Non-small Cell Lung CancerPhase 2CANOPY-NNCT03968419
This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.
A Phase 2 study testing Canakinumab and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 29 sites in 12 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Canakinumab and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 29 sitesin 12 countries
- Study dates
- 5 Nov 2019to 15 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors.
- Subject must have been eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment).
- A mandatory newly obtained tissue biopsy from primary site was required for study enrollment. An archival biopsy was also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment.
- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
Who cannot join
- Subjects with unresectable or metastatic disease.
- History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
- Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening
- Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy was permitted
- Subject with suspected or proven immunocompromised state or infections
Trial locations and contacts
29 sites in 12 countries.
29 sites in 12 countries
United States4 sites
Methodist Hospital / Methodist Cancer Center
Houston, Texas, 77030
University of Kansas Medical Center Neurology Dept.
Kansas City, Kansas, 66160
UCLA Oncology Hematology
La Jolla, California, 92037
SUNY - Upstate Medical University
Syracuse, New York, 13210
Germany4 sites
Novartis Investigative Site
Bad Berka, 99437
Novartis Investigative Site
Cologne, 51109
Novartis Investigative Site
Giessen, 35392
Novartis Investigative Site
Halle, 06120
France3 sites
Novartis Investigative Site
Bron, 69677
Novartis Investigative Site
Montpellier, Herault, 34059
Novartis Investigative Site
Paris, 75679
Netherlands3 sites
Novartis Investigative Site
's-Hertogenbosch, 5200
Novartis Investigative Site
Breda, 4819 EV
Novartis Investigative Site
Maastricht, 6229 HX
Russia3 sites
Novartis Investigative Site
Omsk, 644013
Novartis Investigative Site
Saint Petersburg, 195271
Novartis Investigative Site
Saint Petersburg, 197022
Spain3 sites
Novartis Investigative Site
Jaén, Andalusia, 23007
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Oviedo, Principality of Asturias, 33011
Turkey (Türkiye)3 sites
Novartis Investigative Site
Izmir
Novartis Investigative Site
Sakarya, 54290
Novartis Investigative Site
Sihhiye / Ankara, 06100
Taiwan2 sites
Novartis Investigative Site
Taipei, 103616
Novartis Investigative Site
Taipei, 110
About this study
Official title: A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)
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.
Read the detailed description
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).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Canakinumab, Pembrolizumab
- Keywords
- ACZ885, canakinumab, pembrolizumab, NSCLC, non-small cell lung cancer, non small cell lung cancer, early stage NSCLC, squamous, non-squamous,, MPR, major pathological response, hs-CRP, PD-L1, hsCRP, surgery, neo-adjuvant, neo adjuvant, CD8, hs-IL-6, CANOPY
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called ACZ885
200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks
PembrolizumabDrug
200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab monotherapy | Experimental | Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery Receives: Drug: Canakinumab |
| 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 Receives: Drug: Canakinumab; Drug: Pembrolizumab |
| Pembrolizumab monotherapy | Experimental | Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of surgery (up to 6 weeks after first dose of study treatment)
Secondary outcomes (12)
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
Measured: Predose (0 hour) on Day 1 of Cycle 1 (Cycle=21 days)
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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of randomization up to 6 weeks after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start5 Nov 2019
- Primary completion20 Apr 2022
- Study completion15 Aug 2022
Why it stopped: Study early terminated due to low enrollment compared to the anticipated figures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968419
- Sponsor's protocol ID
- CACZ885V2201C
- Other IDs
- 2018-004813-42, 2018
- Acronym
- CANOPY-N
- Status last verified
- Jun 2024
- First submitted
- 15 May 2019
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33648347
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)
- ClinicalTrials.gov ID
- NCT03968419
- Acronym / sponsor ID
- CANOPY-N / CACZ885V2201C
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- ACZ885, canakinumab, pembrolizumab, NSCLC, non-small cell lung cancer, non small cell lung cancer, early stage NSCLC, squamous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study early terminated due to low enrollment compared to the anticipated figures.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Canakinumab monotherapy | Experimental | Drug: CanakinumabParticipants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery |
| Canakinumab + pembrolizumab | Experimental | Drug: Canakinumab, Drug: PembrolizumabParticipants 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 | Drug: PembrolizumabParticipants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors.
- Subject must have been eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment).
- A mandatory newly obtained tissue biopsy from primary site was required for study enrollment. An archival biopsy was also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment.
- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
Key exclusion criteria (5 listed)
- Subjects with unresectable or metastatic disease.
- History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
- Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening
- Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy was permitted
- Subject with suspected or proven immunocompromised state or infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabAlso: ACZ885200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks | Drug | Canakinumab + pembrolizumab, Canakinumab monotherapy |
| Pembrolizumab200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks | Drug | Canakinumab + pembrolizumab, Pembrolizumab monotherapy |
Primary outcome
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
Time frame: At time of surgery (up to 6 weeks after first dose of study treatment)
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.
12 secondary outcomes
Canakinumab Antidrug Antibodies (ADA) Prevalence
Time frame: Predose (0 hour) on Day 1 of Cycle 1 (Cycle=21 days)
Canakinumab ADA Incidence
Time frame: 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
Time frame: Predose (0 hour) on Day 1 of Cycle 1 (Cycle = 21 days)
Pembrolizumab ADA Incidence
Time frame: 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
Time frame: From date of randomization to date of surgery, assessed up to 6 weeks
Serum Canakinumab Concentration
Time frame: Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle =21 days)
Serum Pembrolizumab Concentration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At time of surgery (up to 6 weeks after first dose)
Major Pathological Response (MPR) Rate Based on the Levels of Biomarkers
Time frame: From date of randomization up to 6 weeks after first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33648347Garrido 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.
- Plain Language Trial SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
29 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 29 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, France, Netherlands, Russia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At time of surgery (up to 6 weeks after first dose of study treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.