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Monoclonal Antibodies

Durvalumab for Non-Small Cell Lung Cancer (SCope-D1 Trial)

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 16 months
Awards & highlights

SCope-D1 Trial Summary

This trial has two parts: in the first, doses of a new cancer drug are tested to see how well they work, and in the second, the most effective dose is given to a larger group to see how the body processes it.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer

SCope-D1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum observed serum concentration (Cmax)
Injection Site Reaction
Observed serum concentration (Ctrough)
Secondary outcome measures
Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab
Changes in WHO/ECOG performance status
Incidence of Adverse Events
+11 more
Other outcome measures
Incidence of injection site reactions reported through ISQ Symptoms questionnaire
Treatment satisfaction reported using ISQ Satisfaction questionnaire

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%
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

SCope-D1 Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients with SCLCExperimental Treatment4 Interventions
Patients with Small Cell Lung Cancer
Group II: Patients with NSCLCExperimental Treatment1 Intervention
Patients with Non-Small Cell Lung Cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Durvalumab
2017
Completed Phase 2
~3870
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,768 Total Patients Enrolled
Erik Goluboff, MDStudy DirectorAstraZeneca
Suli Bolus, MDStudy DirectorAstraZeneca

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04870112 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Patients with SCLC, Patients with NSCLC
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04870112 — Phase 1
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04870112 — Phase 1

Frequently Asked Questions

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

Are there any available vacancies for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this trial, first posted on June 28th 2021 is currently seeking participants. The latest update was published on November 17 2022 and the study requires 124 recruits from 5 different sites."

Answered by AI

Does the trial accept participants less than sixty years old?

"To be part of this medical study, participants must lie within the 18-130 year old age bracket. As an aside, there are 226 trials for minors and 3497 studies targeting individuals over 65 years of age."

Answered by AI

Who would be the ideal candidates to enroll in this medical experiment?

"This clinical trial is attempting to enroll 124 participants who suffer from lung cancer and are between 18-130 years old."

Answered by AI

Are there any locations in North America where this investigation is taking place?

"Currently, the 5 clinical sites participating in this trial are located in Tucson, Lexington and Fairfax amongst other cities. To reduce commute time, it is advantageous to pick a site that is closest geographically if one decides to enroll."

Answered by AI

Could you please discuss any prior experiments that utilized Durvalumab?

"Currently, Durvalumab is the subject of 1534 ongoing clinical trials with 442 in Phase 3. These medical studies are primarily located in Shanghai, China but there are 79345 additional sites hosting these experiments worldwide."

Answered by AI

What therapeutic applications does Durvalumab commonly target?

"Durvalumab is usually used to treat hodgkin disease, but it may be beneficial for patients with malignant pleural mesothelioma, advanced head and neck cancer, and other serious conditions."

Answered by AI

What is the enrollment quota for this clinical trial?

"Affirmative. As stated on clinicaltrials.gov, this medical examination is actively recruiting participants with the trial beginning on June 28th 2021 and recently updated on November 17th 2022. A total of 124 individuals are being recruited from 5 distinct locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
2021. "A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04870112.
~5 spots leftby Apr 2025
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