A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

TerminadoFase 3ClinicalTrials.gov

ID: NCT03631199Tipo: INTERVENTIONALInicio: 21 de dic de 2018Fin estimado: 26 de ene de 2026

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Resumen

This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.

Descripción detallada

The study primarily assessed the safety and tolerability (safety run-in Part A) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab, and then, the efficacy (double-blind, randomized, placebo-controlled Part B) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.
At least 1 measurable lesion by RECIST 1.1

Criterios de exclusión

Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing.
Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.
Subject with suspected or proven immune-compromised state or infections.
Subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.

Intervenciones

drug

canakinumab

canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)

drug

canakinumab-matching placebo

canakinumab placebo every 3 weeks (squamous and non-squamous)

drug

pembrolizumab

200 mg every 3 weeks (squamous and non-squamous)

drug

carboplatin

Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)

drug

cisplatin

75 mg/m\^2 every 3 weeks (non-squamous)

drug

paclitaxel

200 mg/m\^2 every 3 weeks (squamous)

drug

nab-paclitaxel

100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)

drug

pemetrexed

500 mg/m\^2 every 3 weeks (non-squamous)

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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