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Durvalumab for Early Stage Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Joel W Neal, MD,PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not received immunotherapy (PD-1, PD-L1, or CTLA-4 antibodies) or be intended to receive immunotherapy, apart from this study
Pathologically proven NSCLC without small cell lung cancer component
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing whether a certain drug can reduce the number of cancer cells in the blood of people who have already had treatment for their cancer.
Who is the study for?
This trial is for adults over 18 with early-stage NSCLC who've completed surgery and/or radiation, possibly chemotherapy, but not immunotherapy. They must have no remaining cancer detectable except by ctDNA, be in good health with a life expectancy of at least 12 weeks, and agree to contraception. Those with certain mutations or other cancers under treatment can't join.Check my eligibility
What is being tested?
The study tests if Durvalumab can reduce the number of circulating cancer cells detected by AVENIO ctDNA Surveillance Kit in blood after standard treatment in patients showing minimal residual disease. It aims to prevent cancer recurrence by targeting these cells.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation of organs like lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had immunotherapy and do not plan to outside this study.
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My lung cancer is confirmed and not small cell type.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have no signs of cancer after my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease in ctDNA Level
Secondary outcome measures
Disease-free survival (DFS)
Overall survival (OS)
Presence or absence of detectable ctDNA
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 1 minimal residue disease positive(MRD+)Experimental Treatment2 Interventions
Subjects with detectable ctDNA (MRD+) will receive up to 12 cycles of durvalumab (1500mg dose by intravenous (by vein) injection every 28 days). ctDNA will be re checked following 2 cycles (8 weeks) of durvalumab and compared to baseline levels. In the absence of progression or toxicity after 2 cycles, subject will continue with durvalumab to complete 1 year of treatment about 10 additional cycles).
Subjects will be monitored for secondary endpoints of progression free survival (PFS) and overall survival (OS).
Group II: Cohort 2 minimal residue disease negative (MRD-)Active Control1 Intervention
Subjects with undetectable ctDNA (MRD) will receive Standard of care and no treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,613,280 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,515 Total Patients Enrolled
Joel W Neal, MD,PhDPrincipal InvestigatorStanford Universiy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is between stages IA2 and IIIC, not including stage IA1 unless it has come back.I have severe nerve pain or damage, but it might still be considered.I do not have any ongoing infections.I will need to continue taking medication to suppress my immune system.I or my partner will use effective birth control during and for 8 months after the study.I don't have major side effects from previous treatments, except for some exceptions.I do not have severe autoimmune or inflammatory disorders that could interfere with durvalumab treatment.I have had severe lung inflammation from past radiation.I have had an organ transplant and take medicine to lower my immune response.You are expected to live for at least 12 more weeks.I have not had immunotherapy and do not plan to outside this study.I am currently being treated for another cancer, except hormone therapy for breast or prostate cancer.My lung cancer is confirmed and not small cell type.I do not have any uncontrolled illnesses.I had surgery or radiation aimed at curing my cancer, and may have had chemotherapy.I am 18 years old or older.You have a history of a weakened immune system from birth.I am not pregnant or breastfeeding.I am fully active or can carry out light work.I finished all my cancer treatments less than 32 weeks ago.There is a sample of your tumor tissue or DNA available for testing before starting the treatment.I have no signs of cancer after my treatment.My cancer does not have specific genetic changes (EGFR, ALK, ROS1) or it has EGFR changes but also has PD-L1 expression over 1% and I'm not planned to receive certain targeted therapy.If you have a serious health problem that won't get worse from taking durvalumab, you might still be able to join the study if the researchers agree.Your test results from the lab are within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 minimal residue disease positive(MRD+)
- Group 2: Cohort 2 minimal residue disease negative (MRD-)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What pathologies is Durvalumab employed to address?
"Durvalumab is an effective treatment option for those with unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma, and other conditions that have yet to be addressed."
Answered by AI
What is the number of participants in this experiment?
"Affirmative. The clinicaltrials.gov website reveals that this medical trial, which was initially announced on April 8th 2021, is actively recruiting. Approximately 80 participants need to be sourced from 1 site."
Answered by AI
Has Durvalumab been tested in other medical experiments?
"Presently, 333 studies are underway assessing the effectiveness of Durvalumab. Of these trials, 52 have progressed to a Phase 3 level and there are 12937 locations running clinical investigations into this drug. Notably, several sites in Cordoba, Texas are conducing research on its efficacy."
Answered by AI
Is this investigation currently in search of participants?
"Affirmative. According to clinicaltrials.gov, this investigation is actively seeking out suitable candidates as of March 25th 2022. The research began on April 8th 2021 and needs 80 volunteers from 1 medical establishment."
Answered by AI
What potential hazards should be taken into consideration when administering Durvalumab?
"Durvalumab's safety has been backed up by a handful of studies, resulting in an estimated score of 2. Unfortunately, there is limited data to confirm its efficacy at this time."
Answered by AI
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