment1 Intervention
Using intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT), the choice of which is determined by the radiation oncologist, patients will be treated in \< 5 fractions every other day. The total treatment dose will be between 45 and 54 Gy in \< 5 fractions per standard of care. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy at the discretion of their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year. FDG PET/CT scans and Pulmonary Function Tests (PFTs) will be obtained at 3 months and 9 months after SBRT.
Group II: A) >5cm,Chemo eligible (closed to accrual)Experimental Treatment2 Interventions
Patients will receive five fractions of either 8, 10, or 12 Gy to the gross tumor only. Following SBRT patients will be evaluated by their medical oncologist for consideration of adjuvant chemotherapy, starting 6-8 weeks post-RT. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy by their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,517 Total Patients Enrolled
Abraham Wu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
55 Total Patients Enrolled
Andreas Rimner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
373 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (SBRT) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT01899989 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: A) >5cm,Chemo eligible (closed to accrual), B) 3-5cm OR Chemo ineligible
Non-Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT01899989 — Phase 1
Stereotactic Body Radiation Therapy (SBRT) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01899989 — Phase 1
~2 spots leftby Jul 2025
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