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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511887-10-00
Acronym
D6132C00001
Enrollment
3
Registered
2024-07-16
Start date
2021-09-14
Completion date
Unknown
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-line patients with extensive disease small-cell lung cancer (SCLC)

Brief summary

Maintenance participants alive and progression free (APF12)

Detailed description

Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18), Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1, Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1, Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1, Overall survival (OS) in maintenance participants, The safety and tolerability profile of study intervention in SCLC, The pharmacokinetics of durvalumab and AZD2811, Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13

Interventions

DRUGDefosbarasertib
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Maintenance participants alive and progression free (APF12)

Secondary

MeasureTime frame
Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18), Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1, Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1, Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1, Overall survival (OS) in maintenance participants, The safety and tolerability profile of study intervention in SCLC, The pharmacokinetics of durvalumab and AZD2811, Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026