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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

NCT03631199 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 673

Last updated 2026-02-25

Study results available
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Summary

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.

Conditions

Interventions

DRUG

canakinumab

canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)

DRUG

canakinumab-matching placebo

canakinumab placebo every 3 weeks (squamous and non-squamous)

DRUG

pembrolizumab

200 mg every 3 weeks (squamous and non-squamous)

DRUG

carboplatin

Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)

DRUG

cisplatin

75 mg/m\^2 every 3 weeks (non-squamous)

DRUG

paclitaxel

200 mg/m\^2 every 3 weeks (squamous)

DRUG

nab-paclitaxel

100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)

DRUG

pemetrexed

500 mg/m\^2 every 3 weeks (non-squamous)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2021-08-09
Completion
2026-01-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Italy
  • Japan
  • Lebanon
  • Malaysia
  • Netherlands
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631199 on ClinicalTrials.gov