Resumen

El objetivo principal de este estudio fue demostrar la superioridad de avelumab versus docetaxel en cuanto a supervivencia global en participantes con cáncer de pulmón de células no pequeñas (CPCNP) positivo para el ligando de muerte programada 1 (PD-L1) tras el fracaso de un doblete basado en platino.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed written informed consent before any trial related procedure
Male or female participants aged greater than or equal to (\>=) 18 years
Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression
Participants must have progressed after an acceptable therapy defined as follows:
Participants must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR
Participants must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
Estimated life expectancy of more than 12 weeks
Adequate hematological function defined by White Blood Cell (WBC) count \>= 2.5 × 10\^9/L with absolute neutrophil count (ANC) \>= 1.5 × 10\^9/L, lymphocyte count \>=0.5 × 10\^9/L, platelet count \>= 100 × 10\^9/L, and hemoglobin \>= 9 gram per deciliter (g/dL) (may have been transfused)
Adequate hepatic function defined by a total bilirubin level less than or equal to (\<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \<= 2.5 × ULN for all participants
Adequate renal function defined by an estimated creatinine clearance \> 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method).

Criterios de exclusión

In the United States only, participants with a squamous cell histology will be excluded
Systemic anticancer therapy administered after disease progression during or following a platinum based combination
Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Participants of unknown ALK and/or EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available)
Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
Concurrent anticancer treatment
Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the participant has not fully recovered from the surgery within 4 weeks of randomization
Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.
All participants with brain metastases, except those meeting the following criteria:
Brain metastases have been treated locally, and
No ongoing neurological symptoms that are related to the brain localization of the disease
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
Participants with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses less than or equal to (\<=)10 milligram (mg) or equivalent prednisone per day
Administration of steroids through a route known to result in a minimal systemic exposure are acceptable
Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be \<=10 mg per day of equivalent prednisone

Intervenciones

drug

Avelumab

Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

drug

Docetaxel

Participants received 75 mg per square meter (m\^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

Ubicaciones

Hospital Italiano Regional del Sur

Bahía Blanca, Argentina

Clínica Universitaria Privada Reina Fabiola

Barrio General Paz, Argentina

Centro de Oncologia e Investigacion Buenos Aires

Berazategui, Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma Buenos Aires, Argentina

CEMIC

Ciudad Autonoma Buenos Aires, Argentina

Instituto DAMIC Fundacion Rusculleda

Córdoba, Argentina

Centro Oncologico Riojano Integral (Cori)

La Rioja, Argentina

Centro Oncologico de Parana

Paraná, Argentina

Hospital Universitario Austral

Pilar, Argentina

Instituto Gamma

Rosario, Argentina

Sanatorio Parque S.A.

Rosario, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Centro Medico San Roque S.R.L.

San Miguel de Tucumán, Argentina

Un Ensayo Abierto, Multicéntrico de Fase III de avelumab (MSB0010718C) versus docetaxel en Sujetos con Cáncer de Pulmón de Células no Pequeñas que ha Progresado tras un Doblete que Contiene Platino

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Avelumab

Docetaxel

Ubicaciones

Hospital Italiano Regional del Sur

Clínica Universitaria Privada Reina Fabiola

Centro de Oncologia e Investigacion Buenos Aires

Instituto Medico Especializado Alexander Fleming

CEMIC

Instituto DAMIC Fundacion Rusculleda

Centro Oncologico Riojano Integral (Cori)

Centro Oncologico de Parana

Hospital Universitario Austral

Instituto Gamma

Sanatorio Parque S.A.

Instituto de Oncología de Rosario

Centro Medico San Roque S.R.L.

Patrocinadores