Lung Cancer Clinical Trial
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
Summary
This is 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 subjects.
The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.
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.
Other protocol-defined inclusion/exclusion criteria may apply.
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There are 149 Locations for this study
Long Beach California, 90813, United States
Los Angeles California, 90033, United States
Orlando Florida, 32804, United States
Boston Massachusetts, 02215, United States
Caba Buenos Aires, C1426, Argentina
Buenos Aires , C1431, Argentina
Westmead New South Wales, 2145, Australia
Wooloongabba Queensland, 4102, Australia
Melbourne Victoria, 3000, Australia
Murdoch Western Australia, 6150, Australia
Linz Oberoesterreich, A 402, Austria
Salzburg , 5020, Austria
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Sao Paulo SP, 04014, Brazil
Edmonton Alberta, T6G 1, Canada
Brampton Ontario, L6R 3, Canada
Toronto Ontario, M5G 1, Canada
Temuco Region De La Araucania, 48104, Chile
Santiago , 84203, Chile
Harbin Heilongjiang, 15008, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43003, China
Changsha Hunan, 41001, China
Changchun Jilin, 13001, China
Xi'an Shanxi, 71003, China
Hangzhou Zhejiang, 31002, China
Beijing , 10003, China
Valledupar Cesar, 56023, Colombia
Brno Czech Republic, 656 5, Czechia
Prague 2 Czech Republic, 128 0, Czechia
Brno - Bohunice , 625 0, Czechia
Ostrava Vitkovice , 703 8, Czechia
Herning , 7400, Denmark
Oulu , FIN-9, Finland
Marseille cedex 20 Bouches Du Rhone, 13915, France
Lyon Cedex , 69373, France
Montpellier , 34070, France
Paris , 75231, France
Saint Herblain , 44800, France
Berlin , 13125, Germany
Dresden , 01307, Germany
Essen , 45147, Germany
Georgsmarienhuette , 49124, Germany
Gerlingen , 70839, Germany
Gottingen , 37075, Germany
Halle (Saale) , 06120, Germany
Heidelberg , 69120, Germany
Koeln , 50937, Germany
Koeln , 51109, Germany
Leipzig , D-043, Germany
Muenchen , 81377, Germany
Athens GR, 115 2, Greece
Athens , 18547, Greece
Kowloon , , Hong Kong
Veszprem , 8200, Hungary
Reykjavik , IS-10, Iceland
Hyderabad Andhra Pradesh, 500 0, India
Gurgaon Haryana, 122 0, India
Pune Maharashtra, 41101, India
Jaipur Rajasthan, 30201, India
Hyderabad Telangana, 50008, India
Kolkata West Bengal, 70016, India
Avellino AV, 83100, Italy
Genova GE, 16132, Italy
Milano MI, 20132, Italy
Milano MI, 20133, Italy
Milano MI, 20141, Italy
Rozzano MI, 20089, Italy
Modena MO, 41100, Italy
Padova PD, 35100, Italy
Perugia PG, 06129, Italy
Parma PR, 43100, Italy
Orbassano TO, 10043, Italy
Nagoya Aichi, 464 8, Japan
Sapporo city Hokkaido, 060 8, Japan
Himeji Hyogo, 670-8, Japan
Yokohama-city Kanagawa, 241-8, Japan
Sakai Osaka, 591-8, Japan
Sunto Gun Shizuoka, 411 8, Japan
Chuo ku Tokyo, 104 0, Japan
Ube-city Yamaguchi, 755-0, Japan
Osaka , 545-8, Japan
Gyeonggi do Korea, 10408, Korea, Republic of
Seoul Seocho Gu, 06591, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Ashrafieh , 16683, Lebanon
Saida , 652, Lebanon
Kuantan Pahang, 25100, Malaysia
Kuching Sarawak, 93586, Malaysia
Kuala Lumpur Wilayah Persekutuan, 50586, Malaysia
Kuala Lumpur , 59100, Malaysia
Groningen , 9713 , Netherlands
Groningen , 9728 , Netherlands
Drammen , 3004, Norway
Taguig City Metro Manila, 1634, Philippines
Makati City , 1229, Philippines
Quezon City , 1102, Philippines
San Juan City , 1500, Philippines
Gliwice , 44 10, Poland
Poznan , 60 56, Poland
Tomaszw Mazowiecki , 97-20, Poland
Lisboa , 1769-, Portugal
Porto , 4200-, Portugal
Craiova Dolj, 20034, Romania
Cluj-Napoca , 40012, Romania
Arkhangelsk , 16304, Russian Federation
Omsk , 64401, Russian Federation
Pushkin Saint Petersburg , 19660, Russian Federation
Saint Petersburg , 19702, Russian Federation
St Petersburg , 19214, Russian Federation
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Singapore , 30843, Singapore
Bratislava , 83310, Slovakia
Partizanske , , Slovakia
Granada Andalucia, 18014, Spain
Malaga Andalucia, 29010, Spain
Badalona Catalunya, 08916, Spain
Barcelona Catalunya, 08035, Spain
Barcelona Catalunya, 08036, Spain
Valencia Comunidad Valenciana, 46026, Spain
Las Palmas De Gran Canarias Las Palmas De Gran Canaria, 35016, Spain
San Sebastian Pais Vasco, 20080, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Zaragoza , 50009, Spain
Stockholm , 171 7, Sweden
Basel , 4031, Switzerland
Kaohsiung City , 83301, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
Songkhla Hat Yai, 90110, Thailand
Khon Kaen THA, 40002, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Ankara , 06100, Turkey
Edirne , 22030, Turkey
Istanbul , 34214, Turkey
High Heaton Newcastle Upon Tyne, NE7 7, United Kingdom
London , NW3 2, United Kingdom
Manchester , M20 2, United Kingdom
Plymouth , PL6 8, United Kingdom
Hanoi , 10000, Vietnam
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