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PD-L1 Inhibitor

Durvalumab + Radiation for Lung Cancer

Phase 2
Recruiting
Led By Charles Simone, 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
Early stage NSCLC (Stage I to IIIA; T1-4 excluding patients with satellite nodules in the same or ipsilateral lobes, N0; AJCC 8th edition)
ECOG/WHO PS 0-1 (KPS 70-100)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will compare the effectiveness of durvalumab + SBRT to SBRT alone in treating early-stage NSCLC.

Who is the study for?
This trial is for adults with early-stage non-small cell lung cancer who can't or choose not to have surgery. They should be in good physical condition, weigh over 30kg, and have a life expectancy of at least 12 weeks. Patients must not have certain mutations, autoimmune diseases, severe illnesses, or previous treatments that could interfere with the study.Check my eligibility
What is being tested?
The study is testing if combining durvalumab (a drug) with stereotactic body radiation therapy (SBRT) works better than SBRT alone for treating early-stage non-small cell lung cancer. Participants will receive both the drug and radiation to see if this improves their treatment outcomes.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid), fatigue, nausea and potential infusion-related reactions. Radiation therapy might lead to skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is in an early stage (I to IIIA) without spread to nearby nodes.
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I am fully active or able to carry out light work.
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I cannot or do not want to have surgery for my condition as advised by a specialist.
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I can sign and will follow the study's rules as explained in the consent form.
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I am 18 years old or older.
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I am a candidate for targeted radiation therapy.
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My organs and bone marrow are functioning well.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
50%
Fatigue
38%
Nausea
30%
Abdominal pain
28%
Arthralgia
28%
Pruritus
25%
Dyspnea
25%
Diarrhea
23%
Myalgia
23%
Dizziness
20%
Gum infection
20%
Pain
20%
Constipation
18%
Back pain
18%
Bladder infection
18%
Urinary tract pain
15%
Fever
15%
Rash maculo-papular
15%
Vomiting
13%
Anorexia
13%
Weight gain
10%
Hypothyroidism
10%
Nasal congestion
10%
Ascites
10%
Thromboembolic event
10%
Pain in extremity
10%
Mucositis oral
10%
Urinary hesitancy
10%
Urinary tract infection
8%
Gastroesophageal reflux disease
8%
Dry skin
8%
Pleural effusion
8%
Cough
8%
Peripheral sensory neuropathy
8%
Hypertension
8%
Anxiety
8%
Fall
8%
Vaginal hemorrhage
8%
Leukocytosis
5%
Creatinine Increased
5%
Hematoma
5%
Upper respiratory infection
5%
Generalized muscle weakness
5%
Allergic rhinitis
5%
Aspartate aminotransferase increased
5%
Vaginal yeast
5%
Skin infection
5%
Hyperglycemia
5%
Sinusitis
5%
Bone pain
5%
Non-cardiac chest pain
5%
Epistaxis
5%
Abdominal distension
5%
Sore throat
5%
Edema limbs
5%
Dry mouth
5%
Hyperkalemia
5%
Flank pain
5%
Urinary frequency
3%
Hypercalcemia
3%
Confusion
3%
Spinal fracture
3%
Atrial fibrillation
3%
Stroke
3%
Seizure
3%
Urinary urgency
3%
Edema cerebral
3%
Alanine aminotransferase increased
3%
Hypoalbuminemia
3%
Acute kidney injury
3%
Vaginal discharge
3%
Alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab + Tremelimumab
Durvalubmab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Early-stage Non-Small Cell Lung CancerExperimental Treatment2 Interventions
Participants will be diagnosed with Stage I-IIIA NSCLC and will be ineligible for surgery and will have any level of PD-L1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,929 Previous Clinical Trials
597,178 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,527,732 Total Patients Enrolled
Charles Simone, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04716946 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Participants with Early-stage Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04716946 — Phase 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04716946 — 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 other examples in the medical literature of Durvalumab's effects?

"City of Hope was the first institution to study durvalumab back in 2010 and, since then, 123 completed studies have been conducted. As of now, there are 338 active trials recruiting patients with a majority taking place in Middletown, New jersey."

Answered by AI

In how many different medical clinics is this clinical study being conducted?

"To make things more convenient for participants, the trial is being conducted at 9 sites close to major cities. The locations are Middletown, New york and Commack along with other locations within a commutable distance."

Answered by AI

Are we still taking people in for this research project?

"The clinical trial, which is hosted on clinicaltrials.gov, is currently recruiting patients. The study was posted on 1/27/2021 and updated on 10/12/2022. They are looking for a total of 40 participants that will be spread out across 9 locations."

Answered by AI

What is the most popular reason that doctors prescribe Durvalumab?

"Durvalumab is a common treatment for unresectable stage iii non-small cell lung cancer. Durvalumab has also shown to be effective against metastatic ureter urothelial carcinoma, and advance directives."

Answered by AI

What is the official government stance on Durvalumab?

"While Phase 2 trials don't have the same level of data to support efficacy, there is enough evidence of safety to give Durvalumab a score of 2."

Answered by AI

How many people can enroll in this clinical trial?

"That is correct. The study, which was created on 1/27/2021 and last updated on 10/12/2022, is still looking for enrollees. In total, they need 40 patients from 9 different locations."

Answered by AI
~8 spots leftby Feb 2025