Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04870112
Registration number
NCT04870112
Ethics application status
Date submitted
16/04/2021
Date registered
3/05/2021
Date last updated
8/03/2024
Titles & IDs
Public title
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Query!
Scientific title
A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
Query!
Secondary ID [1]
0
0
2020-006041-18
Query!
Secondary ID [2]
0
0
D9072C00001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SCope-D1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
0
0
Query!
Small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Experimental: Patients with NSCLC - Patients with Non-Small Cell Lung Cancer
Experimental: Patients with SCLC - Patients with Small Cell Lung Cancer
Treatment: Drugs: Durvalumab
Anti-PD-L1 antibody
Treatment: Drugs: Cisplatin
Chemotherapy
Treatment: Drugs: Carboplatin
Chemotherapy
Treatment: Drugs: Etoposide
Chemotherapy
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Observed serum concentration (Ctrough)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Approximately 16 months
Query!
Primary outcome [2]
0
0
Number of patients with injection site reactions and immune-mediated reactions
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Approximately 16 months
Query!
Primary outcome [3]
0
0
Maximum observed serum concentration (Cmax)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Approximately 16 months
Query!
Secondary outcome [1]
0
0
Time to maximum observed serum concentration (tmax) of durvalumab
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Approximately 16 months
Query!
Secondary outcome [2]
0
0
Area under the Plasma Concentration versus Time Curve (AUCt) of durvalumab
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Approximately 16 months
Query!
Secondary outcome [3]
0
0
Incidence of Adverse Events
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Approximately 16 months
Query!
Secondary outcome [4]
0
0
Changes in WHO/ECOG performance status
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Approximately 16 months
Query!
Secondary outcome [5]
0
0
Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Approximately 16 months
Query!
Secondary outcome [6]
0
0
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry
Query!
Assessment method [6]
0
0
Clinical chemistry will be assessed by liver function(Alanine aminotransferase, Aspartate aminotransferase, albumin, total bilirubin), kidney function (e.g. Urea, Creatinine) and endocrine function(TSH, T3 free,T4 free)
Query!
Timepoint [6]
0
0
Approximately 16 months
Query!
Secondary outcome [7]
0
0
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology
Query!
Assessment method [7]
0
0
Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
Query!
Timepoint [7]
0
0
Approximately 16 months
Query!
Secondary outcome [8]
0
0
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Approximately 16 months
Query!
Secondary outcome [9]
0
0
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (pulse rate) in beats per minute
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Approximately 16 months
Query!
Secondary outcome [10]
0
0
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (respiration rate) in breaths per minute
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Approximately 16 months
Query!
Secondary outcome [11]
0
0
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Approximately 16 months
Query!
Secondary outcome [12]
0
0
Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Approximately 16 months
Query!
Secondary outcome [13]
0
0
Part 2 only: Overall Response Rate (ORR) - proportion of participants with a complete or partial response to treatment as determined using RECIST 1.1 guidelines
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Approximately 16 months
Query!
Secondary outcome [14]
0
0
Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Approximately 16 months
Query!
Eligibility
Key inclusion criteria
- Histologically or cytologically documented unresectable Stage III NSCLC that has not
progressed following definitive platinum based CRT or extensive disease (Stage IV)
SCLC
- ECOG performance status of 0 or 1
- For participants with SCLC: At least 1 lesion, not previously irradiated, that
qualifies as a RECIST 1.1 TL at baseline
- Absence of EGFR mutation or ALK rearrangement prior to screening
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
130
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- History of allogeneic organ transplantation
- Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus,
Sarcoidosis syndrome, or Wegener syndrome
- Uncontrolled intercurrent illness
- History of another primary malignancy
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human
immunodeficiency virus (HIV)
- Brain metastases or spinal cord compression
- Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy,
excluding alopecia
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/06/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/08/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
18
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Texas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Virginia
Query!
Country [3]
0
0
New Zealand
Query!
State/province [3]
0
0
Christchurch
Query!
Country [4]
0
0
Spain
Query!
State/province [4]
0
0
Badalona
Query!
Country [5]
0
0
Spain
Query!
State/province [5]
0
0
Majadahonda
Query!
Country [6]
0
0
Taiwan
Query!
State/province [6]
0
0
Taichung
Query!
Country [7]
0
0
Taiwan
Query!
State/province [7]
0
0
Taipei City
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study has 2 parts: dose finding and dose confirmatory.
In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find
out what dose of durvalumab administered as an infusion under the skin acts similarly to
durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be
enrolled for a 12 month treatment period and 3 months follow up
In Part 2, the dose confirmation phase of the study, participants will receive the dose of
durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about
the way that the body processes durvalumab when administered as an infusion under the skin.
Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally,
up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy)
will be enrolled for a 12 treatment period and a 3 month follow-up period.
AstraZeneca has decided to stop further enrollment and the study was terminated when all
patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical
concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04870112
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Suli Bolus, MD
Query!
Address
0
0
AstraZeneca
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04870112
Download to PDF