A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03703297RENIS: IS002406Tipo: INTERVENTIONALInicio: 27 de sept de 2018Fin estimado: 23 de oct de 2026

Traducción no disponible, mostrando original

Resumen

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.
Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.

Criterios de exclusión

Extensive-stage SCLC
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Active infection including tuberculosis, HIV, hepatitis B and C
Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

Intervenciones

drug

Durvalumab

Durvalumab IV (intravenous infusion)

drug

Tremelimumab

Tremelimumab IV (intravenous infusion)

other

Placebo

Placebo IV (intravenous infusion)

Ubicaciones

Research Site

CABA, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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