Durvalumab

Generic Name: Durvalumab

Brand Names: Imfinzi

Drug Type: Biotech

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

Clinical Trials

Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma

Phase 1

Recruiting

Conditions: Mesothelioma

Interventions: Drug: Platinum cisplatin or carboplatin and pemetrexed chemotherapy plus durvalumab/tremelimumab
Drug: Durvalumab / tremelimumab

First Posted Date: 2023-07-06

Last Posted Date: 2024-08-26

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 52

Registration Number: NCT05932199

Locations: 🇺🇸
Baylor St Lukes, Houston, Texas, United States
🇺🇸
Duke Cancer Institute, Durham, North Carolina, United States

RELEVANCE - RWE Study in Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Durvalumab

First Posted Date: 2023-07-06

Last Posted Date: 2023-09-05

Lead Sponsor: AstraZeneca

Target Recruit Count: 662

Registration Number: NCT05933044

Locations: 🇨🇦
Queen Elizabeth (QE) II Health Sciences Centre, Halifax, Nova Scotia, Canada
🇨🇦
The Ottawa Hospital, Ottawa, Ontario, Canada
🇨🇦
University of Calgary, Calgary, Alberta, Canada

and more 2 locations

Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy

Phase 1

Recruiting

Conditions: Metastatic Pancreatic Cancer

Interventions: Biological: Durvalumab
Drug: Rintatolimod

First Posted Date: 2023-07-03

Last Posted Date: 2025-02-25

Lead Sponsor: Joachim Aerts, MD PhD

Target Recruit Count: 43

Registration Number: NCT05927142

Locations: 🇳🇱
Erasmus MC, Rotterdam, Zuid-Holland, Netherlands

A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)

Phase 3

Completed

Conditions: Biliary Tract Cancers

Interventions: Drug: durvalumab

First Posted Date: 2023-06-29

Last Posted Date: 2025-04-22

Lead Sponsor: AstraZeneca

Target Recruit Count: 116

Registration Number: NCT05924880

Locations: 🇨🇳
Research Site, Xiamen, China

Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Durvalumab

First Posted Date: 2023-06-29

Last Posted Date: 2025-05-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 140

Registration Number: NCT05925530

Locations: 🇸🇪
Research Site, Uppsala, Sweden

Abequolixron (RGX-104) and Durvalumab in Lung Cancer

Phase 1

Terminated

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Durvalumab
Drug: Carboplatin
Drug: Abequolixron
Drug: Abraxane
Drug: Pemetrexed

First Posted Date: 2023-06-22

Last Posted Date: 2025-03-21

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 1

Registration Number: NCT05911308

Locations: 🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Small Cell Lung Cancer
SCLC
Extensive Stage Small Cell Lung Cancer

Interventions: Drug: Durvalumab
Drug: Monalizumab
Drug: Carboplatin or Cisplatin
Drug: Etoposide

First Posted Date: 2023-06-15

Last Posted Date: 2025-05-04

Lead Sponsor: Hirva Mamdani

Target Recruit Count: 38

Registration Number: NCT05903092

Locations: 🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
🇺🇸
Karmanos Cancer Center (Wayne State University), Detroit, Michigan, United States

and more 1 locations