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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)

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ClinicalTrials.gov Identifier: NCT04870112
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 16, 2021
First Posted Date  ICMJE May 3, 2021
Last Update Posted Date September 13, 2021
Actual Study Start Date  ICMJE June 28, 2021
Estimated Primary Completion Date January 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2021)
  • Observed serum concentration (Ctrough) [ Time Frame: Approximately 16 months ]
  • Number of patients with injection site reactions and immune-mediated reactions [ Time Frame: Approximately 16 months ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 16 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2021)
  • Time to maximum observed serum concentration (tmax) of durvalumab [ Time Frame: Approximately 16 months ]
  • Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab [ Time Frame: Approximately 16 months ]
  • Incidence of Adverse Events [ Time Frame: Approximately 16 months ]
  • Changes in WHO/ECOG performance status [ Time Frame: Approximately 16 months ]
  • Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals [ Time Frame: Approximately 16 months ]
  • Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry [ Time Frame: Approximately 16 months ]
    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 [ Time Frame: Approximately 16 months ]
    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) [ Time Frame: Approximately 16 months ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies [ Time Frame: Approximately 16 months ]
  • 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 ]
  • Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug [ Time Frame: Approximately 16 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2021)
  • Incidence of injection site reactions reported through ISQ Symptoms questionnaire [ Time Frame: Approximately 16 months ]
  • Treatment satisfaction reported using ISQ Satisfaction questionnaire [ Time Frame: Approximately 16 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Durvalumab
    Anti-PD-L1 antibody
    Other Name: MEDI4736, IMFINZI
  • Drug: Cisplatin
    Chemotherapy
  • Drug: Carboplatin
    Chemotherapy
  • Drug: Etoposide
    Chemotherapy
Study Arms  ICMJE
  • Experimental: Patients with NSCLC
    Patients with Non-Small Cell Lung Cancer
    Intervention: Drug: Durvalumab
  • Experimental: Patients with SCLC
    Patients with Small Cell Lung Cancer
    Interventions:
    • Drug: Durvalumab
    • Drug: Cisplatin
    • Drug: Carboplatin
    • Drug: Etoposide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2021)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 19, 2024
Estimated Primary Completion Date January 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE New Zealand,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04870112
Other Study ID Numbers  ICMJE D9072C00001
2020-006041-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Erik Goluboff, MD AstraZeneca
PRS Account AstraZeneca
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP