Status:
ACTIVE_NOT_RECRUITING
Study of AZD2811 + Durvalumab in ES-SCLC
Lead Sponsor:
AstraZeneca
Conditions:
Small-Cell Lung Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief 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...
Detailed Description
Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in patients who have not progressed following induction therapy with platinum-based chemotherapy combined with dur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04745689
Start Date
February 23 2021
End Date
December 1 2026
Last Update
December 10 2025
Active Locations (12)
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1
Research Site
Grand Rapids, Michigan, United States, 49503
2
Research Site
Bydgoszcz, Poland, 85-796
3
Research Site
Olsztyn, Poland, 10-357
4
Research Site
Poznan, Poland, 60-693