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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

NCT ID: NCT03631199

Last Updated: 2025-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

673 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2027-06-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: Cohort A

Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.

Group Type EXPERIMENTAL

canakinumab

Intervention Type DRUG

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

pembrolizumab

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

pemetrexed

Intervention Type DRUG

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

Part 1: Cohort B

Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.

Group Type EXPERIMENTAL

canakinumab

Intervention Type DRUG

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

pembrolizumab

Intervention Type DRUG

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

cisplatin

Intervention Type DRUG

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

pemetrexed

Intervention Type DRUG

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

Part 1: Cohort C

Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.

Group Type EXPERIMENTAL

canakinumab

Intervention Type DRUG

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

pembrolizumab

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

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

Part 2: Canakinumab+pembro+CTx

Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.

Group Type EXPERIMENTAL

canakinumab

Intervention Type DRUG

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

pembrolizumab

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

cisplatin

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

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

nab-paclitaxel

Intervention Type DRUG

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

pemetrexed

Intervention Type DRUG

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

Part 2: Placebo+pembro+CTx

Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.

Group Type OTHER

canakinumab-matching placebo

Intervention Type DRUG

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

pembrolizumab

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

cisplatin

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

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

nab-paclitaxel

Intervention Type DRUG

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

pemetrexed

Intervention Type DRUG

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

Interventions

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canakinumab

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

Intervention Type DRUG

canakinumab-matching placebo

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

Intervention Type DRUG

pembrolizumab

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

Intervention Type DRUG

carboplatin

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

Intervention Type DRUG

cisplatin

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

Intervention Type DRUG

paclitaxel

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

Intervention Type DRUG

nab-paclitaxel

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

Intervention Type DRUG

pemetrexed

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

Intervention Type DRUG

Other Intervention Names

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ACZ885

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Pacific Shores Medical Group

Long Beach, California, United States

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USC Kenneth Norris Comprehensive Cancer Center

Los Angeles, California, United States

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Advent Health Cancer Institute

Orlando, Florida, United States

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

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Novartis Investigative Site

CABA, Buenos Aires, Argentina

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Caba, , Argentina

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Westmead, New South Wales, Australia

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Wooloongabba, Queensland, Australia

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Melbourne, Victoria, Australia

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Murdoch, Western Australia, Australia

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Linz, Upper Austria, Austria

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Salzburg, , Austria

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Barretos, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Brampton, Ontario, Canada

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Toronto, Ontario, Canada

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Temuco, Región de la Araucanía, Chile

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Santiago, , Chile

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Harbin, Heilongjiang, China

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Wuhan, Hubei, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Changchun, Jilin, China

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Xi’an, Shanxi, China

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Hangzhou, Zhejiang, China

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Beijing, , China

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Valledupar, Cesar Department, Colombia

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Ostrava, Vitkovice, Czechia

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Brno, , Czechia

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Brno, , Czechia

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Prague, , Czechia

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Herning, , Denmark

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Oulu, , Finland

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Marseille, Bouches Du Rhone, France

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Lyon, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

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Munich, Bavaria, Germany

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Göttingen, Lower Saxony, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Cologne, , Germany

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Essen, , Germany

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Georgsmarienhütte, , Germany

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Gerlingen, , Germany

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Heidelberg, , Germany

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Athens, GR, Greece

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Athens, , Greece

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Kowloon, , Hong Kong

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Veszprém, , Hungary

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Reykjavik, , Iceland

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Hyderabad, Andhra Pradesh, India

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Gurgaon, Haryana, India

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Pune, Maharashtra, India

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Jaipur, Rajasthan, India

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Hyderabad, Telangana, India

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Kolkata, West Bengal, India

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Avellino, AV, Italy

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Genova, GE, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Modena, MO, Italy

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Padua, PD, Italy

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Perugia, PG, Italy

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Parma, PR, Italy

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Orbassano, TO, Italy

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Nagoya, Aichi-ken, Japan

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Sapporo, Hokkaido, Japan

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Himeji, Hyōgo, Japan

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Yokohama, Kanagawa, Japan

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Sakai, Osaka, Japan

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Sunto Gun, Shizuoka, Japan

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Chuo Ku, Tokyo, Japan

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Ube, Yamaguchi, Japan

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Osaka, , Japan

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Beirut, , Lebanon

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Saida, , Lebanon

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Kuala Lumpur, Kuala Lumpur, Malaysia

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Kuantan, Pahang, Malaysia

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Kuching, Sarawak, Malaysia

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Kuala Lumpur, , Malaysia

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Groningen, , Netherlands

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Groningen, , Netherlands

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Drammen, , Norway

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City of Taguig, National Capital Region, Philippines

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Makati City, , Philippines

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Quezon, , Philippines

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San Juan City, , Philippines

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Gliwice, , Poland

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Poznan, , Poland

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Tomaszw Mazowiecki, , Poland

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Lisbon, , Portugal

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Porto, , Portugal

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Craiova, Dolj, Romania

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Cluj-Napoca, , Romania

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Arkhangelsk, , Russia

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Omsk, , Russia

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Pushkin Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Bratislava, , Slovakia

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Partizánske, , Slovakia

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Gyeonggi-do, Korea, South Korea

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Seoul, Seocho Gu, South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Granada, Andalusia, Spain

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Donostia / San Sebastian, Basque Country, Spain

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Badalona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, , Spain

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Las Palmas de Gran Canaria, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Stockholm, , Sweden

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Basel, , Switzerland

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Kaohsiung City, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Songkhla, Hat Yai, Thailand

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Khon Kaen, THA, Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Istanbul, Bagcilar, Turkey (Türkiye)

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Ankara, Bilkent-Cankaya, Turkey (Türkiye)

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Edirne, Merkez, Turkey (Türkiye)

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Ankara, Sihhiye-Altindag, Turkey (Türkiye)

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High Heaton, Newcastle Upon Tyne, United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Plymouth, , United Kingdom

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Hanoi, , Vietnam

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Countries

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United States Argentina Australia Austria Brazil Canada Chile China Colombia Czechia Denmark Finland France Germany Greece Hong Kong Hungary Iceland India Italy Japan Lebanon Malaysia Netherlands Norway Philippines Poland Portugal Romania Russia Singapore Slovakia South Korea Spain Sweden Switzerland Taiwan Thailand Turkey (Türkiye) United Kingdom Vietnam

References

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Tan DSW, Felip E, de Castro G, Solomon BJ, Greystoke A, Cho BC, Cobo M, Kim TM, Ganguly S, Carcereny E, Paz-Ares L, Bennouna J, Garassino MC, Schenker M, Kim SW, Brase JC, Bury-Maynard D, Passos VQ, Deudon S, Dharan B, Song Y, Caparica R, Johnson BE. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. J Clin Oncol. 2024 Jan 10;42(2):192-204. doi: 10.1200/JCO.23.00980. Epub 2023 Dec 1.

Reference Type DERIVED
PMID: 38039427 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2024-511490-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CACZ885U2301

Identifier Type: -

Identifier Source: org_study_id

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Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)
NCT02142738 COMPLETED PHASE3