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.

Part of paid clinical trials in La Jolla, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03968419
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks
  • Pembrolizumab — DRUG
    200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks

Study Details

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.

Key Dates

Start date
Nov 5, 2019
Status verified
Jun 2024
Primary completion
Apr 20, 2022
Completion
Aug 15, 2022

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab monotherapy
    Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery
  • Experimental: 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
  • Experimental: Pembrolizumab monotherapy
    Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery

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) ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCLA Oncology HematologyLa JollaCalifornia92037-
University of Kansas Medical Center Neurology Dept.Kansas CityKansas66160-
SUNY - Upstate Medical UniversitySyracuseNew York13210-
Methodist Hospital / Methodist Cancer CenterHoustonTexas77030-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UCLA Oncology Hematology· La Jolla, CAUniversity of Kansas Medical Center Neurology Dept.· Kansas City, KSSUNY - Upstate Medical University· Syracuse, NYMethodist Hospital / Methodist Cancer Center· Houston, TX

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