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Monoclonal Antibodies

Pembrolizumab monotherapy for Non-Small Cell Lung Cancer (CANOPY-N Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

CANOPY-N Trial Summary

This study is evaluating whether a drug which blocks inflammation may help treat cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

CANOPY-N Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CANOPY-N Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Canakinumab ADA Incidence
Canakinumab Antidrug Antibodies (ADA) Prevalence
Difference in Major Pathological Response (MPR) Rate Between the Canakinumab Plus Pembrolizumab Arm and the Pembrolizumab Arm Based on Central Review
+9 more

CANOPY-N Trial Design

3Treatment groups
Experimental Treatment
Group I: Pembrolizumab monotherapyExperimental Treatment1 Intervention
Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery
Group II: Canakinumab monotherapyExperimental Treatment1 Intervention
Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery
Group III: Canakinumab + pembrolizumabExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,501 Total Patients Enrolled

Frequently Asked Questions

~16 spots leftby Mar 2025