Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in South Korea / NCT04745689
Active, not recruiting Phase 2

Study of AZD2811 + Durvalumab in ES-SCLC

NCT04745689 · tracked via the Priya Life Science South Korea tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2021-02-23
Last updated
2026-07-06

Condition(s) studied

Small-Cell Lung Cancer

Investigational drug(s) / intervention(s)

Durvalumab →AZD2811Carboplatin →Cisplatin →Etoposide →

Durvalumab: IV infusions through induction phase. IV infusions through maintenance phase until PD or other discontinuation criteria.

AZD2811: IV infusions through maintenance phase until PD or other discontinuation criteria.

Carboplatin: IV infusions through induction phase if chosen by Investigator.

Cisplatin: IV infusions through induction phase if chosen by Investigator.

Etoposide: IV infusions through induction phase.

Study summary

A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Documented evidence of extensive stage SCLC (ES-SCLC) * Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC * No prior exposure to immune-mediated therapy * Life expectancy ≥12 weeks at Day 1. * ECOG 0 or 1 at enrolment. Exclusion Criteria: * Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy * Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS * Active infection including tuberculosis, HIV, hepatitis B and C * Active or prior documented autoimmune or inflammatory disorders * Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.

Primary outcome measure(s)

  • Maintenance Participants Alive and Progression Free (APF12) Per RECIST 1.1 [Efficacy] — Up to 12 months
    12 month landmark PFS, APF12, where PFS is defined as the time from the first dose of study intervention in the induction phase until objective disease progression (as assessed by the investigator per RECIST v1.1) or death from any cause, whichever comes first.

Trial sites (12)

FacilityCityRegionStatus
Research Site Grand Rapids Michigan
Research Site Bydgoszcz Poland
Research Site Olsztyn Poland
Research Site Poznan Poland
Research Site Cheongju-si South Korea
Research Site Jinju South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seville Spain
Research Site Valencia Spain

On this site

📄 Imfinzi (durvalumab) drug profile →

More AstraZeneca trials in South Korea

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Recruiting
A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH Active, not recruiting
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer Recruiting
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer Active, not recruiting
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab Recruiting

Other trials for the same condition

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab Active, not recruiting
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer Active, not recruiting
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy Active, not recruiting
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04745689 on ClinicalTrials.gov ↗ ← All trials in South Korea