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

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)

ClinicalTrials.gov Identifier: NCT03064854

Novartis Reference Number: CPDR001C2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Non-small Cell Lung Cancer
Phase 
Phase 1
Overall status 
Active, not recruiting
Enrollment count 
112 participants
Start date 
May 24, 2017
Completion date 
Nov 06, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

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

Eligibility Criteria

Main Inclusion Criteria:

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.

Main Exclusion Criteria:

Patient with a history of severe hypersensitivity reaction to the planned study treatment including gemcitabine, paclitaxel, cisplatin, carboplatin, pemetrexed or any known excipients of these drugs
History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
History of leptomeningeal metastases
Active, known or suspected autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll).
Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment

Study Locations

United States
Highlands Oncology Group
-
Fayetteville, 72703
Arkansas
United States
UCLA Santa Monica Hematology / Oncology SC-2
-
Santa Monica, 90404
California
United States
Stanford Cancer Center SC
-
Stanford, 94305
California
United States
Henry Ford Health System SC
-
Detroit, 48202
Michigan
United States
Washington University School of Medicine SC
-
Saint Louis, 63110
Missouri
United States
Fox Chase Cancer Center SC
-
Philadelphia, 19111
Pennsylvania
United States
Belgium
Novartis Investigative Site
-
Leuven, 3000
-
Belgium
Novartis Investigative Site
-
Roeselare, 8800
-
Belgium
Canada
Novartis Investigative Site
-
Toronto, M5G 2M9
Ontario
Canada
Czechia
Novartis Investigative Site
-
Praha 4, 140 59
-
Czechia
France
Novartis Investigative Site
-
Lyon Cedex, 69373
-
France
Novartis Investigative Site
-
Marseille cedex 05, 13385
-
France
Germany
Novartis Investigative Site
-
Gottingen, 37075
-
Germany
Novartis Investigative Site
-
Koeln, 51109
-
Germany
Hong Kong
Novartis Investigative Site
-
Pokfulam,
-
Hong Kong
Italy
Novartis Investigative Site
-
Meldola, 47014
FC
Italy
Novartis Investigative Site
-
Rozzano, 20089
MI
Italy
Novartis Investigative Site
-
Aviano, 33081
PN
Italy
Japan
Novartis Investigative Site
-
Koto ku, 135 8550
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
-
Seoul, 03080
-
Korea, Republic of
Netherlands
Novartis Investigative Site
-
Amsterdam, 1066 CX
-
Netherlands
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
-
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
-
Madrid, 28034
-
Spain
Novartis Investigative Site
-
Madrid, 28041
-
Spain

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