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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 (CANOPY-1)

Primary Purpose

Non-small Cell Lung Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

canakinumab

canakinumab matching placebo

pembrolizumab

carboplatin

cisplatin

paclitaxel

nab-paclitaxel

pemetrexed

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring ACZ885, canakinumab, pembrolizumab, carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, NSCLC, non-small cell lung cancer, non small cell lung cancer, squamous, non-squamous, hsCRP, IL-1β, PD-L1, CANOPY, CANOPY-1, platinum-based doublet chemotherapy, first line therapy, locally advanced, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

canakinumab

canakinumab matching-placebo

Arm Description

canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy

canakinumab matching-placebo in combination with pembrolizumab and platinum-based doublet chemotherapy

Outcomes

Primary Outcome Measures

Safety run-in part: Incidence of dose limiting toxicities (DLTs)

Incidence of DLTs assessed among at least 6 evaluable subjects during the first 42 days of study treatment

Double-blind, randomized, placebo-controlled part: Progression free survival (PFS) per investigator assessment using RECIST v1.1

Progression free survival is defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1(Response evaluation criteria in solid tumor) or death due to any cause

Double-blind, randomized, placebo-controlled part: Overall survival (OS) per investigator assessment using RECIST v1.1

Overall survival is defined as the time from date of randomization to date of death due to any cause

Secondary Outcome Measures

Safety run-in part: Overall response rate (ORR) per investigator assessment using RECIST v1.1

ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1

Double-blind, randomized, placebo-controlled part : Overall response rate (ORR) per investigator assessment using RECIST v1.1

ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1

Safety run-in part: Disease control rate (DCR) per investigator assessment using RECIST v1.1

Disease control rate is defined as the proportion of patients with complete response (CR) or partial response (PR) or subjects with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria

Double-blind, randomized, placebo-controlled part : Disease control rate (DCR) per investigator assessment using RECIST v1.1

Safety run-in part: Duration of response (DOR) per investigator assessment using RECIST v1.1

Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria

Double-blind, randomized, placebo-controlled part : Duration of response (DOR) per investigator assessment using RECIST v1.1

Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria

Double-blind, randomized, placebo-controlled part only: Time to response (TTR) per investigator assessment using RECIST v1.1

Time to response (TTR) is defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria

Safety run-in part: Antidrug antibodies (ADA) of canakinumab

Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of canakinumab

Safety run-in part: Antidrug antibodies (ADA) of pembrolizumab

Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of pembrolizumab

Safety run-in part: Serum canakinumab concentration

Double-blind, randomized, placebo-controlled part : Serum canakinumab concentration

Safety run-in part: Serum pembrolizumab concentration

Double-blind, randomized, placebo-controlled part : Serum pembrolizumab concentration

Safety run-in part: Plasma pemetrexed concentration

Double-blind, randomized, placebo-controlled part : : Plasma pemetrexed concentration

Safety run-in part: Plasma cisplatin concentration

Double-blind, randomized, placebo-controlled part: Plasma cisplatin concentration

Safety run-in part: Plasma carboplatin concentration

Double-blind, randomized, placebo-controlled part: Plasma carboplatin concentration

Safety run-in part: Plasma paclitaxel concentration

Double-blind, randomized, placebo-controlled part: Plasma paclitaxel concentration

Double-blind, randomized, placebo-controlled part: Plasma nab-paclitaxel concentration

Double-blind, randomized, placebo-controlled part only :Time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea per EORTC QLQ-LC13 questionnaire

To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

Double-blind, randomized, placebo-controlled part only: Time to definitive deterioration in global health status/quality of life, shortness of breath and pain per EORTC QLQ-C30 questionnaire

To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30)

Double-blind, randomized, placebo-controlled part only: change from baseline in score as per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire

To assess the effect of canakinumab versus placebo on patient reported outcomes ((PROs) - patient's health related quality of life)

Full Information

NCT ID

NCT03631199

First Posted

August 6, 2018

Last Updated

October 2, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03631199

Brief Title

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

Acronym

CANOPY-1

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 21, 2018 (Actual)

Primary Completion Date

August 9, 2021 (Actual)

Study Completion Date

July 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

ACZ885, canakinumab, pembrolizumab, carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, NSCLC, non-small cell lung cancer, non small cell lung cancer, squamous, non-squamous, hsCRP, IL-1β, PD-L1, CANOPY, CANOPY-1, platinum-based doublet chemotherapy, first line therapy, locally advanced, metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

673 (Actual)

8. Arms, Groups, and Interventions

Arm Title

canakinumab

Arm Type

Experimental

Arm Description

canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy

Arm Title

canakinumab matching-placebo

Arm Type

Other

Arm Description

canakinumab matching-placebo in combination with pembrolizumab and platinum-based doublet chemotherapy

Intervention Type

Drug

Intervention Name(s)

canakinumab

Other Intervention Name(s)

ACZ885

Intervention Description

canakinumab every 3 weeks (squamous and non-squamous)

Intervention Type

Drug

Intervention Name(s)

canakinumab matching placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

pembrolizumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

75 mg/m2 every 3 weeks (non-squamous)

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Description

200 mg/m2 every 3 weeks (squamous)

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel

Intervention Description

100 mg/m2 every 3 weeks (squamous)

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Intervention Description

500 mg/m2 every 3 weeks (non-squamous)

Primary Outcome Measure Information:

Title

Safety run-in part: Incidence of dose limiting toxicities (DLTs)

Description

Incidence of DLTs assessed among at least 6 evaluable subjects during the first 42 days of study treatment

Time Frame

6 months from start of safety run-in part

Title

Double-blind, randomized, placebo-controlled part: Progression free survival (PFS) per investigator assessment using RECIST v1.1

Description

Time Frame

18 months from start of randomization part

Title

Double-blind, randomized, placebo-controlled part: Overall survival (OS) per investigator assessment using RECIST v1.1

Description

Overall survival is defined as the time from date of randomization to date of death due to any cause

Time Frame

38 months from start of randomization part

Secondary Outcome Measure Information:

Title

Safety run-in part: Overall response rate (ORR) per investigator assessment using RECIST v1.1

Description

ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1

Time Frame

Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 6 months

Title

Double-blind, randomized, placebo-controlled part : Overall response rate (ORR) per investigator assessment using RECIST v1.1

Description

ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1

Time Frame

Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months

Title

Safety run-in part: Disease control rate (DCR) per investigator assessment using RECIST v1.1

Description

Time Frame

Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 6 months

Title

Double-blind, randomized, placebo-controlled part : Disease control rate (DCR) per investigator assessment using RECIST v1.1

Description

Time Frame

Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months

Title

Safety run-in part: Duration of response (DOR) per investigator assessment using RECIST v1.1

Description

Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria

Time Frame

Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 6 months

Title

Double-blind, randomized, placebo-controlled part : Duration of response (DOR) per investigator assessment using RECIST v1.1

Description

Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria

Time Frame

Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months

Title

Double-blind, randomized, placebo-controlled part only: Time to response (TTR) per investigator assessment using RECIST v1.1

Description

Time to response (TTR) is defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria

Time Frame

Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months

Title

Safety run-in part: Antidrug antibodies (ADA) of canakinumab

Time Frame

Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose

Title

Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of canakinumab

Time Frame

Predose (0 h) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose

Title

Safety run-in part: Antidrug antibodies (ADA) of pembrolizumab

Time Frame

Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose

Title

Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of pembrolizumab

Time Frame

Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose

Title

Safety run-in part: Serum canakinumab concentration

Time Frame

Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)

Title

Double-blind, randomized, placebo-controlled part : Serum canakinumab concentration

Time Frame

Title

Safety run-in part: Serum pembrolizumab concentration

Time Frame

Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)

Title

Double-blind, randomized, placebo-controlled part : Serum pembrolizumab concentration

Time Frame

Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)

Title

Safety run-in part: Plasma pemetrexed concentration

Time Frame

Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)

Title

Double-blind, randomized, placebo-controlled part : : Plasma pemetrexed concentration

Time Frame

Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)

Title

Safety run-in part: Plasma cisplatin concentration

Time Frame

Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)

Title

Double-blind, randomized, placebo-controlled part: Plasma cisplatin concentration

Time Frame

Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)

Title

Safety run-in part: Plasma carboplatin concentration

Time Frame

Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)

Title

Double-blind, randomized, placebo-controlled part: Plasma carboplatin concentration

Time Frame

Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)

Title

Safety run-in part: Plasma paclitaxel concentration

Time Frame

Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)

Title

Double-blind, randomized, placebo-controlled part: Plasma paclitaxel concentration

Time Frame

Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)

Title

Double-blind, randomized, placebo-controlled part: Plasma nab-paclitaxel concentration

Time Frame

Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)

Title

Double-blind, randomized, placebo-controlled part only :Time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea per EORTC QLQ-LC13 questionnaire

Description

Time Frame

Baseline and at day 1 of every visit (with dosing or not) until end of treatment, before each tumor assessments and 2 times (7 days and 28 days) after disease progression and up to 18 months

Title

Double-blind, randomized, placebo-controlled part only: Time to definitive deterioration in global health status/quality of life, shortness of breath and pain per EORTC QLQ-C30 questionnaire

Description

Time Frame

Baseline and at day 1 of every visit (with dosing or not) until end of treatment, before each tumor assessments and 2 times (7 days and 28 days) after disease progression and up to 18 months

Title

Double-blind, randomized, placebo-controlled part only: change from baseline in score as per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire

Description

To assess the effect of canakinumab versus placebo on patient reported outcomes ((PROs) - patient's health related quality of life)

Time Frame

Baseline and at day 1 of every visit (with dosing or not) until end of treatment, before each tumor assessments and 2 times (7 days and 28 days) after disease progression and up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Pacific Shores Medical Group .

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

USC Kenneth Norris Comprehensive Cancer Center .

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Advent Health Cancer Institute

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Wooloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Novartis Investigative Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Novartis Investigative Site

City

Linz

State/Province

Oberoesterreich

ZIP/Postal Code

A 4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Barretos

State/Province

ZIP/Postal Code

14784 400

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

01246 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Novartis Investigative Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6R 3J7

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1Z6

Country

Canada

Facility Name

Novartis Investigative Site

City

Temuco

State/Province

Region De La Araucania

ZIP/Postal Code

4810469

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Novartis Investigative Site

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150081

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Novartis Investigative Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130012

Country

China

Facility Name

Novartis Investigative Site

City

XI An

State/Province

Shanxi

ZIP/Postal Code

710038

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100036

Country

China

Facility Name

Novartis Investigative Site

City

Valledupar

State/Province

Cesar

ZIP/Postal Code

5602310

Country

Colombia

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 2

State/Province

Czech Republic

ZIP/Postal Code

128 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno - Bohunice

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava Vitkovice

ZIP/Postal Code

703 84

Country

Czechia

Facility Name

Novartis Investigative Site

City

Herning

ZIP/Postal Code

7400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Oulu

ZIP/Postal Code

FIN-90220

Country

Finland

Facility Name

Novartis Investigative Site

City

Marseille cedex 20

State/Province

Bouches Du Rhone

ZIP/Postal Code

13915

Country

France

Facility Name

Novartis Investigative Site

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34070

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75231

Country

France

Facility Name

Novartis Investigative Site

City

Saint Herblain

ZIP/Postal Code

44800

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Georgsmarienhuette

ZIP/Postal Code

49124

Country

Germany

Facility Name

Novartis Investigative Site

City

Gerlingen

ZIP/Postal Code

70839

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

D-04347

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

18547

Country

Greece

Facility Name

Novartis Investigative Site

City

Kowloon

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Reykjavik

ZIP/Postal Code

IS-101

Country

Iceland

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 034

Country

India

Facility Name

Novartis Investigative Site

City

Gurgaon

State/Province

Haryana

ZIP/Postal Code

122 001

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411013

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302017

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500082

Country

India

Facility Name

Novartis Investigative Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700160

Country

India

Facility Name

Novartis Investigative Site

City

Avellino

State/Province

ZIP/Postal Code

83100

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20141

Country

Italy

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

ZIP/Postal Code

41100

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35100

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

State/Province

ZIP/Postal Code

06129

Country

Italy

Facility Name

Novartis Investigative Site

City

Parma

State/Province

ZIP/Postal Code

43100

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464 8681

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo city

State/Province

Hokkaido

ZIP/Postal Code

060 8648

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji

State/Province

Hyogo

ZIP/Postal Code

670-8520

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakai

State/Province

Osaka

ZIP/Postal Code

591-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Sunto Gun

State/Province

Shizuoka

ZIP/Postal Code

411 8777

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104 0045

Country

Japan

Facility Name

Novartis Investigative Site

City

Ube-city

State/Province

Yamaguchi

ZIP/Postal Code

755-0241

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novartis Investigative Site

City

Gyeonggi do

State/Province

Korea

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Ashrafieh

ZIP/Postal Code

166830

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Saida

ZIP/Postal Code

652

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Kuantan

State/Province

Pahang

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuching

State/Province

Sarawak

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9728 NZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Drammen

ZIP/Postal Code

3004

Country

Norway

Facility Name

Novartis Investigative Site

City

Taguig City

State/Province

Metro Manila

ZIP/Postal Code

1634

Country

Philippines

Facility Name

Novartis Investigative Site

City

Makati City

ZIP/Postal Code

1229

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Novartis Investigative Site

City

San Juan City

ZIP/Postal Code

1500

Country

Philippines

Facility Name

Novartis Investigative Site

City

Gliwice

ZIP/Postal Code

44 101

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60 569

Country

Poland

Facility Name

Novartis Investigative Site

City

Tomaszw Mazowiecki

ZIP/Postal Code

97-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1769-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200347

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

400124

Country

Romania

Facility Name

Novartis Investigative Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Pushkin Saint Petersburg

ZIP/Postal Code

196603

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

192148

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

168583

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

83310

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Partizanske

ZIP/Postal Code

958 03

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Granada

State/Province

Andalucia

ZIP/Postal Code

18014

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas De Gran Canarias

State/Province

Las Palmas De Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Songkhla

State/Province

Hat Yai

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

State/Province

THA

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34214

Country

Turkey

Facility Name

Novartis Investigative Site

City

High Heaton

State/Province

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 2BX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Learn more about this trial

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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 (CANOPY-1)

Non-small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial