Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

Part of paid clinical trials in Long Beach, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03631199
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • canakinumab — DRUG
    canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)
  • canakinumab-matching placebo — DRUG
    canakinumab placebo every 3 weeks (squamous and non-squamous)
  • pembrolizumab — DRUG
    200 mg every 3 weeks (squamous and non-squamous)
  • carboplatin — DRUG
    Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)
  • cisplatin — DRUG
    75 mg/m\^2 every 3 weeks (non-squamous)
  • paclitaxel — DRUG
    200 mg/m\^2 every 3 weeks (squamous)
  • nab-paclitaxel — DRUG
    100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)
  • pemetrexed — DRUG
    500 mg/m\^2 every 3 weeks (non-squamous)

Study Details

This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.

Key Dates

Start date
Dec 21, 2018
Status verified
Feb 2026
Primary completion
Aug 9, 2021
Completion
Jan 26, 2026

Study Design

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

Arms

  • Experimental: Part 1: Cohort A
    Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
  • Experimental: Part 1: Cohort B
    Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
  • Experimental: Part 1: Cohort C
    Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
  • Experimental: Part 2: Canakinumab+pembro+CTx
    Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
  • Other: Part 2: Placebo+pembro+CTx
    Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.

Primary Outcome Measure

Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: During the first 42 days of dosing ]

Locations (4)

FacilityCityStateZIPSite coordinators
Pacific Shores Medical GroupLong BeachCalifornia90813-
USC Kenneth Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
AdventHealthOrlandoFlorida32804-
Dana Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Long Beach, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Pacific Shores Medical Group· Long Beach, CAUSC Kenneth Norris Comprehensive Cancer Center· Los Angeles, CAAdventHealth· Orlando, FLDana Farber Cancer Institute· Boston, MA

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