A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT03735121Tipo: INTERVENTIONALInicio: 27 de dic de 2018Fin estimado: 11 de nov de 2024

Traducción no disponible, mostrando original

Resumen

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Measurable disease as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy ≥12 weeks
Histologically or cytologically documented locally advanced or metastatic NSCLC
Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen.
Adequate hematologic and end-organ function

Criterios de exclusión

Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Uncontrolled or symptomatic hypercalcemia
Pregnancy or breastfeeding
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
Severe infection ≤ 4 weeks
Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment
Significant cardiovascular disease
Prior allogeneic stem cell or solid organ transplantation
Treatment with a live, attenuated vaccine ≤ 4 weeks
Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug
Treatment with systemic immunosuppressive medication ≤ 2 weeks
• Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive

Intervenciones

drug

Atezolizumab

Atezolizumab will be administered as per the schedule specified in arm or cohort.

drug

rHuPH20

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Ubicaciones

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Consultorio Dr. Miguel Angel Escudero

Salta, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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.

A Randomized, Multicenter, Phase Ib/III Study to Investig... | EligiMed