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 of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Olomorasib
Drug: Pembrolizumab
Drug: Placebo
Drug: Durvalumab

First Posted Date: 2025-03-24

Last Posted Date: 2025-04-23

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 700

Registration Number: NCT06890598

Locations: 🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸
The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States

and more 318 locations

STRIDE (durvalumab + Tremelimumab) with Lenvatinib Vs STRIDE Alone in Unresectable Hepatocellular Carcinoma

Phase 2

Not yet recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: STRIDE (durvalumab + tremelimumab)
Drug: Durvalumab
Drug: Lenvatinib

First Posted Date: 2025-03-17

Last Posted Date: 2025-03-17

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 140

Registration Number: NCT06880523

HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma

Phase 2

Not yet recruiting

Conditions: Advanced Intrahepatic Cholangiocarcinoma

Interventions: Drug: Durvalumab
Drug: Gemcitabine
Drug: Cisplatin

First Posted Date: 2025-03-05

Last Posted Date: 2025-03-05

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 60

Registration Number: NCT06858735

Locations: 🇺🇸
The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States

REAL-WORLD DURVALUMAB IN EXTENSIVE-STAGE SMALL CELL LUNG CANCER

Recruiting

Conditions: Small Cell Lung Carcinoma

First Posted Date: 2025-02-14

Last Posted Date: 2025-04-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 90

Registration Number: NCT06826677

Locations: 🇮🇹
Research Site, Vimercate, Italy

ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma W/ARID1a Mu

Early Phase 1

Not yet recruiting

Conditions: Solid Tumor, Adult
Malignant Solid Tumor
Stomach Adenocarcinoma
Esophageal Adenocarcinoma

Interventions: Drug: Tremelimumab
Drug: Durvalumab

First Posted Date: 2025-02-13

Last Posted Date: 2025-02-13

Lead Sponsor: University of California, Irvine

Target Recruit Count: 34

Registration Number: NCT06824363

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States

BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)

Phase 2

Recruiting

Conditions: Limited Stage Small Cell Lung Cancer

Interventions: Drug: Durvalumab
Drug: BMS-986489

First Posted Date: 2025-01-14

Last Posted Date: 2025-05-07

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 250

Registration Number: NCT06773910

Locations: 🇺🇸
Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center, Columbus, Ohio, United States
🇺🇸
Virginia Cancer Specialists, Fairfax, Virginia, United States
🇺🇸
Virginia Oncology Associates, Norfolk, Virginia, United States

and more 13 locations

A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Advanced or Recurrent Endometrial Cancer in Spain

Phase 3

Recruiting

Conditions: Advanced or Recurrent Endometrial Cancer

Interventions: Drug: Durvalumab + Chemotherapy phase
Drug: Durvalumab + Olaparib phase

First Posted Date: 2024-12-24

Last Posted Date: 2025-05-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 85

Registration Number: NCT06746116

Locations: 🇪🇸
Research Site, Zaragoza, Spain

Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer

Phase 3

Not yet recruiting

Conditions: Lung Non-Small Cell Carcinoma
Stage IIIB Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Ceralasertib
Biological: Durvalumab
Procedure: Echocardiography Test

First Posted Date: 2024-12-13

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 630

Registration Number: NCT06732401

A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement

Phase 2

Not yet recruiting

Conditions: Intrahepatic Cholangiocarcinoma
FGFR2 Gene Rearrangement
FGFR2 Gene Mutation

Interventions: Drug: Pemigatinib
Drug: Durvalumab

First Posted Date: 2024-12-11

Last Posted Date: 2025-05-02

Lead Sponsor: Mehmet Akce

Target Recruit Count: 38

Registration Number: NCT06728410

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

Cryoablation and Arterial Infusion of SD-101 in Combination with Durvalumab and Tremelimumab

Phase 1

Recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: SD-101
Device: Cryotherapy
Drug: Tremelimumab
Drug: Durvalumab

First Posted Date: 2024-11-29

Last Posted Date: 2025-02-11

Lead Sponsor: University of California, San Diego

Target Recruit Count: 20

Registration Number: NCT06710223

Locations: 🇺🇸
University of California, San Diego, San Diego, California, United States

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