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Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

NCT03631199

TerminatedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Non-small Cell Lung Cancer

Interventions: canakinumab, canakinumab-matching placebo, pembrolizumab, carboplatin, cisplatin

Countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key inclusion criteria:

* 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.
* Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
* At least 1 measurable lesion by RECIST 1.1

Key exclusion criteria:

* 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.
Locations (152)
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Orlando, Florida, United States
  • Boston, Massachusetts, United States
  • Caba, Buenos Aires, Argentina
  • Caba, Argentina
  • Westmead, New South Wales, Australia
  • Wooloongabba, Queensland, Australia
  • Melbourne, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Linz, Upper Austria, Austria
  • Salzburg, Austria
  • Barretos, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Edmonton, Alberta, Canada
  • Brampton, Ontario, Canada
  • Toronto, Ontario, Canada
  • Temuco, Araucania, Chile
  • Santiago, Chile
  • Harbin, Heilongjiang, China
  • Wuhan, Hubei, China
  • Wuhan, Hubei, China
  • Changsha, Hunan, China
  • Changchun, Jilin, China
  • Xi’an, Shanxi, China
  • Hangzhou, Zhejiang, China
  • Beijing, China
  • Valledupar, Cesar Department, Colombia
  • Ostrava, Vitkovice, Czechia
  • + 122 more on CT.gov