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A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer (SCope-D1)

Primary Purpose

Non-Small Cell Lung Cancer, Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Cisplatin
Carboplatin
Etoposide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring imfinzi, durvalumab

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with NSCLC

Patients with SCLC

Arm Description

Patients with Non-Small Cell Lung Cancer

Patients with Small Cell Lung Cancer

Outcomes

Primary Outcome Measures

Observed serum concentration (Ctrough)
Number of patients with injection site reactions and immune-mediated reactions
Maximum observed serum concentration (Cmax)

Secondary Outcome Measures

Time to maximum observed serum concentration (tmax) of durvalumab
Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab
Incidence of Adverse Events
Changes in WHO/ECOG performance status
Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry
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)
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology
Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)
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
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
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius
Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
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
Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug

Full Information

First Posted
April 16, 2021
Last Updated
September 26, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04870112
Brief Title
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Acronym
SCope-D1
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Small Cell Lung Cancer
Keywords
imfinzi, durvalumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with NSCLC
Arm Type
Experimental
Arm Description
Patients with Non-Small Cell Lung Cancer
Arm Title
Patients with SCLC
Arm Type
Experimental
Arm Description
Patients with Small Cell Lung Cancer
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736, IMFINZI
Intervention Description
Anti-PD-L1 antibody
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Observed serum concentration (Ctrough)
Time Frame
Approximately 16 months
Title
Number of patients with injection site reactions and immune-mediated reactions
Time Frame
Approximately 16 months
Title
Maximum observed serum concentration (Cmax)
Time Frame
Approximately 16 months
Secondary Outcome Measure Information:
Title
Time to maximum observed serum concentration (tmax) of durvalumab
Time Frame
Approximately 16 months
Title
Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab
Time Frame
Approximately 16 months
Title
Incidence of Adverse Events
Time Frame
Approximately 16 months
Title
Changes in WHO/ECOG performance status
Time Frame
Approximately 16 months
Title
Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
Time Frame
Approximately 16 months
Title
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry
Description
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)
Time Frame
Approximately 16 months
Title
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology
Description
Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
Time Frame
Approximately 16 months
Title
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)
Time Frame
Approximately 16 months
Title
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
Time Frame
Approximately 16 months
Title
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
Time Frame
Approximately 16 months
Title
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius
Time Frame
Approximately 16 months
Title
Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
Time Frame
Approximately 16 months
Title
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
Time Frame
Approximately 16 months
Title
Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
Time Frame
Approximately 16 months
Other Pre-specified Outcome Measures:
Title
Incidence of injection site reactions reported through ISQ Symptoms questionnaire
Time Frame
Approximately 16 months
Title
Treatment satisfaction reported using ISQ Satisfaction questionnaire
Time Frame
Approximately 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suli Bolus, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer

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