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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

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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Small Cell Lung Cancer Drug: Durvalumab Drug: Cisplatin Drug: Carboplatin Drug: Etoposide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : January 19, 2024
Estimated Study Completion Date : January 19, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Patients with NSCLC
Patients with Non-Small Cell Lung Cancer
Drug: Durvalumab
Anti-PD-L1 antibody
Other Name: MEDI4736, IMFINZI

Experimental: Patients with SCLC
Patients with Small Cell Lung Cancer
Drug: Durvalumab
Anti-PD-L1 antibody
Other Name: MEDI4736, IMFINZI

Drug: Cisplatin
Chemotherapy

Drug: Carboplatin
Chemotherapy

Drug: Etoposide
Chemotherapy




Primary Outcome Measures :
  1. Observed serum concentration (Ctrough) [ Time Frame: Approximately 16 months ]
  2. Number of patients with injection site reactions and immune-mediated reactions [ Time Frame: Approximately 16 months ]
  3. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 16 months ]

Secondary Outcome Measures :
  1. Time to maximum observed serum concentration (tmax) of durvalumab [ Time Frame: Approximately 16 months ]
  2. Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab [ Time Frame: Approximately 16 months ]
  3. Incidence of Adverse Events [ Time Frame: Approximately 16 months ]
  4. Changes in WHO/ECOG performance status [ Time Frame: Approximately 16 months ]
  5. Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals [ Time Frame: Approximately 16 months ]
  6. 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)

  7. 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.

  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies [ Time Frame: Approximately 16 months ]
  13. 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 ]
  14. Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug [ Time Frame: Approximately 16 months ]

Other Outcome Measures:
  1. Incidence of injection site reactions reported through ISQ Symptoms questionnaire [ Time Frame: Approximately 16 months ]
  2. Treatment satisfaction reported using ISQ Satisfaction questionnaire [ Time Frame: Approximately 16 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870112


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Arizona
Research Site Not yet recruiting
Tucson, Arizona, United States, 85711
United States, Georgia
Research Site Not yet recruiting
Augusta, Georgia, United States, 30912
United States, Indiana
Research Site Withdrawn
Indianapolis, Indiana, United States, 46250
United States, Kentucky
Research Site Not yet recruiting
Lexington, Kentucky, United States, 40536
United States, Maryland
Research Site Withdrawn
Baltimore, Maryland, United States, 21287
United States, Montana
Research Site Not yet recruiting
Billings, Montana, United States, 59101
United States, North Carolina
Research Site Suspended
Charlotte, North Carolina, United States, 28204
United States, Ohio
Research Site Suspended
Cleveland, Ohio, United States, 44109
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77090
United States, Virginia
Research Site Recruiting
Fairfax, Virginia, United States, 22031
New Zealand
Research Site Recruiting
Christchurch, New Zealand, 8011
Research Site Withdrawn
Grafton, New Zealand, 1023
Spain
Research Site Not yet recruiting
Badalona, Spain, 08916
Research Site Not yet recruiting
Madrid, Spain, 28041
Research Site Not yet recruiting
Majadahonda, Spain, 28222
Research Site Not yet recruiting
Sevilla, Spain, 41009
Taiwan
Research Site Not yet recruiting
Taichung, Taiwan, 40705
Research Site Not yet recruiting
Taipei City, Taiwan, 11217
Research Site Not yet recruiting
Taipei City, Taiwan, 114
Research Site Not yet recruiting
Taipei, Taiwan, 235
Research Site Withdrawn
Taoyuan, Taiwan, 333
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Erik Goluboff, MD AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04870112    
Other Study ID Numbers: D9072C00001
2020-006041-18 ( EudraCT Number )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
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
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
imfinzi
durvalumab
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Durvalumab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological