Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT04712903
Last Updated: 2025-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2020-12-16
2023-06-21
Brief Summary
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Detailed Description
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Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Durvalumab in Combination with Platinum-Etoposide
Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
Durvalumab
Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
Cisplatin
Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.
Etoposide
Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.
Carboplatin
Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.
Interventions
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Durvalumab
Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
Cisplatin
Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.
Etoposide
Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.
Carboplatin
Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Dolores Isla, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Lozano Blesa, Zaragoza
Locations
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Research Site
A Coruña, , Spain
Research Site
Alicante, , Spain
Research Site
Badajoz, , Spain
Research Site
Badalona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Castellon, , Spain
Research Site
Córdoba, , Spain
Research Site
Galdakao, , Spain
Research Site
Granada, , Spain
Research Site
Jaén, , Spain
Research Site
León, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Majadahonda, , Spain
Research Site
Mataró, , Spain
Research Site
Málaga, , Spain
Research Site
Murcia, , Spain
Research Site
Ourense, , Spain
Research Site
Oviedo, , Spain
Research Site
Palma, , Spain
Research Site
Reus,Tarragona, , Spain
Research Site
San Cristóbal de La Laguna, , Spain
Research Site
San Sebastián, , Spain
Research Site
Santander, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Toledo, , Spain
Research Site
Valencia, , Spain
Research Site
Valladolid, , Spain
Research Site
Zaragoza, , Spain
Countries
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References
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Isla D, Zugazagoitia J, Arriola E, Garcia-Campelo R, Marti Blanco C, Diz-Tain MP, Lopez-Brea M, Moreno-Vega AL, Leon-Mateos L, Oramas J, Gutierrez-Calderon V, Majem M, Sanchez-Hernandez A, Aguado C, Alvarez-Cabellos R, Massuti B, Moreno A, Firvida-Perez JL, Valdivia J, Gonzalez-Cordero M, Zafra-Poves M, Domine M, Garcia-Navalon FJ, Villanueva N, Provencio M, Juan-Vidal O, Rivas-Corredor C, Olmedo Garcia ME, Palmero R, Lopez-Castro R, Carcereny E, Lechuga JL, Dominguez M, Callejo A, Paz-Ares L. Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial. Lung Cancer. 2025 Sep 24;209:108763. doi: 10.1016/j.lungcan.2025.108763. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2020-002328-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D419QC00005
Identifier Type: -
Identifier Source: org_study_id
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