Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)

Who is this study for? Patients with Non-Small-Cell Lung Cancer
What treatments are being studied? PDR001+Cisplatin
Status: Terminated
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient has stage IIIB (and is not a candidate for definitive multimodality therapy) or has stage IV NSCLC or relapsed locally advanced or metastatic NSCLC as follows:

‣ Group A, group B and group C only: Patients not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, targeted therapy, monoclonal antibody therapy including immunotherapy (e.g. PD-1/PD-L1 inhibitors) or targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion 4.

⁃ Group D only: Patients who have received only one prior systemic therapy treatment consisting of a PD-1 and/or PD-L1 inhibitor with or without a CTLA4 inhibitor for NSCLC, with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion 4. The last dose of prior immunotherapy must have been administered at least 6 weeks prior to the start of study treatment (cycle 1 day 1).

• Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR Wild-type, ALK-negative rearrangement and ROS1-negative rearrangement

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Patients with at least 1 measurable tumor lesion as assessed by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) according to RECIST 1.1.

Locations
United States
Arkansas
Highlands Oncology Group
Fayetteville
California
UCLA Santa Monica Hematology / Oncology SC-2
Santa Monica
Stanford Cancer Center SC
Stanford
Michigan
Henry Ford Health System SC
Detroit
Missouri
Washington University School of Medicine SC
Saint Louis
Other Locations
Belgium
Novartis Investigative Site
Leuven
Novartis Investigative Site
Roeselare
Canada
Novartis Investigative Site
Toronto
France
Novartis Investigative Site
Lyon Cedex
Novartis Investigative Site
Marseille Cedex 05
Germany
Novartis Investigative Site
Gottingen
Novartis Investigative Site
Koeln
Hong Kong Special Administrative Region
Novartis Investigative Site
Pokfulam
Italy
Novartis Investigative Site
Aviano
Novartis Investigative Site
Meldola
Novartis Investigative Site
Rozzano
Netherlands
Novartis Investigative Site
Amsterdam
Republic of Korea
Novartis Investigative Site
Seoul
Singapore
Novartis Investigative Site
Singapore
Spain
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Madrid
Time Frame
Start Date: 2017-05-24
Completion Date: 2021-07-28
Participants
Target number of participants: 111
Treatments
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
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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