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

Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents

Phase 1

Recruiting

Conditions: Bladder Cancer

Interventions: Drug: Romidepsin
Drug: Durvalumab

First Posted Date: 2025-05-09

Last Posted Date: 2025-05-09

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 12

Registration Number: NCT06963346

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

Phase 3

Not yet recruiting

Conditions: Urinary Bladder Neoplasms
Immune Checkpoint Inhibitors
Methotrexate
Vinblastine
Doxorubicin
Cisplatin
Gemcitabine

Interventions: Drug: Durvalumab
Drug: Methotrexate
Drug: Gemcitabine
Drug: Vinblastine
Drug: Doxorubicin
Drug: Cisplatin

First Posted Date: 2025-05-07

Last Posted Date: 2025-05-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 150

Registration Number: NCT06960577

Locations: 🇪🇸
Research Site, Santiago de Compostela, Spain

Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer

Phase 2

Not yet recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Datopotamab Deruxtecan (Dato-DXd)
Drug: Durvalumab

First Posted Date: 2025-05-01

Last Posted Date: 2025-05-01

Lead Sponsor: Queen Mary University of London

Target Recruit Count: 140

Registration Number: NCT06954480

Locations: 🇬🇧
Barts Cancer Institute, Centre of Experimental Cancer Medicine, London, United Kingdom

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )

Phase 1

Recruiting

Conditions: Small Cell Lung Cancer Extensive Stage
Merkel Cell Carcinoma

Interventions: Drug: 225Ac-SSO110 + SoC
Drug: Atezolizumab
Drug: Durvalumab
Drug: Avelumab
Drug: Pembrolizumab
Drug: Retifanlimab

First Posted Date: 2025-04-22

Last Posted Date: 2025-04-22

Lead Sponsor: Ariceum Therapeutics GmbH

Target Recruit Count: 50

Registration Number: NCT06939036

Locations: 🇺🇸
Biogenix Molecular, Miami, Florida, United States

Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab

Phase 4

Recruiting

Conditions: Non-small Cell Lung Cancer Stage III

Interventions: Drug: Consolidation durvalumab

First Posted Date: 2025-04-03

Last Posted Date: 2025-04-03

Lead Sponsor: Idris Bahce

Target Recruit Count: 38

Registration Number: NCT06908070

Locations: 🇳🇱
Amsterdam UMC, location VU Medical center, Amsterdam, Netherlands

Durvalumab and Tremelimumab With or Without Hepatic Arterial Infusion of Chemotherapy in Hepatocellular Carcinoma

Phase 2

Not yet recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Durvalumab Plus Tremelimumab
Drug: HAIC (GEMOX)

First Posted Date: 2025-04-01

Last Posted Date: 2025-04-01

Lead Sponsor: UNICANCER

Target Recruit Count: 196

Registration Number: NCT06904170

Locations: 🇫🇷
CHU de Bordeaux, Bordeaux, France
🇫🇷
AP-HP Hôpital Beaujon, Clichy, France
🇫🇷
CHU Hôtel-Dieu, Nantes, France

and more 7 locations

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

Phase 1

Recruiting

Conditions: Small Cell Lung Cancer

Interventions: Drug: YL201
Drug: Tarlatamab
Drug: Atezolizumab
Drug: Durvalumab

First Posted Date: 2025-03-27

Last Posted Date: 2025-05-14

Lead Sponsor: Amgen

Target Recruit Count: 200

Registration Number: NCT06898957

Locations: 🇺🇸
Washington University, Saint Louis, Missouri, United States
🇨🇳
Shandong Cancer Hospital, Jinan, Shandong, China

A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma

Phase 2

Not yet recruiting

Conditions: Combined Hepatocellular and Cholangiocarcinoma

Interventions: Drug: Tremelimumab
Drug: Durvalumab
Drug: Gemcitabine
Drug: Cisplatin

First Posted Date: 2025-03-25

Last Posted Date: 2025-03-28

Lead Sponsor: Mehmet Akce

Target Recruit Count: 29

Registration Number: NCT06855225

Hepatic Arterial Infusion Chemotherapy (HAIC) Combined with Durvalumab and Lenvatinib in Patients with Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)

Phase 2

Recruiting

Conditions: Intrahepatic Cholangiocarcinoma (Icc)
HAIC
Durvalumab

Interventions: Drug: Durvalumab
Drug: hepatic arterial infusion chemotherapy (HAIC)
Drug: Lenvatinib

First Posted Date: 2025-03-25

Last Posted Date: 2025-03-28

Lead Sponsor: West China Hospital

Target Recruit Count: 25

Registration Number: NCT06859684

Locations: 🇨🇳
West China Hospital, Sichuan University, Chengdu, Sichuan, China

Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study

Phase 2

Not yet recruiting

Conditions: Lung Small Cell Carcinoma, I Subtype
Lung Small Cell Carcinoma, N Subtype
Lung Small Cell Carcinoma, P Subtype
Extensive Stage Lung Small Cell Carcinoma
Lung Small Cell Carcinoma, A Subtype

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Ceralasertib
Biological: Durvalumab
Drug: Etoposide
Procedure: Magnetic Resonance Imaging
Drug: Platinum Compound
Biological: Monalizumab
Procedure: Positron Emission Tomography
Radiation: Thoracic Radiation Therapy
Drug: Saruparib

First Posted Date: 2025-03-25

Last Posted Date: 2025-03-28

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 900

Registration Number: NCT06769126

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