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

Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)

Phase 2

Recruiting

Conditions: Pulmonary Large-cell Neuroendocrine Carcinoma

Interventions: Drug: Durvalumab 50 MG/1 ML Intravenous Solution [IMFINZI]

First Posted Date: 2024-05-16

Last Posted Date: 2024-05-16

Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

Target Recruit Count: 49

Registration Number: NCT06418087

Locations: 🇮🇹
Istituto Oncologico del Mediterraneo IOM - Viagrande Catania, Viagrande, CT, Italy
🇮🇹
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. IRCCS, Meldola, FC, Italy
🇮🇹
Azienda Usl Toscana nord ovest Ospedale San Luca, Lucca, Italy

and more 12 locations

FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum

Phase 2

Recruiting

Conditions: Large Cell Neuroendocrine Carcinoma of the Lung

Interventions: Drug: Durvalumab with etoposide and Carboplatin/Cisplatin

First Posted Date: 2024-05-01

Last Posted Date: 2024-08-02

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 80

Registration Number: NCT06393816

Locations: 🇷🇪
Chu Reunion, Réunion, Réunion
🇫🇷
Centre Hospitalier Intercommunal Aix-Pertuis, Aix-en-Provence, France
🇫🇷
Chu Amiens Picardie Site Sud, Amiens, France

and more 28 locations

Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy

Phase 2

Recruiting

Conditions: Intrahepatic Cholangiocarcinoma

Interventions: Radiation: radioembolization with Y-90
Drug: Durvalumab
Drug: Cisplatin
Drug: Gemcitabine

First Posted Date: 2024-04-19

Last Posted Date: 2024-05-24

Lead Sponsor: Francesco De Cobelli

Target Recruit Count: 33

Registration Number: NCT06375915

Locations: 🇮🇹
Department of Radiology, IRCCS Ospedale San Raffaele, Milano, Italy

Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01)

Phase 2

Recruiting

Conditions: SCLC, Limited Stage

Interventions: Drug: Durvalumab
Drug: Chemotherapy drug of EP regimen
Radiation: radiotherapy

First Posted Date: 2024-04-17

Last Posted Date: 2024-06-17

Lead Sponsor: Hebei Medical University Fourth Hospital

Target Recruit Count: 58

Registration Number: NCT06371482

Locations: 🇨🇳
Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma

Phase 2

Recruiting

Conditions: Cholangiocarcinoma

Interventions: Drug: Durvalumab 1120 mg
Drug: Durvalumab 1500 mg
Drug: Tremelimumab i.v. at 300 mg
Combination Product: Cisplatin (CDDP) 25 mg/mq i.v
Combination Product: Gemcitabine (GEM) 1000 mg/mq i.v.

First Posted Date: 2024-04-02

Last Posted Date: 2024-11-07

Lead Sponsor: National Cancer Institute, Naples

Target Recruit Count: 38

Registration Number: NCT06341764

Locations: 🇮🇹
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale, Napoli, Italia, Italy
🇮🇹
Ospedale Cardarelli, Napoli, Napoli, Italia, Italy
🇮🇹
Università di Napoli "Federico II", Napoli, Napoli, Italia, Italy

and more 3 locations

A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Durvalumab
Drug: Sotorasib

First Posted Date: 2024-03-27

Last Posted Date: 2025-04-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 160

Registration Number: NCT06333678

Locations: 🇺🇸
University of Miami (Data Collection Only), Miami, Florida, United States
🇺🇸
University of Michigan (Data Collection Only), Ann Arbor, Michigan, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 8 locations

Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer (NSCLC)
Lung Cancer Patients

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

First Posted Date: 2024-03-26

Last Posted Date: 2024-07-22

Lead Sponsor: Marc de Perrot

Target Recruit Count: 12

Registration Number: NCT06331455

Locations: 🇨🇦
Toronto General Hospital, Toronto, Canada

Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy

Phase 1

Not yet recruiting

Conditions: Locally Advanced Rectal Carcinoma

Interventions: Drug: Imfinzi
Drug: Opdivo

First Posted Date: 2024-03-12

Last Posted Date: 2024-03-12

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 18

Registration Number: NCT06304597

Locations: 🇳🇱
University Medical Center Groningen, Groningen, Netherlands

A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study

Phase 2

Recruiting

Conditions: Esophageal Cancer

Interventions: Drug: Durvalumab

First Posted Date: 2024-03-04

Last Posted Date: 2024-11-04

Lead Sponsor: Australasian Gastro-Intestinal Trials Group

Target Recruit Count: 54

Registration Number: NCT06290505

Locations: 🇦🇺
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
🇦🇺
Border Medical Oncology, Albury, New South Wales, Australia

and more 5 locations

Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer

Phase 1

Recruiting

Conditions: Extensive Stage Lung Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8

Interventions: Biological: Atezolizumab
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Durvalumab
Procedure: Echocardiography Test
Drug: Iadademstat
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan

First Posted Date: 2024-03-01

Last Posted Date: 2025-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT06287775

Locations: 🇺🇸
University of Kansas Clinical Research Center, Fairway, Kansas, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
City of Hope at Irvine Lennar, Irvine, California, United States

and more 25 locations

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