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.
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
| Drug | Synonyms | Arms |
|---|
| Durvalumab | MEDI4736, IMFINZI | Patients with NSCLC |
| Cisplatin | | Patients with SCLC |
| Carboplatin | | Patients with SCLC |
| Etoposide | | Patients 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
| Name | Type | Description | Interventions |
|---|
| Patients with NSCLC | Experimental | Patients with Non-Small Cell Lung Cancer | |
| Patients with SCLC | Experimental | Patients 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: | Recruiting |
| Lead Sponsor: | AstraZeneca |
Trial Keywords
Last Updated
August 17, 2021
