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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03064854
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • PDR001 — DRUG
    Powder for solution for infusion
  • Cisplatin — DRUG
    Intravenous infusion
  • Gemcitabine — DRUG
    Intravenous infusion
  • Pemetrexed — DRUG
    Intravenous infusion
  • Carboplatin — DRUG
    Intravenous infusion
  • Paclitaxel — DRUG
    Intravenous infusion
  • Canakinumab — DRUG
    Subcutaneous injection

Study Details

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.

Key Dates

Start date
May 24, 2017
Status verified
Aug 2022
Primary completion
Jul 28, 2021
Completion
Jul 28, 2021

Study Design

Enrollment
111 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: squamous, gem/cis+PDR001
  • Experimental: Group B: non-squamous, pem/cis+PDR001
  • Experimental: Group C: paclitaxel/carbo+PDR001
  • Experimental: Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab

Primary Outcome Measure

Dose Limiting Toxicities (DLTs) during the first 6 weeks of therapy [ Time Frame: 42 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
UCLA Santa Monica Hematology / Oncology SC-2Santa MonicaCalifornia90404-
Stanford Cancer Center SCStanfordCalifornia94305-
Henry Ford Health System SCDetroitMichigan48202-
Washington University School of Medicine SCSt LouisMissouri63110-

Find similar trials in Fayetteville, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group· Fayetteville, ARUCLA Santa Monica Hematology / Oncology SC-2· Santa Monica, CAStanford Cancer Center SC· Stanford, CAHenry Ford Health System SC· Detroit, MIWashington University School of Medicine SC· St Louis, MO

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