Clinical trial NCT04870112: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Keywords: imfinzi
durvalumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.


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

Primary outcomes:
measure: Observed serum concentration (Ctrough)
timeFrame: Approximately 16 months
measure: Number of patients with injection site reactions and immune-mediated reactions
timeFrame: Approximately 16 months
measure: Maximum observed serum concentration (Cmax)
timeFrame: Approximately 16 months
Secondary outcomes:
measure: Time to maximum observed serum concentration (tmax) of durvalumab
timeFrame: Approximately 16 months
measure: Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab
timeFrame: Approximately 16 months
measure: Incidence of Adverse Events
timeFrame: Approximately 16 months
measure: Changes in WHO/ECOG performance status
timeFrame: Approximately 16 months
measure: Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
timeFrame: Approximately 16 months
measure: Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry
timeFrame: Approximately 16 months
measure: Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology
timeFrame: Approximately 16 months
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)
timeFrame: Approximately 16 months
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
timeFrame: Approximately 16 months
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
timeFrame: Approximately 16 months
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
timeFrame: Approximately 16 months
measure: Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
timeFrame: Approximately 16 months
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
timeFrame: Approximately 16 months
measure: Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
timeFrame: Approximately 16 months
Other outcomes:
measure: Incidence of injection site reactions reported through ISQ Symptoms questionnaire
timeFrame: Approximately 16 months
measure: Treatment satisfaction reported using ISQ Satisfaction questionnaire
timeFrame: Approximately 16 months
Locations:
city: Houston
country: United States
facility: Research Site
state: Texas
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Christchurch
country: New Zealand
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Suli Bolus, MD
role: STUDY_DIRECTOR
References: