MedPath

Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1428935-60-7
Unique Ingredient Identifier
28X28X9OKV
Background

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.

Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Indication

Durvalumab is indicated for the treatment of adults with the following conditions:

Associated Conditions
Extensive-stage Small Cell Lung Cancer (SCLC), Locally Advanced Biliary Tract Cancer, Metastatic Biliary Tract Cancer, Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC), Unresectable Stage III Non-small Cell Lung Cancer, Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
Associated Therapies
First Line Chemotherapy

Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer

Phase 2
Recruiting
Conditions
Nonsmall Cell Lung Cancer Stage III
Unresectable Non-Small Cell Lung Carcinoma
Nonsmall Cell Lung Cancer, Stage II
Interventions
Drug: Durvalumab
Other: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Diagnostic Test: COPD Assessment Test (CAT)
Diagnostic Test: Modified Medical Research Council (mMRC) dyspnea scale
First Posted Date
2023-01-25
Last Posted Date
2024-11-13
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
28
Registration Number
NCT05696782
Locations
🇺🇸

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

First Posted Date
2023-01-18
Last Posted Date
2024-12-02
Lead Sponsor
AstraZeneca
Target Recruit Count
1350
Registration Number
NCT05687266
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.

Active, not recruiting
Conditions
Small Cell Lung Carcinoma
First Posted Date
2023-01-13
Last Posted Date
2024-10-15
Lead Sponsor
AstraZeneca
Target Recruit Count
254
Registration Number
NCT05683977
Locations
🇫🇷

Research Site, Évreux, France

Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk

Phase 2
Recruiting
Conditions
Intrahepatic Cholangiocarcinoma
Gemcis
Durvalumab
Interventions
First Posted Date
2023-01-05
Last Posted Date
2023-01-05
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Target Recruit Count
70
Registration Number
NCT05672537
Locations
🇨🇳

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China

Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio

Phase 2
Recruiting
Conditions
Bile Duct Cancer
Cholangiocarcinoma
Cholangiocarcinoma Non-resectable
Metastatic Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma Metastatic
Interventions
First Posted Date
2022-12-19
Last Posted Date
2024-02-16
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
30
Registration Number
NCT05655949
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Phase 2
Recruiting
Conditions
Resectable Biliary Tract Cancer
Interventions
First Posted Date
2022-12-07
Last Posted Date
2022-12-07
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Target Recruit Count
40
Registration Number
NCT05640791
Locations
🇨🇳

Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, China

REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)

Phase 2
Recruiting
Conditions
Lung Cancer
Interventions
Drug: NKTR-255
Drug: Durvalumab
First Posted Date
2022-12-01
Last Posted Date
2024-11-25
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
39
Registration Number
NCT05632809
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Phase 3
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-11-29
Last Posted Date
2024-12-20
Lead Sponsor
AstraZeneca
Target Recruit Count
1075
Registration Number
NCT05629585
Locations
🇬🇧

Research Site, Taunton, United Kingdom

Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer

Phase 3
Recruiting
Conditions
Locally Advanced Lung Non-Small Cell Carcinoma
Stage IIB Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Interventions
Drug: Carboplatin
Drug: Cisplatin
Procedure: Computed Tomography
Biological: Durvalumab
Drug: Etoposide
Radiation: Image Guided Radiation Therapy
Drug: Paclitaxel
Drug: Pemetrexed
Procedure: Positron Emission Tomography
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Radiation: Stereotactic Body Radiation Therapy
First Posted Date
2022-11-22
Last Posted Date
2024-11-28
Lead Sponsor
NRG Oncology
Target Recruit Count
474
Registration Number
NCT05624996
Locations
🇺🇸

UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States

🇺🇸

Ascension Borgess Hospital, Kalamazoo, Michigan, United States

🇺🇸

Benefis Sletten Cancer Institute, Great Falls, Montana, United States

and more 335 locations

Ph2 Study of Savolitinib and Durvalumab (MEDI4736) Combination in Advanced MET Amplified Gastric Cancer(VIKTORY-2)

Phase 2
Recruiting
Conditions
Stomach Cancer, Adenocarcinoma
Interventions
First Posted Date
2022-11-17
Last Posted Date
2023-01-11
Lead Sponsor
Jeeyun Lee
Target Recruit Count
25
Registration Number
NCT05620628
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

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