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PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients

NCT03064854 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2022-08-15

No results posted yet for this study

Summary

The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.

Conditions

Interventions

DRUG

PDR001

Powder for solution for infusion

DRUG

Cisplatin

Intravenous infusion

DRUG

Gemcitabine

Intravenous infusion

DRUG

Pemetrexed

Intravenous infusion

DRUG

Carboplatin

Intravenous infusion

DRUG

Paclitaxel

Intravenous infusion

DRUG

Canakinumab

Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2021-07-28
Completion
2021-07-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Singapore
  • South Korea
  • Spain

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 NCT03064854 on ClinicalTrials.gov