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

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Phase 3

Recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Adjuvant durvalumab

First Posted Date: 2024-02-28

Last Posted Date: 2025-05-09

Lead Sponsor: ETOP IBCSG Partners Foundation

Target Recruit Count: 290

Registration Number: NCT06284317

Locations: 🇦🇺
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
🇦🇺
Nepean Hospital, Penrith, New South Wales, Australia
🇦🇺
Royal North Shore Hospital, St Leonards, New South Wales, Australia

and more 39 locations

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

Phase 3

Recruiting

Conditions: Biliary Tract Cancer

Interventions: Drug: Zanidatamab
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pembrolizumab
Drug: Durvalumab

First Posted Date: 2024-02-28

Last Posted Date: 2025-05-13

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 286

Registration Number: NCT06282575

Locations: 🇵🇹
Champalimaud Clinical Center, Lisboa, Portugal
🇵🇹
Instituto Português de Oncologia Do Porto Francisco Gentil, EPE, Porto, Portugal
🇷🇴
Centrul de Oncologie Euroclinic SRL, Iasi, Romania

and more 160 locations

Futibatinib in Combination with Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

Phase 2

Recruiting

Conditions: Bladder Urothelial Carcinoma
Muscle Invasive Bladder Carcinoma
Stage II Bladder Cancer AJCC V8
Stage IIIA Bladder Cancer AJCC V8

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Durvalumab
Drug: Futibatinib
Procedure: Magnetic Resonance Imaging
Procedure: Radical Cystectomy

First Posted Date: 2024-02-16

Last Posted Date: 2025-01-03

Lead Sponsor: Yuanquan Yang

Target Recruit Count: 24

Registration Number: NCT06263153

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

Phase 1

Not yet recruiting

Conditions: Biliary Tract Cancer

Interventions: Drug: Surufatinib
Drug: Durvalumab

First Posted Date: 2024-02-13

Last Posted Date: 2024-02-13

Lead Sponsor: China Medical University, China

Target Recruit Count: 30

Registration Number: NCT06255262

Locations: 🇨🇳
Anshan Cancer Hospital, Anshan, Liaoning, China
🇨🇳
The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China
🇨🇳
First Hospital of China Medical University, Shenyang, Liaoning, China

and more 1 locations

Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection

Phase 2

Withdrawn

Conditions: Hepatitis B, Chronic

Interventions: Drug: Imdusiran
Drug: Durvalumab

First Posted Date: 2024-02-07

Last Posted Date: 2024-08-12

Lead Sponsor: Arbutus Biopharma Corporation

Registration Number: NCT06245291

Locations: 🇨🇳
China Medical University Hospital, Taichung City, Taiwan
🇹🇭
The Hiv Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand
🇨🇳
Chia-yi Christian Hospital, Chia-Yi City, Taiwan

and more 18 locations

Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC

Phase 2

Recruiting

Conditions: Extensive-stage Small-cell Lung Cancer

Interventions: Radiation: Thoracic Radiochemotherapy
Drug: durvalumab
Radiation: Stereotactic radiotherapy of further tumor locations
Drug: Chemotherapy

First Posted Date: 2024-01-25

Last Posted Date: 2024-04-05

Lead Sponsor: Universität des Saarlandes

Target Recruit Count: 43

Registration Number: NCT06223711

Locations: 🇩🇪
Kliniken Maria Hilf, Mönchengladbach, NRW, Germany
🇩🇪
Saarland University Medical Center and Saarland University Faculty of Medicine, Clinic for Radiotherapy and Radiooncology, Homburg, Saarland, Germany
🇩🇪
University Hospital Regensburg, Clinic and Polyclinic for Radiotherapy, Regensburg, Bavaria, Germany

and more 2 locations

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

Phase 3

Recruiting

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

Interventions: Drug: Tarlatamab
Drug: Durvalumab

First Posted Date: 2024-01-18

Last Posted Date: 2025-05-14

Lead Sponsor: Amgen

Target Recruit Count: 550

Registration Number: NCT06211036

Locations: 🇩🇰
Odense Universitetshospital, Odense C, Denmark
🇰🇷
Severance Hospital Yonsei University Health System, Seoul, Korea, Republic of
🇨🇳
Jiamusi Cancer Hospital, Jiamusi, Heilongjiang, China

and more 215 locations

--SuPERIOR Trial--

Phase 2

Terminated

Conditions: Clinical Staging T2b-3 N0-1 M0
Non-Small Cell Lung Cancer (NSCLC)

Interventions: Drug: Durvalumab
Radiation: Non-ablative oligofractionated radiation (NORT)

First Posted Date: 2024-01-05

Last Posted Date: 2025-02-03

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 10

Registration Number: NCT06191250

Locations: 🇨🇦
University Health Network, Toronto, Ontario, Canada

Tumor Treating Fields for Locally Advanced NSCLC

Phase 1

Recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Device: NovoTTF-200T (TTFields) System
Radiation: carboplatin chemotherapy
Drug: Durvalumab

First Posted Date: 2023-11-09

Last Posted Date: 2024-10-07

Lead Sponsor: University of Utah

Target Recruit Count: 30

Registration Number: NCT06124118

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery

Recruiting

Conditions: Unresectable Hepatocellular Carcinoma

Interventions: Drug: Atezolizumab
Drug: Bevacizumab
Drug: Durvalumab
Drug: Tremelimumab,

First Posted Date: 2023-11-07

Last Posted Date: 2025-05-13

Lead Sponsor: Bayer

Target Recruit Count: 300

Registration Number: NCT06117891

Locations: 🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States
🇺🇸
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
🇺🇸
University Of Cincinnati Division Of Hematology Oncology - UC Health System, Cincinnati, Ohio, United States

and more 4 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy