Estudio internacional multicéntrico de fase III, doble ciego, controlado con placebo, de durvalumab neoadyuvante/adyuvante para el tratamiento de pacientes con cáncer de pulmón de células no pequeñas resecable en estadios II y III (AEGEAN).

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03800134Tipo: INTERVENTIONALInicio: 6 de dic de 2018Fin estimado: 11 de sept de 2028

Resumen

Estudio internacional multicéntrico de fase III, aleatorizado, doble ciego, controlado con placebo, que evalúa la actividad de durvalumab y quimioterapia administrados antes de la cirugía en comparación con placebo y quimioterapia administrados antes de la cirugía en términos de respuesta patológica completa.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 120 YearsSexo: ALL

Criterios de inclusión

Age ≥18 years
Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select \[ie, N2\] Stage IIIB) disease
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
Adequate organ and marrow function
Confirmation of a patient's tumour PD-L1 status
Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

Criterios de exclusión

History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
History of another primary malignancy
History of active primary immunodeficiency
Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
Deemed unresectable NSCLC by multidisciplinary evaluation
Patients who have pre-operative radiotherapy treatment as part of their care plan
Patients who have brain metastases or spinal cord compression
Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
Known allergy or hypersensitivity to any of the study drugs or excipients
Existence of more than one primary tumour such as mixed small cell and NSCLC histology
Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
Patients with a documented test result confirming the presence of EGFRm or ALK translocation

Intervenciones

drug

Durvalumab

1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

other

Placebo

Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

drug

Carboplatin

Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles

drug

Cisplatin

75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles

drug

Pemetrexed

500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

drug

Paclitaxel

200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

drug

Gemcitabine

1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.

procedure

Surgery

Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

CABA, Argentina

Research Site

CABA, Argentina

Research Site

La Plata, Argentina

Research Site

Pergamino, Argentina

Research Site

Rosario, Argentina

Research Site

San Salvador de Jujuy, Argentina

Research Site

Viedma, Argentina

Patrocinadores

PrincipalAstraZeneca

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