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

Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy

First Posted Date
2022-02-03
Last Posted Date
2024-01-17
Lead Sponsor
Asan Medical Center
Target Recruit Count
62
Registration Number
NCT05222971
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

First Posted Date
2022-02-03
Last Posted Date
2024-12-09
Lead Sponsor
AstraZeneca
Target Recruit Count
999
Registration Number
NCT05221840
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)

First Posted Date
2022-01-31
Last Posted Date
2024-07-08
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
200
Registration Number
NCT05215106
Locations
🇫🇷

Gustave Roussy, Villejuif, France

🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

Centre Léon Berard, Lyon, France

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

First Posted Date
2022-01-27
Last Posted Date
2024-11-25
Lead Sponsor
AstraZeneca
Target Recruit Count
860
Registration Number
NCT05211895
Locations
🇬🇧

Research Site, Nottingham, United Kingdom

Window of Opportunity Trial of Durvalumab (MEDI4736) to Identify Immune Dynamics in Operable Non-small Cell Lung Cancer (NSCLC) (MIRACLE)

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2022-01-25
Last Posted Date
2022-02-11
Lead Sponsor
Yonsei University
Target Recruit Count
25
Registration Number
NCT05206812
Locations
🇰🇷

Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

First Posted Date
2022-01-20
Last Posted Date
2024-12-13
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
42
Registration Number
NCT05198830
Locations
🇺🇸

Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States

🇺🇸

Keck Medicine of USC Buena Park, Buena Park, California, United States

🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

and more 19 locations

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

First Posted Date
2021-12-27
Last Posted Date
2024-11-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
121
Registration Number
NCT05170204
Locations
🇮🇳

Medanta-The Medicity, Gurgaon, Haryana, India

🇹🇷

Dicle University Faculty of Medicine, Diyarbakir, Turkey

🇺🇸

University of South Alabama; Mitchell Cancer Institute, Mobile, Alabama, United States

and more 167 locations

Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC

First Posted Date
2021-12-15
Last Posted Date
2021-12-15
Lead Sponsor
Juan LI, MD
Target Recruit Count
9
Registration Number
NCT05157542
Locations
🇨🇳

Sichuan Cancer Hospital, Chengdu, Sichuan, China

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