Non-Small Cell Lung Cancer Clinical Trial
— SCope-D1Official 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
Verified date | February 2024 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 18 |
Est. completion date | August 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
New Zealand | Research Site | Christchurch | |
Spain | Research Site | Badalona | |
Spain | Research Site | Majadahonda | |
Taiwan | Research Site | Taichung | |
Taiwan | Research Site | Taipei City | |
Taiwan | Research Site | Taipei City | |
United States | Research Site | Fairfax | Virginia |
United States | Research Site | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, New Zealand, Spain, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of injection site reactions reported through ISQ Symptoms questionnaire | Approximately 16 months | ||
Other | Treatment satisfaction reported using ISQ Satisfaction questionnaire | Approximately 16 months | ||
Primary | Observed serum concentration (Ctrough) | Approximately 16 months | ||
Primary | Number of patients with injection site reactions and immune-mediated reactions | Approximately 16 months | ||
Primary | Maximum observed serum concentration (Cmax) | Approximately 16 months | ||
Secondary | Time to maximum observed serum concentration (tmax) of durvalumab | Approximately 16 months | ||
Secondary | Area under the Plasma Concentration versus Time Curve (AUCt) of durvalumab | Approximately 16 months | ||
Secondary | Incidence of Adverse Events | Approximately 16 months | ||
Secondary | Changes in WHO/ECOG performance status | Approximately 16 months | ||
Secondary | Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals | Approximately 16 months | ||
Secondary | Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry | 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) | Approximately 16 months | |
Secondary | Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology | Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count. | Approximately 16 months | |
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies | Approximately 16 months | ||
Secondary | 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 | ||
Secondary | Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug | Approximately 16 months |
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