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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04870112




Registration number
NCT04870112
Ethics application status
Date submitted
16/04/2021
Date registered
3/05/2021

Titles & IDs
Public title
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
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
Secondary ID [1] 0 0
2020-006041-18
Secondary ID [2] 0 0
D9072C00001
Universal Trial Number (UTN)
Trial acronym
SCope-D1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Observed serum concentration (Ctrough)
Timepoint [1] 0 0
Approximately 16 months
Primary outcome [2] 0 0
Number of patients with injection site reactions and immune-mediated reactions
Timepoint [2] 0 0
Approximately 16 months
Primary outcome [3] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [3] 0 0
Approximately 16 months
Secondary outcome [1] 0 0
Time to maximum observed serum concentration (tmax) of durvalumab
Timepoint [1] 0 0
Approximately 16 months
Secondary outcome [2] 0 0
Area under the Plasma Concentration versus Time Curve (AUCt) of durvalumab
Timepoint [2] 0 0
Approximately 16 months
Secondary outcome [3] 0 0
Incidence of Adverse Events
Timepoint [3] 0 0
Approximately 16 months
Secondary outcome [4] 0 0
Changes in WHO/ECOG performance status
Timepoint [4] 0 0
Approximately 16 months
Secondary outcome [5] 0 0
Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
Timepoint [5] 0 0
Approximately 16 months
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
Timepoint [6] 0 0
Approximately 16 months
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
Timepoint [7] 0 0
Approximately 16 months
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)
Timepoint [8] 0 0
Approximately 16 months
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
Timepoint [9] 0 0
Approximately 16 months
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
Timepoint [10] 0 0
Approximately 16 months
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
Timepoint [11] 0 0
Approximately 16 months
Secondary outcome [12] 0 0
Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
Timepoint [12] 0 0
Approximately 16 months
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
Timepoint [13] 0 0
Approximately 16 months
Secondary outcome [14] 0 0
Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
Timepoint [14] 0 0
Approximately 16 months

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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2023
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
Spain
State/province [4] 0 0
Badalona
Country [5] 0 0
Spain
State/province [5] 0 0
Majadahonda
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taichung
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suli Bolus, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04870112