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Monoclonal Antibodies

Durvalumab + SBRT for Non-Small Cell Lung Cancer (358 Trial)

Phase 2
Waitlist Available
Led By Hina Khan, MD
Research Sponsored by Hina Khan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after the last treatment
Stage III NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression on average for about 5 years.
Awards & highlights

358 Trial Summary

This trial is testing a combination of two treatments, Durvalumab and stereotactic body radiation therapy (SBRT), to see if it is more effective in fighting lung cancer than Durvalumab alone.

Who is the study for?
This trial is for adults over 18 with Stage III Non-Small Cell Lung Cancer who've completed chemoradiation but haven't progressed. They must have finished treatment within 3-7 weeks, have a tumor under 120cc suitable for SBRT, and meet certain blood and organ function criteria. Participants need to agree to use contraception and not be pregnant.Check my eligibility
What is being tested?
The study tests combining Durvalumab, an immune system-stimulating drug approved for lung cancer, with SBRT—a high-dose radiation therapy focused on the tumor. This combination is investigational in stage III patients to see if it's more effective post-chemoradiation.See study design
What are the potential side effects?
Durvalumab may cause immune-related reactions affecting organs, fatigue, infusion reactions like fever or chills, and increase infection risk. SBRT can lead to localized skin irritation or damage to nearby tissues due to its targeted high radiation doses.

358 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control during and for 6 months after treatment.
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My lung cancer is at stage III.
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I will get my first dose of durvalumab between 3 to 7 weeks after my last chemoradiation treatment.
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I am older than 18 years.
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I completed treatment combining chemotherapy and radiation, receiving a radiation dose between 50-65 Gy.
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My previous cancer treatments have been documented and submitted.
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My remaining tumor is small enough for targeted radiation therapy.
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I am not pregnant and have taken a test to confirm this within the last week.
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I am fully active or restricted in physically strenuous activity but can do light work.
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All my side effects from chemo or radiation are mild, except for hair loss.

358 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression for about 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression for about 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
Average progression-free survival of chemoradiation followed by SBRT and durvalumab for patients with locally advanced stage III NSCLC.
Number of patients experiencing grade 2 or higher toxicities during consolidation SBRT with concurrent durvalumab after chemoradiation for locally advanced stage III NSCLC
Secondary outcome measures
Average time to local-regional progression (LRP)
Overall survival (OS)
Time to distant metastasis (DM)

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

358 Trial Design

1Treatment groups
Experimental Treatment
Group I: Durvalumab and SBRTExperimental Treatment2 Interventions
Durvalumab 10mg/kg x 1 day, dose #1 to occur > 3 weeks and <7 weeks after last chemo/RT and prior to SBRT dose 1 (5-10 day time frame between Durvalumab and SBRT). SBRT boost will consist of 2 fractions delivered to the primary tumor only, over 1-2 weeks between the first and second treatments with durvalumab (see above for time frames). The dose will consist of 20Gy (2 fractions of 10Gy). 3 fractions are allowed for centrally located tumors Dose # 2 of durvalumab, (post SBRT) to be given 1-10 days post last SBRT. Durvalumab then to be given at 10mg/kg Q2 weeks (+/- 4 days) for a total of 12 months (maximum of 26 treatments total)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Hina KhanLead Sponsor
Brown UniversityLead Sponsor
452 Previous Clinical Trials
562,167 Total Patients Enrolled
LifespanOTHER
39 Previous Clinical Trials
41,052 Total Patients Enrolled

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03589547 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Durvalumab and SBRT
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03589547 — Phase 2
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03589547 — Phase 2

Frequently Asked Questions

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

For what purpose is Durvalumab most commonly prescribed?

"Durvalumab is an effective treatment for patients with unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma, and those that have not undergone prior treatment."

Answered by AI

Are investigators actively looking for new participants for this research project?

"Yes, the trial is still recruiting patients. The most recent update on clinicaltrials.gov was on February 23rd, 2022 and the posting date was May 13th, 2019."

Answered by AI

What is the official FDA stance on Durvalumab?

"Durvalumab's safety is based on Phase 2 trial data, which only provides limited evidence of its effectiveness and does not support efficacy."

Answered by AI

How many individuals can enroll in this trial?

"Yes, the information available on clinicaltrials.gov indicates that this trial is still underway and recruiting patients. The study was originally posted on May 13th, 2019 and received its most recent update on February 23rd, 2022. Presently, the investigators are looking for 25 participants at 2 separate locations."

Answered by AI

Could you provide some examples of other research done on Durvalumab?

"At the moment, 338 clinical studies are being conducted to test Durvalumab's efficacy. Of those trials, 51 have reached Phase 3. The majority of these tests are taking place in Cordoba, Texas; however, 12904 locations worldwide are running similar studies."

Answered by AI
~1 spots leftby Oct 2024