Clinical Trials /

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

NCT04870112

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: D9072C00001
  • SECONDARY ID: 2020-006041-18
  • NCT ID: NCT04870112

Conditions

  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
DurvalumabMEDI4736, IMFINZIPatients with NSCLC
CisplatinPatients with SCLC
CarboplatinPatients with SCLC
EtoposidePatients with SCLC

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Patients with NSCLCExperimentalPatients with Non-Small Cell Lung Cancer
  • Durvalumab
Patients with SCLCExperimentalPatients with Small Cell Lung Cancer
  • Durvalumab
  • Cisplatin
  • Carboplatin
  • Etoposide

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

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Observed serum concentration (Ctrough)
Time Frame:Approximately 16 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Time to maximum observed serum concentration (tmax) of durvalumab
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Incidence of Adverse Events
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Changes in WHO/ECOG performance status
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure: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
Safety Issue:
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)
Measure: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
Safety Issue:
Description:Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
Measure: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 Issue:
Description:
Measure: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 Issue:
Description:
Measure: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 Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
Time Frame:Approximately 16 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • imfinzi
  • durvalumab

Last Updated

May 3, 2021