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

A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer

First Posted Date
2021-05-27
Last Posted Date
2024-06-18
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
41
Registration Number
NCT04905316
Locations
🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Nassau, Uniondale, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 4 locations

Lung Cancer With Copanlisib and Durvalumab

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-05-20
Last Posted Date
2024-02-13
Lead Sponsor
Zhonglin Hao
Target Recruit Count
11
Registration Number
NCT04895579
Locations
🇺🇸

Markey Cancer Center, Lexington, Kentucky, United States

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

First Posted Date
2021-05-03
Last Posted Date
2024-03-08
Lead Sponsor
AstraZeneca
Target Recruit Count
18
Registration Number
NCT04870112
Locations
🇨🇳

Research Site, Taipei City, Taiwan

A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer

First Posted Date
2021-04-29
Last Posted Date
2024-10-31
Lead Sponsor
BeiGene
Target Recruit Count
63
Registration Number
NCT04866017
Locations
🇺🇸

XCancer/Centeral Care Center, Bolivar, Missouri, United States

🇦🇺

Southern Medical Day Care Centre, Wollongong, New South Wales, Australia

🇦🇺

Townsville Hospital, Douglas, Queensland, Australia

and more 29 locations

Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma

First Posted Date
2021-04-20
Last Posted Date
2021-06-22
Lead Sponsor
Chinese Academy of Medical Sciences
Target Recruit Count
33
Registration Number
NCT04851132
Locations
🇨🇳

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC.

First Posted Date
2021-03-26
Last Posted Date
2023-10-31
Lead Sponsor
Gruppo Oncologico del Nord-Ovest
Target Recruit Count
31
Registration Number
NCT04817826
Locations
🇮🇹

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy

Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC

First Posted Date
2021-03-08
Last Posted Date
2024-12-12
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
52
Registration Number
NCT04786093
Locations
🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers

First Posted Date
2021-03-04
Last Posted Date
2024-02-23
Lead Sponsor
University of Kansas Medical Center
Target Recruit Count
40
Registration Number
NCT04781192
Locations
🇺🇸

University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States

🇺🇸

University of Kansas Cancer Center - North, Kansas City, Missouri, United States

🇺🇸

University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States

and more 1 locations
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