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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04870112
Collaborator
(none)
124
Enrollment
21
Locations
2
Arms
30.7
Anticipated Duration (Months)
5.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 28, 2021
Anticipated Primary Completion Date :
Jan 19, 2024
Anticipated Study Completion Date :
Jan 19, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with NSCLC

Patients with Non-Small Cell Lung Cancer

Drug: Durvalumab
Anti-PD-L1 antibody
Other Names:
  • MEDI4736, IMFINZI

    		•
    Experimental: Patients with SCLC

    Patients with Small Cell Lung Cancer

    Drug: Durvalumab
    Anti-PD-L1 antibody
    Other Names:
  • MEDI4736, IMFINZI

    • Drug: Cisplatin
    Chemotherapy

    Drug: Carboplatin
    Chemotherapy

    Drug: Etoposide
    Chemotherapy

    Outcome Measures

    Primary Outcome Measures

    1. Observed serum concentration (Ctrough) [Approximately 16 months]

    2. Number of patients with injection site reactions and immune-mediated reactions [Approximately 16 months]

    3. Maximum observed serum concentration (Cmax) [Approximately 16 months]

    Secondary Outcome Measures

    1. Time to maximum observed serum concentration (tmax) of durvalumab [Approximately 16 months]

    2. Area under the Plasma Concentration versus Time Curve (AUCĪ„) of durvalumab [Approximately 16 months]

    3. Incidence of Adverse Events [Approximately 16 months]

    4. Changes in WHO/ECOG performance status [Approximately 16 months]

    5. Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals [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 [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 [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) [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 [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 [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 [Approximately 16 months]

    12. Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies [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 [Approximately 16 months]

    14. Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug [Approximately 16 months]

    Other Outcome Measures

    1. Incidence of injection site reactions reported through ISQ Symptoms questionnaire [Approximately 16 months]

    2. Treatment satisfaction reported using ISQ Satisfaction questionnaire [Approximately 16 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Tucson Arizona United States 85704
    2 Research Site Tucson Arizona United States 85711
    3 Research Site Augusta Georgia United States 30912
    4 Research Site Lexington Kentucky United States 40536
    5 Research Site Billings Montana United States 59101
    6 Research Site Houston Texas United States 77090
    7 Research Site Fairfax Virginia United States 22031
    8 Research Site Porto Alegre Brazil 90035-903
    9 Research Site Christchurch New Zealand 8011
    10 Research Site Singapore Singapore 119228
    11 Research Site Singapore Singapore 169610
    12 Research Site Singapore Singapore 308433
    13 Research Site Badalona Spain 08916
    14 Research Site Madrid Spain 28041
    15 Research Site Majadahonda Spain 28222
    16 Research Site Sevilla Spain 41009
    17 Research Site Taichung Taiwan 40705
    18 Research Site Taipei City Taiwan 11217
    19 Research Site Taipei City Taiwan 114
    20 Research Site Taipei Taiwan 235
    21 Research Site Ankara Turkey 06340

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Suli Bolus, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04870112
    Other Study ID Numbers:
    • D9072C00001
    • 2020-006041-18
    First Posted:
    May 3, 2021
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Small Cell Lung Carcinoma
    Carboplatin
    Etoposide
    Durvalumab

    Study Results

    No Results Posted as of Aug 4, 2022