Study of AZD2811 + Durvalumab in ES-SCLC
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Small-Cell Lung Cancer
Age (in years)
18 - 130
Phase
Phase 2
Participants needed
31
Est. Completion Date
Mar 31, 2023
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT04745689
Study number
D6132C00001
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