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 Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax

Phase 2

Recruiting

Conditions: Small Cell Lung Carcinoma

Interventions: Drug: Durvalumab

First Posted Date: 2022-11-16

Last Posted Date: 2024-05-08

Lead Sponsor: UNICANCER

Target Recruit Count: 550

Registration Number: NCT05617963

Locations: 🇫🇷
Institut du Cancer Avignon-Provence, Avignon, France
🇫🇷
Centre d'Oncologie du Pays Basque, Bayonne, France
🇫🇷
CH de la côte Basque, Bayonne, France

and more 34 locations

Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer Metastatic

Interventions: Drug: Ceralasertib
Drug: Durvalumab
Drug: Nab-paclitaxel

First Posted Date: 2022-10-17

Last Posted Date: 2025-05-01

Lead Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology

Target Recruit Count: 37

Registration Number: NCT05582538

Locations: 🇮🇹
ASST Papa Giovanni XXIII, Bergamo, Italy
🇮🇹
IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale", Napoli, Italy
🇮🇹
Azienda U.S.L. - IRCCS di Reggio Emilia, Reggio Emilia, Italy

and more 3 locations

Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab

Phase 2

Recruiting

Conditions: Non-small-cell Lung Cancer Patients

Interventions: Drug: Single-agent chemotherapy
Drug: Durvalumab
Drug: Olaparib tablet
Drug: Platinum doublet chemotherapy

First Posted Date: 2022-10-05

Last Posted Date: 2022-10-05

Lead Sponsor: Fondazione Ricerca Traslazionale

Target Recruit Count: 176

Registration Number: NCT05568212

Locations: 🇮🇹
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena, Roma, RM, Italy

Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma

Phase 3

Recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2022-09-28

Last Posted Date: 2025-02-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 210

Registration Number: NCT05557838

Locations: 🇨🇳
Research Site, Zhengzhou, China

A Study to Evaluate the Safety and Pharmacokinetics of Ceralasertib in Combination With Durvalumab in Chinese Patients With Advanced Solid Tumours

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumours

Interventions: Drug: Ceralasertib
Drug: Durvalumab

First Posted Date: 2022-08-24

Last Posted Date: 2025-02-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 14

Registration Number: NCT05514132

Locations: 🇨🇳
Research Site, Shandong, China

Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment in Extensive Stage Small Cell Lung Cancer With Oligometastases

Phase 2

Not yet recruiting

Conditions: Radiotherapy
Lung Cancer
Extensive-stage Small-cell Lung Cancer

Interventions: Drug: Durvalumab + carboplatin/cisplatin + etoposide
Radiation: Consolidation radiotherapy
Drug: Durvalumab

First Posted Date: 2022-08-02

Last Posted Date: 2022-08-05

Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Target Recruit Count: 58

Registration Number: NCT05484583

A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

Phase 3

Active, not recruiting

Conditions: Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions: Drug: Ceralasertib
Drug: Docetaxel
Drug: Durvalumab

First Posted Date: 2022-07-11

Last Posted Date: 2025-03-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 594

Registration Number: NCT05450692

Locations: 🇬🇧
Research Site, Wirral, United Kingdom

Combining ICI With SBRT or HypoFrx-RT for ES NSCLC

Phase 1

Not yet recruiting

Conditions: Non-small Cell Lung Cancer Stage I
Non-small Cell Lung Cancer Stage III
Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer
Non-small Cell Carcinoma

Interventions: Radiation: Hypofractionated radiotherapy
Radiation: Stereotactic body radiotherapy
Drug: Durvalumab

First Posted Date: 2022-07-11

Last Posted Date: 2023-10-03

Lead Sponsor: Alexander Chi

Target Recruit Count: 83

Registration Number: NCT05451173

Locations: 🇨🇳
Capital Medical University Xuanwu Hospital, Beijing, Beijing, China

Durvalumab and Grid Therapy for Non-small Cell Lung Cancer in Progression During or After Treatment with PACIFIC Regimen

Phase 2

Recruiting

Conditions: Lung Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC V8

Interventions: Biological: Durvalumab
Radiation: Radiation Therapy
Procedure: Biospecimen Collection

First Posted Date: 2022-07-05

Last Posted Date: 2024-12-05

Lead Sponsor: Mayo Clinic

Target Recruit Count: 11

Registration Number: NCT05443971

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer

Phase 1

Recruiting

Conditions: Stage III Pancreatic Cancer AJCC v8
Locally Advanced Pancreatic Carcinoma
Stage II Pancreatic Cancer AJCC v8
Unresectable Pancreatic Carcinoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Biological: Durvalumab
Drug: Olaparib
Radiation: Radiation Therapy
Procedure: Radiologic Examination

First Posted Date: 2022-06-09

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 18

Registration Number: NCT05411094

Locations: 🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 8 locations

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