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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004813-42 | EudraCT Number |
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Study early terminated due to low enrollment compared to the anticipated figures.
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The purpose of this study was to evaluate the major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR of pembrolizumab as a single agent and the dynamic of the tumor microenvironment changes on treatment.
This was a randomized, phase II, open-label study evaluating canakinumab, an anti-IL-1β monoclonal antibody, or pembrolizumab, a monoclonal antibody designed to block the PD-1 receptor, as monotherapy or in combination as neoadjuvant therapy. The study population included adult subjects with resectable non-small cell lung cancer (NSCLC) planned for surgery in approximately 4-6 weeks. Subjects were treated for a maximum duration of 6 weeks (2 cycles) until surgery, progression, unacceptable toxicity or discontinuation from the study treatment for any other reason.
Subjects were randomized in a 2:2:1 ratio to one of the 3 treatment arms (canakinumab alone or canakinumab in combination with pembrolizumab or pembrolizumab alone). Surgery was performed between 4 to 6 weeks after the first dose of study treatment.
All randomized subjects were followed for safety for up to 130 days following the last dose of study treatment (safety follow-up period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab monotherapy | Experimental | Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery |
|
| Canakinumab + pembrolizumab | Experimental | Participants received 200 mg of canakinumab in combination with 200 mg of pembrolizumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery |
|
| Pembrolizumab monotherapy | Experimental | Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canakinumab | Drug | 200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Canakinumab Monotherapy and in Combination With Pembrolizumab Based on Central Review | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR was assessed at the time of surgery in all subjects randomized to canakinumab monotherapy and in combination with pembrolizumab based on central review. | At time of surgery (up to 6 weeks after first dose of study treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Canakinumab Antidrug Antibodies (ADA) Prevalence | Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had a canakinumab ADA positive result at baseline | Predose (0 hour) on Day 1 of Cycle 1 (Cycle=21 days) |
| Canakinumab ADA Incidence |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Oncology Hematology | La Jolla | California | 92037 | United States | ||
| University of Kansas Medical Center Neurology Dept. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33648347 | Derived | Garrido P, Pujol JL, Kim ES, Lee JM, Tsuboi M, Gomez-Rueda A, Benito A, Moreno N, Gorospe L, Dong T, Blin C, Rodrik-Outmezguine V, Passos VQ, Mok TS. Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design. Future Oncol. 2021 Apr;17(12):1459-1472. doi: 10.2217/fon-2020-1098. Epub 2021 Mar 2. |
| Label | URL |
|---|---|
| Plain Language Trial Summary | View source |
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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.
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Screening assessments were done within 28 days prior to randomization. A total of 163 participants were screened. Of them, 88 participants were randomized. After treatment completion or discontinuation, all subjects were followed for safety for up to 130 days following the last dose of study treatment (safety follow-up period).
The study was conducted in 29 centers across 12 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab Monotherapy | Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery |
| FG001 | Canakinumab + Pembrolizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2020 | Jun 12, 2023 |
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|
| Pembrolizumab | Drug | 200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks |
|
Canakinumab ADA incidence on treatment was calculated as the percentage of participants who were canakinumab treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and canakinumab 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) |
| From baseline (Predose on Day 1 of Cycle 1) up to 130 days after last dose of study treatment (assessed up to 24.6 weeks). Cycle = 21 days |
| Pembrolizumab ADA Prevalence | Pembrolizumab ADA prevalence at baseline was calculated as the percentage of participants who had a pembrolizumab ADA positive result at baseline | Predose (0 hour) on Day 1 of Cycle 1 (Cycle = 21 days) |
| Pembrolizumab ADA Incidence | Pembrolizumab ADA incidence on treatment was calculated as the percentage of participants who were pembrolizumab treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and pembrolizumab 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) | From baseline (Predose on Day 1 of Cycle 1) up to 26 days after last dose of study treatment (assessed up to 10.7 weeks). Cycle = 21 days |
| Overall Response Rate (ORR) Based on Local Investigator Assessment Using RECIST v1.1 | ORR is defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per local investigator's assessment by RECIST 1.1. 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 | From date of randomization to date of surgery, assessed up to 6 weeks |
| Serum Canakinumab Concentration | Canakinumab serum concentrations were determined at the specified time points. | Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle =21 days) |
| Serum Pembrolizumab Concentration | Pembrolizumab serum concentrations were determined at the specified time points. | Predose (0 hour) and 0.5 hours post dose on Day 1 of Cycle 1 and predose on Cycle 2 (Cycle =21 days) |
| Surgical Feasibility Rate | Surgical feasibility rate was defined as the percentage of subjects who underwent surgery following study treatment. | Up to 6 weeks after first dose |
| Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Pembrolizumab Monotherapy Based on Central Review | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR was assessed at the time of surgery in all subjects randomized to pembrolizumab monotherapy arm based on central review. | At time of surgery (up to 6 weeks after first dose) |
| Difference in Major Pathological Response (MPR) Rate Between the Canakinumab Plus Pembrolizumab Arm and the Pembrolizumab Arm Based on Central Review | MPR was defined as the percentage of participants with ≤10% residual viable tumor cells on surgical samples. MPR was assessed at the time of surgery based on central review. The difference in MPR rate between the canakinumab plus pembrolizumab arm and the pembrolizumab arm based on central review along with the Chang and Zhang confidence interval was assessed. | At time of surgery (up to 6 weeks after first dose of study treatment) |
| Major Pathological Response (MPR) Rate at the Time of Surgery in All Subjects Based on Local Review | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR was assessed at the time of surgery in all subjects based on local review. | At time of surgery (up to 6 weeks after first dose) |
| Major Pathological Response (MPR) Rate Based on the Levels of Biomarkers | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR rate was analyzed by the biomarker subgroups at baseline. Biomarkers included PD-L1, CD8, hs-CRP and hs-IL-6. | From date of randomization up to 6 weeks after first dose |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| SUNY - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Methodist Hospital / Methodist Cancer Center | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Montreal | Quebec | H2W 1T8 | Canada |
| Novartis Investigative Site | Montpellier | Herault | 34059 | France |
| Novartis Investigative Site | Bron | 69677 | France |
| Novartis Investigative Site | Paris | 75679 | France |
| Novartis Investigative Site | Bad Berka | 99437 | Germany |
| Novartis Investigative Site | Cologne | 51109 | Germany |
| Novartis Investigative Site | Giessen | 35392 | Germany |
| Novartis Investigative Site | Halle | 06120 | Germany |
| Novartis Investigative Site | Thessaloniki | 57001 | Greece |
| Novartis Investigative Site | Kashiwa | Chiba | 277 8577 | Japan |
| Novartis Investigative Site | 's-Hertogenbosch | 5200 | Netherlands |
| Novartis Investigative Site | Breda | 4819 EV | Netherlands |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Omsk | 644013 | Russia |
| Novartis Investigative Site | Saint Petersburg | 195271 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Jaén | Andalusia | 23007 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Taipei | 103616 | Taiwan |
| Novartis Investigative Site | Taipei | 110 | Taiwan |
| Novartis Investigative Site | Izmir | Turkey (Türkiye) |
| Novartis Investigative Site | Sakarya | 54290 | Turkey (Türkiye) |
| Novartis Investigative Site | Sihhiye / Ankara | 06100 | Turkey (Türkiye) |
Participants received 200 mg of canakinumab in combination with 200 mg of pembrolizumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery
| FG002 | Pembrolizumab Monotherapy | Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab Monotherapy | Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery |
| BG001 | Canakinumab + Pembrolizumab | Participants received 200 mg of canakinumab in combination with 200 mg of pembrolizumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery |
| BG002 | Pembrolizumab Monotherapy | Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Canakinumab Monotherapy and in Combination With Pembrolizumab Based on Central Review | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR was assessed at the time of surgery in all subjects randomized to canakinumab monotherapy and in combination with pembrolizumab based on central review. | All subjects who were randomized to canakinumab monotherapy or canakinumab in combination with pembrolizumab | Posted | Number | 95% Confidence Interval | Percentage of participants | At time of surgery (up to 6 weeks after first dose of study treatment) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Canakinumab Antidrug Antibodies (ADA) Prevalence | Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had a canakinumab ADA positive result at baseline | All subjects randomized to canakinumab monotherapy or canakinumab in combination with pembrolizumab who received at least one dose of canakinumab. | Posted | Count of Participants | Participants | Predose (0 hour) on Day 1 of Cycle 1 (Cycle=21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Canakinumab ADA Incidence | Canakinumab ADA incidence on treatment was calculated as the percentage of participants who were canakinumab treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and canakinumab 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) | All subjects randomized to canakinumab monotherapy or canakinumab in combination with pembrolizumab who received at least one dose of canakinumab. | Posted | Count of Participants | Participants | From baseline (Predose on Day 1 of Cycle 1) up to 130 days after last dose of study treatment (assessed up to 24.6 weeks). Cycle = 21 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pembrolizumab ADA Prevalence | Pembrolizumab ADA prevalence at baseline was calculated as the percentage of participants who had a pembrolizumab ADA positive result at baseline | All subjects randomized to canakinumab in combination with pembrolizumab or pembrolizumab monotherapy who received at least one dose of pembrolizumab. | Posted | Count of Participants | Participants | Predose (0 hour) on Day 1 of Cycle 1 (Cycle = 21 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pembrolizumab ADA Incidence | Pembrolizumab ADA incidence on treatment was calculated as the percentage of participants who were pembrolizumab treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and pembrolizumab 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) | All subjects randomized to canakinumab in combination with pembrolizumab or pembrolizumab monotherapy who received at least one dose of pembrolizumab. | Posted | Count of Participants | Participants | From baseline (Predose on Day 1 of Cycle 1) up to 26 days after last dose of study treatment (assessed up to 10.7 weeks). Cycle = 21 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) Based on Local Investigator Assessment Using RECIST v1.1 | ORR is defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per local investigator's assessment by RECIST 1.1. 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 | FAS including all subjects to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization to date of surgery, assessed up to 6 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Serum Canakinumab Concentration | Canakinumab serum concentrations were determined at the specified time points. | All participants who received at least one dose of canakinumab with at least one evaluable pharmacokinetic (PK) sample. Number analyzed corresponds to the number of participants with an evaluable PK sample at the specified time point | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/miliLiter (ug/mL) | Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle =21 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Serum Pembrolizumab Concentration | Pembrolizumab serum concentrations were determined at the specified time points. | All participants who received at least one dose of pembrolizumab with at least one evaluable PK sample. Number analyzed corresponds to the number of participants with an evaluable PK sample at the specified time point | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Predose (0 hour) and 0.5 hours post dose on Day 1 of Cycle 1 and predose on Cycle 2 (Cycle =21 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Surgical Feasibility Rate | Surgical feasibility rate was defined as the percentage of subjects who underwent surgery following study treatment. | FAS including all subjects to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 6 weeks after first dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Pembrolizumab Monotherapy Based on Central Review | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR was assessed at the time of surgery in all subjects randomized to pembrolizumab monotherapy arm based on central review. | All subjects who were randomized to pembrolizumab monotherapy arm | Posted | Number | 95% Confidence Interval | Percentage of participants | At time of surgery (up to 6 weeks after first dose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Difference in Major Pathological Response (MPR) Rate Between the Canakinumab Plus Pembrolizumab Arm and the Pembrolizumab Arm Based on Central Review | MPR was defined as the percentage of participants with ≤10% residual viable tumor cells on surgical samples. MPR was assessed at the time of surgery based on central review. The difference in MPR rate between the canakinumab plus pembrolizumab arm and the pembrolizumab arm based on central review along with the Chang and Zhang confidence interval was assessed. | All subjects who were randomized to canakinumab in combination with pembrolizumab or pembrolizumab monotherapy arms | Posted | Number | 95% Confidence Interval | Percentage of participants | At time of surgery (up to 6 weeks after first dose of study treatment) |
|
| |||||||||||||||||||||||||||||
| Secondary | Major Pathological Response (MPR) Rate at the Time of Surgery in All Subjects Based on Local Review | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR was assessed at the time of surgery in all subjects based on local review. | FAS including all subjects to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | At time of surgery (up to 6 weeks after first dose) |
| ||||||||||||||||||||||||||||||
| Secondary | Major Pathological Response (MPR) Rate Based on the Levels of Biomarkers | MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had >10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR rate was analyzed by the biomarker subgroups at baseline. Biomarkers included PD-L1, CD8, hs-CRP and hs-IL-6. | All subjects to whom study treatment was assigned by randomization. Number analyzed is the number of participants with data available for analysis for each category | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization up to 6 weeks after first dose |
|
From day of first dose of study medication to 130 days after last dose of study medication, up to 25.6 weeks
Any sign or symptom that occurs during the study treatment plus the 130 days post treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Canakinumab Monotherapy | Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery | 3 | 35 | 10 | 35 | 28 | 35 |
| EG001 | Canakinumab + Pembrolizumab | Participants received 200 mg of canakinumab in combination with 200 mg of pembrolizumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery | 2 | 35 | 9 | 35 | 27 | 35 |
| EG002 | Pembrolizumab Monotherapy | Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery | 1 | 18 | 4 | 18 | 14 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pyopneumothorax | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| SARS-CoV-2 test negative | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2022 | Jun 12, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C541220 | canakinumab |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Unknown |
|
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| Participants |
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| Participants |
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Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery |
|
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