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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03626545

Registration number

NCT03626545

Ethics application status

Date submitted

25/07/2018

Date registered

13/08/2018

Titles & IDs

Public title

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

Scientific title

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)

Secondary ID [1]

2018-002480-26

Secondary ID [2]

CACZ885V2301

Universal Trial Number (UTN)

Trial acronym

CANOPY-2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Non-Small-Cell Lung

Condition category

Condition code

Cancer

Lung - Mesothelioma

Cancer

Lung - Non small cell

Cancer

Lung - Small cell

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Canakinumab
Treatment: Drugs - Docetaxel
Other interventions - Placebo

Experimental: Safety run-in part: Canakinumab+docetaxel - Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1). Subjects were assessed for at least 2 complete cycles of treatment (21 days per cycle; a total of 42 days) for safety evaluation (DLT) to define RP3R. De-escalation to canakinumab 200 mg subcutaneous every 6 weeks + docetaxel 75 mg/m\^2, every 3 weeks could also be considered.

Experimental: Randomized part: Canakinumab + docetaxel - Participants were treated with canakinumab subcutaneous at RP3R and docetaxel at 75 mg/m\^2 every 3 weeks

Placebo comparator: Randomized part: Placebo + docetaxel - Participants were treated with placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 every 3 weeks

Treatment: Drugs: Canakinumab
Canakinumab, 200 mg, subcutaneous. The initial dose regimen was once every 3 weeks (on Day 1 of each 21-day cycle)

Treatment: Drugs: Docetaxel
Docetaxel 75mg/m\^2, intravenous, administered on Day 1 of each 21-day cycle

Other interventions: Placebo
Placebo, sub-cutaneous, admnistered at the RP3R defined in Part 1-safety run-in.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs)

Assessment method [1]

Percentage of participants with DLTs. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 42 days of docetaxel and canakinumab treatment.

Timepoint [1]

During the first 42 days of dosing

Primary outcome [2]

Randomized Part: Overall Survival (OS)

Assessment method [2]

OS is defined as the time from randomization to date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. If a subject was not known to have died, then OS was censored at the latest date the subject was known to be alive (on or before the cut-off date).

Timepoint [2]

From randomization until death or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approximately (approx.) 18 months)

Secondary outcome [1]

Overall Response Rate (ORR)

Assessment method [1]

ORR is defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Timepoint [1]

Through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 10 months for the safety run-in part and 18 months for the randomized part)

Secondary outcome [2]

Duration of Response (DOR)

Assessment method [2]

DOR is defined as the time from first documented response of CR or PR to date of first documented progression or death, by investigator's assessment according to RECIST 1.1 criteria. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Timepoint [2]

From first documented response of CR or PR to date of first documented progression, death or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approx. 10 months for the safety run-in and 18 months for the randomized)

Secondary outcome [3]

Disease Control Rate (DCR)

Assessment method [3]

DCR is defined as the percentage of participants with CR or PR or with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. The 95% CIs were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Timepoint [3]

Through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 10 months for the safety run-in part and 18 months for the randomized part)

Secondary outcome [4]

Randomized Part: Progression-Free Survival (PFS)

Assessment method [4]

PFS is defined as the time from randomization to the date of the first documented radiological progression by investigator assessment according to RECIST 1.1 response criteria or death due to any cause. The PFS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. If a participant did not have disease progression or die at the analysis cut-off date, PFS was censored at the date of last adequate tumor assessment.

Timepoint [4]

From randomization until disease progression, death or final analysis data cutoff date (08-Jan-2021) whichever comes first (assessed up to approx. 18 months)

Secondary outcome [5]

Randomized Part: Time to Response (TTR)

Assessment method [5]

TTR is defined as the time from the date of randomization to the date of first documented response of either CR or PR, by investigator's assessment according to RECIST 1.1 criteria. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. Subjects without a confirmed CR or PR at the time of the analysis cut-off date were censored at the study-maximum follow-up time for subjects with a PFS event (i.e., disease progression or death due to any cause), or at the date of the last adequate tumor assessment for subjects without a PFS event. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Timepoint [5]

From randomization until first documented response or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approx. 18 months)

Secondary outcome [6]

Randomized Part: Time to Definitive 10-point Deterioration (TTD) Symptom Scores of Chest Pain, Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Lung Cancer (LC13) Questionnaire

Assessment method [6]

The EORTC QLQ-LC13 comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain) and treatment-related symptoms from conventional chemotherapy and radiotherapy (ie. hair loss, neuropathy, sore mouth, and dysphagia). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTD for chest pain, cough and dyspnea is defined as the time from randomization to the date of event, which is defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.\<10 points was observed or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurs earlier). If a subject did not have an event, TTD was censored at the last adequate assessment.

Timepoint [6]

From baseline through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 18 months)

Secondary outcome [7]

Randomized Part: Time to Definitive 10-point Deterioration in Global Health Status (GHS)/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire

Assessment method [7]

The EORTC QLQ-C30 includes 5 functional scales (physical,role,cognitive,emotional and social), 3 symptom scales (fatigue,pain and nausea/vomiting), a GHS/QoL scale, and 6 single items (constipation,diarrhea,insomnia,shortness of breath,appetite loss and financial difficulties). For each scale and single-item, scores range between 0 and 100. A high score for functional scales/ GHS/QoL represents better functioning or QoL, a high score for symptom scales/single items represents significant symptomatology. TTD in GHS/QoL, shortness of breath and pain is defined as the time from randomization to the date of event, defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold i.e.\<10 points was observed or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurs earlier). If a subject did not have an event, TTD was censored at the last adequate assessment.

Timepoint [7]

From baseline through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 18 months)

Secondary outcome [8]

Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire

Assessment method [8]

The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and 6 single items (constipation, diarrhea, insomnia, dyspnoea, appetite loss and financial difficulties). For each scale and item, scores range 0-100. A high score for functional scales/QoL represents better functioning/QoL; a high score for symptom scales and items represents significant symptomatology. Changes from baseline in QoL, shortness of breath and pain scores are presented. For QoL, a negative change from baseline indicates improvement; for shortness of breath and pain a positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits 1, 2, 3 and 5 were conducted every 6 weeks (for the first 12 months since start of treatment) and every 12 weeks (after 12 months since start of treatment) until disease progression

Timepoint [8]

Baseline, every 3 weeks from Week 3 until end of treatment, every 6 or 12 weeks post-treatment until progression (post-treatment efficacy visits), 7 and 28 days post progression through final analysis cutoff date of 08Jan2021 (up to approx. 18 months)

Secondary outcome [9]

Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire

Assessment method [9]

The EORTC QLQ-LC13 is a 13-item questionnaire. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain) and treatment-related symptoms from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher ("worse") level of symptoms. Changes from baseline in chest pain, cough and dyspnea scores are presented. A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits 1, 2, 3 and 5 were conducted every 6 weeks (for the first 12 months since start of treatment) and every 12 weeks (after 12 months since start of treatment) until disease progression

Timepoint [9]

Secondary outcome [10]

Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores

Assessment method [10]

The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of these dimensions, the participant self-assigned a score: from 1 (no problems) to 5 (extreme problems). The 5 digit health states obtained for each dimension was converted into a single mean index value based on the EQ-5D crosswalk value set for the UK using the time trade-off method. This index ranges from -0.594 (worst health) to 1.0 (best health). A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits 1, 2, 3 and 5 were conducted every 6 weeks (for the first 12 months since start of treatment) and every 12 weeks (after 12 months since start of treatment) until disease progression

Timepoint [10]

Secondary outcome [11]

Safety run-in Part: Maximum Plasma Concentration (Cmax) of Canakinumab

Assessment method [11]

Venous whole blood samples were collected for pharmacokinetics characterization. Cmax of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Timepoint [11]

Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days

Secondary outcome [12]

Safety run-in Part: Time of Maximum Plasma Concentration (Tmax) of Canakinumab

Assessment method [12]

Venous whole blood samples were collected for pharmacokinetics characterization. Tmax of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. Actual recorded sampling times were considered for the calculations.

Timepoint [12]

Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days

Secondary outcome [13]

Safety run-in Part: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Canakinumab

Assessment method [13]

Venous whole blood samples were collected for pharmacokinetics characterization. AUClast of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Timepoint [13]

Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days

Secondary outcome [14]

Safety run-in Part: Cmax of Docetaxel

Assessment method [14]

Venous whole blood samples were collected for pharmacokinetics characterization. Cmax of docetaxel was calculated from docetaxel plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Timepoint [14]

Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days

Secondary outcome [15]

Safety run-in Part: Tmax of Docetaxel

Assessment method [15]

Venous whole blood samples were collected for pharmacokinetics characterization. Tmax of docetaxel was calculated from docetaxel plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. Actual recorded sampling times were considered for the calculations.

Timepoint [15]

Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days

Secondary outcome [16]

Safety run-in Part: AUClast of Docetaxel

Assessment method [16]

Venous whole blood samples were collected for pharmacokinetics characterization. AUClast of docetaxel was calculated from docetaxel plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Timepoint [16]

Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days

Secondary outcome [17]

Randomized Part: Pre-dose Plasma Trough Concentration (CTrough) of Canakinumab

Assessment method [17]

Venous whole blood samples were collected for pharmacokinetics characterization. CTrough of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Timepoint [17]

Pre-dose on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1 and Cycle 18 Day 1. Each cycle is 21 days.

Secondary outcome [18]

Randomized Part: Cmax of Docetaxel

Assessment method [18]

Timepoint [18]

Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days

Secondary outcome [19]

Randomized Part: Tmax of Docetaxel

Assessment method [19]

Timepoint [19]

Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days

Secondary outcome [20]

Randomized Part: AUClast of Docetaxel

Assessment method [20]

Timepoint [20]

Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days

Secondary outcome [21]

Randomized Part: Canakinumab Antidrug Antibodies (ADA) at Baseline

Assessment method [21]

ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline

Timepoint [21]

Baseline

Secondary outcome [22]

Randomized Part: Canakinumab ADA Incidence On-treatment

Assessment method [22]

ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

Timepoint [22]

Pre-dose at Cycle 1 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1 , end of treatment, and 130 days after end of treatment through final analysis data cutoff date of 08-Jan-2021 (assessed up to 18 months). Each cycle is 21 days

Eligibility

Key inclusion criteria

Key

* Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
* Subject had received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
* Subject with ECOG performance status (PS) of 0 or 1.
* Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria.

Key

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Subject who previously received docetaxel, canakinumab (or another IL-1ß inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
* Subject with EGFRor ALK positive tumor.
* History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

23/01/2019

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

20/12/2021

Sample size

Target

Accrual to date

Final

245

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Recruitment hospital [1]

Novartis Investigative Site - Greenslopes

Recruitment hospital [2]

Novartis Investigative Site - Shepparton

Recruitment postcode(s) [1]

4120 - Greenslopes

Recruitment postcode(s) [2]

3630 - Shepparton

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Georgia

Country [2]

United States of America

State/province [2]

Missouri

Country [3]

United States of America

State/province [3]

New York

Country [4]

United States of America

State/province [4]

Ohio

Country [5]

United States of America

State/province [5]

Texas

Country [6]

United States of America

State/province [6]

Utah

Country [7]

Argentina

State/province [7]

Buenos Aires

Country [8]

Argentina

State/province [8]

La Rioja

Country [9]

Argentina

State/province [9]

Santiago del Estero

Country [10]

Belgium

State/province [10]

Oost Vlaanderen

Country [11]

Belgium

State/province [11]

Bruxelles

Country [12]

Belgium

State/province [12]

Charleroi

Country [13]

Belgium

State/province [13]

Gent

Country [14]

Belgium

State/province [14]

Roeselare

Country [15]

Brazil

State/province [15]

Country [16]

Brazil

State/province [16]

Country [17]

Brazil

State/province [17]

Country [18]

Canada

State/province [18]

British Columbia

Country [19]

Canada

State/province [19]

Quebec

Country [20]

Chile

State/province [20]

Santiago

Country [21]

China

State/province [21]

Sichuan

Country [22]

China

State/province [22]

Shanghai

Country [23]

Czechia

State/province [23]

Brno - Bohunice

Country [24]

Czechia

State/province [24]

Ostrava Vitkovice

Country [25]

Denmark

State/province [25]

Herlev

Country [26]

Denmark

State/province [26]

Odense C

Country [27]

France

State/province [27]

Cedex 09

Country [28]

France

State/province [28]

Besancon Cedex

Country [29]

France

State/province [29]

Bordeaux Cedex

Country [30]

France

State/province [30]

Bron

Country [31]

France

State/province [31]

Strasbourg Cedex

Country [32]

Germany

State/province [32]

Berlin

Country [33]

Germany

State/province [33]

Dresden

Country [34]

Germany

State/province [34]

Frankfurt

Country [35]

Germany

State/province [35]

Gerlingen

Country [36]

Germany

State/province [36]

Grosshansdorf

Country [37]

Germany

State/province [37]

Koeln

Country [38]

Germany

State/province [38]

Ulm

Country [39]

Greece

State/province [39]

Heraklion Crete

Country [40]

Greece

State/province [40]

Thessaloniki

Country [41]

Hungary

State/province [41]

Pest

Country [42]

Israel

State/province [42]

Ramat Gan

Country [43]

Italy

State/province [43]

Country [44]

Italy

State/province [44]

Country [45]

Italy

State/province [45]

Country [46]

Japan

State/province [46]

Aichi

Country [47]

Japan

State/province [47]

Hyogo

Country [48]

Japan

State/province [48]

Kanagawa

Country [49]

Japan

State/province [49]

Tokyo

Country [50]

Japan

State/province [50]

Osaka

Country [51]

Jordan

State/province [51]

Amman

Country [52]

Korea, Republic of

State/province [52]

Seocho Gu

Country [53]

Korea, Republic of

State/province [53]

Seoul

Country [54]

Lebanon

State/province [54]

Ashrafieh

Country [55]

Netherlands

State/province [55]

Amsterdam

Country [56]

Netherlands

State/province [56]

Groningen

Country [57]

Netherlands

State/province [57]

Maastricht

Country [58]

Poland

State/province [58]

Gdansk

Country [59]

Poland

State/province [59]

Rzeszow

Country [60]

Poland

State/province [60]

Warszawa

Country [61]

Russian Federation

State/province [61]

Pushkin Saint Petersburg

Country [62]

Russian Federation

State/province [62]

St Petersburg

Country [63]

Singapore

State/province [63]

Singapore

Country [64]

Spain

State/province [64]

Andalucia

Country [65]

Spain

State/province [65]

Catalunya

Country [66]

Spain

State/province [66]

Comunidad Valenciana

Country [67]

Spain

State/province [67]

Galicia

Country [68]

Spain

State/province [68]

Madrid

Country [69]

Taiwan

State/province [69]

Tainan

Country [70]

Taiwan

State/province [70]

Taipei

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Novartis Pharmaceuticals

Country

Ethics approval

Ethics application status

Summary

Brief summary

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

Trial website

https://clinicaltrials.gov/study/NCT03626545

Public notes

Contacts

Principal investigator

Name

Novartis Pharmaceuticals

Address

Novartis Pharmaceuticals

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol
Statistical analysis plan

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03626545

Register a trial

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03626545