Status:
COMPLETED
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Small Cell Lung Carcinoma Extensive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab ...
Detailed Description
This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will ...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
- Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
- Brain metastases; must be asymptomatic or have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
- Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
- ECOG Performance Status of 0-2 at enrolment.
- No prior exposure to immune-mediated therapy for cancer.
- Adequate hematologic and organ function.
- Life expectancy of at least 12 weeks.
- Body weight \>30 kg.
Exclusion
- Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
- Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
- Active infection including tuberculosis, HIV, hepatitis B anc 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 :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04712903
Start Date
December 16 2020
End Date
June 21 2023
Last Update
January 7 2025
Active Locations (34)
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1
Research Site
A Coruña, Spain, 15006
2
Research Site
Alicante, Spain, 03010
3
Research Site
Badajoz, Spain, 6006
4
Research Site
Badalona, Spain, 08916