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.
TerminatedPhase 2Results postedLast updated 20 June 2024
What this trial tests
Phase 2 trial testing Canakinumab in Non-small Cell Lung Cancer in 88 participants. Terminated before completion.
18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Canakinumab Monotherapy and in Combination With Pembrolizumab Based on Central ReviewPrimary· 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.
Group
Value
95% CI
Canakinumab Monotherapy
2.9
0.07 – 14.92
Canakinumab + Pembrolizumab
17.1
6.56 – 33.65
Canakinumab Antidrug Antibodies (ADA) PrevalenceSecondary· Predose (0 hour) on Day 1 of Cycle 1 (Cycle=21 days)
Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had a canakinumab ADA positive result at baseline
Group
Value
95% CI
Canakinumab Monotherapy
0
Canakinumab + Pembrolizumab
0
Canakinumab ADA IncidenceSecondary· 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
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)
Group
Value
95% CI
Canakinumab Monotherapy
1
Canakinumab + Pembrolizumab
0
Pembrolizumab ADA PrevalenceSecondary· Predose (0 hour) on Day 1 of Cycle 1 (Cycle = 21 days)
Pembrolizumab ADA prevalence at baseline was calculated as the percentage of participants who had a pembrolizumab ADA positive result at baseline
Group
Value
95% CI
Canakinumab + Pembrolizumab
4
Pembrolizumab Monotherapy
3
Pembrolizumab ADA IncidenceSecondary· 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
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)
Group
Value
95% CI
Canakinumab + Pembrolizumab
3
Pembrolizumab Monotherapy
4
Overall Response Rate (ORR) Based on Local Investigator Assessment Using RECIST v1.1Secondary· From date of randomization to date of surgery, assessed up to 6 weeks
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
Group
Value
95% CI
Canakinumab Monotherapy
0
0.00 – 10.00
Canakinumab + Pembrolizumab
8.6
1.80 – 23.06
Pembrolizumab Monotherapy
11.1
1.38 – 34.71
Serum Canakinumab ConcentrationSecondary· Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle =21 days)
Canakinumab serum concentrations were determined at the specified time points.
Cycle 1
Group
Value
95% CI
Canakinumab Monotherapy
0
± 0
Canakinumab + Pembrolizumab
0
± 0
Cycle 2
Group
Value
95% CI
Canakinumab Monotherapy
10.9
± 32.9
Canakinumab + Pembrolizumab
10.3
± 41.0
Serum Pembrolizumab ConcentrationSecondary· Predose (0 hour) and 0.5 hours post dose on Day 1 of Cycle 1 and predose on Cycle 2 (Cycle =21 days)
Pembrolizumab serum concentrations were determined at the specified time points.
Cycle 1 predose
Group
Value
95% CI
Canakinumab + Pembrolizumab
0
± 0
Pembrolizumab Monotherapy
0
± 0
Cyle 1 0.5 hours post dose
Group
Value
95% CI
Canakinumab + Pembrolizumab
65.5
± 23.8
Pembrolizumab Monotherapy
65.5
± 19.9
Cycle 2 predose
Group
Value
95% CI
Canakinumab + Pembrolizumab
16.0
± 43.4
Pembrolizumab Monotherapy
35.5
± 13.7
Surgical Feasibility RateSecondary· Up to 6 weeks after first dose
Surgical feasibility rate was defined as the percentage of subjects who underwent surgery following study treatment.
Group
Value
95% CI
Canakinumab Monotherapy
91.4
76.94 – 98.20
Canakinumab + Pembrolizumab
97.1
85.08 – 99.93
Pembrolizumab Monotherapy
100
81.47 – 100.00
Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Pembrolizumab Monotherapy Based on Central ReviewSecondary· At time of surgery (up to 6 weeks after first dose)
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.
Group
Value
95% CI
Pembrolizumab Monotherapy
16.7
3.58 – 41.42
Difference in Major Pathological Response (MPR) Rate Between the Canakinumab Plus Pembrolizumab Arm and the Pembrolizumab Arm Based on Central ReviewSecondary· At time of surgery (up to 6 weeks after first dose of study treatment)
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.
Group
Value
95% CI
Canakinumab + Pembrolizumab
17.1
6.56 – 33.65
Pembrolizumab Monotherapy
16.7
3.58 – 41.42
Major Pathological Response (MPR) Rate at the Time of Surgery in All Subjects Based on Local ReviewSecondary· At time of surgery (up to 6 weeks after first dose)
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.
Group
Value
95% CI
Canakinumab Monotherapy
0
0.00 – 10.00
Canakinumab + Pembrolizumab
20.0
8.44 – 36.94
Pembrolizumab Monotherapy
22.2
6.41 – 47.64
Adverse events — posted to ClinicalTrials.gov
Time frame: From day of first dose of study medication to 130 days after last dose of study medication, up to 25.6 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06038526 — Evaluation of Canakinumab in High-Risk Former-Smokers
· Phase 2
· active not recruiting
NCT05984602 — A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclit
· Phase 1
· active not recruiting
NCT05401578 — Canakinumab for the Treatment of Postprandial Hypoglycemia
· Phase 3
· recruiting
NCT05641831 — Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPA
· Phase 2
· recruiting
NCT05535738 — Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
· Phase 2, PHASE3
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 20 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03968419.