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

NCT04870112 | Terminated Phase 1 FDA Drug

• 2 other identifiers: D9072C000012020-006041-18
• Study Type: interventional
• Target: 18
• Locations: 4 countries
• Sites: 8

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.

Conditions

Non-Small Cell Lung Cancer; Small Cell Lung Cancer

Keywords

imfinzi; durvalumab

Outcome Measures

Primary Outcomes (3)

• Observed serum concentration (Ctrough)

  Approximately 16 months

• Number of patients with injection site reactions and immune-mediated reactions

  Approximately 16 months

• Maximum observed serum concentration (Cmax)

  Approximately 16 months

Secondary Outcomes (14)

• Time to maximum observed serum concentration (tmax) of durvalumab

  Approximately 16 months

• Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab

  Approximately 16 months

• Incidence of Adverse Events

  Approximately 16 months

• Changes in WHO/ECOG performance status

  Approximately 16 months

• Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals

  Approximately 16 months

Other Outcomes (2)

• Incidence of injection site reactions reported through ISQ Symptoms questionnaire

  Approximately 16 months

• Treatment satisfaction reported using ISQ Satisfaction questionnaire

  Approximately 16 months

Study Arms (2)

Patients with NSCLC

EXPERIMENTAL

Patients with Non-Small Cell Lung Cancer

Drug: Durvalumab

Patients with SCLC

EXPERIMENTAL

Patients with Small Cell Lung Cancer

Drug: Durvalumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide

Interventions

Durvalumab DRUG

Anti-PD-L1 antibody

Also known as: MEDI4736, IMFINZI

Patients with NSCLC; Patients with SCLC

Cisplatin DRUG

Chemotherapy

Patients with SCLC

Carboplatin DRUG

Chemotherapy

Patients with SCLC

Etoposide DRUG

Chemotherapy

Patients with SCLC

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Houston, Texas, 77090, United States

Location

Research Site

Fairfax, Virginia, 22031, United States

Location

Research Site

Christchurch, 8011, New Zealand

Location

Research Site

Badalona, 08916, Spain

Location

Research Site

Majadahonda, 28222, Spain

Location

Research Site

Taichung, 40705, Taiwan

Location

Research Site

Taipei, 11217, Taiwan

Location

Research Site

Taipei, 114, Taiwan

Location

Related Links

• AstraZenecaClinicaltrials.com

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

durvalumab; Cisplatin; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Suli Bolus, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 3, 2021
• Study Start: June 28, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: April 17, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (2); NZ (1); ES (2); TW (3)