A Multicenter, Randomized, Double-blind Phase III Trial to Evaluate Efficacy and Safety of BI 695502 Plus Chemotherapy Versus Avastin® Plus Chemotherapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT02272413Tipo: INTERVENTIONALInicio: 8 de jul de 2015Fin estimado: 16 de nov de 2018

Traducción no disponible, mostrando original

Resumen

The objective of this phase III trial is to establish statistical equivalence in terms of efficacy (best overall response rate \[ORR\], proportion of patients with complete response \[CR\] plus partial response \[PR\]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult patients aged \>=18 years with histologically or cytologically confirmed advanced nonsquamous non-small cell lung cancer (nsNSCLC). Mixed tumors should be categorized according to the predominant histology.
Note: NSCLC should be predominantly nonsquamous. Recurrent or metastatic disease (Stage IV) with an indication for therapy with paclitaxel + carboplatin + Avastin®.
Patients harboring tumors with unknown or without activating epidermal growth factor receptor (EGFR) / anaplastic lymphoma receptor tyrosine kinase (ALK) mutation maybe included provided chemotherapy is standard of care. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independent central review.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Adequate hepatic, renal, and bone marrow function:

Criterios de exclusión

Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.
Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or radiotherapy for locally advanced nsNSCLC if completed \<12 months prior to Screening.
Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix.
Symptomatic brain metastasis. Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung, NSCLC not specified (NS) or NSCLC not otherwise specified(NOS).
Any unresolved toxicity \> Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy).

Intervenciones

drug

BI 695502

drug

Avastin

Ubicaciones

CENIT - Centro de Neurociencias, Investigacion y Tratamiento

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Delta

Rosario, Argentina

Sanatorio Parque

Rosario, Argentina

Centro Oncológico de Rosario

Rosario, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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