PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/3/2019 |
Start Date: | May 24, 2017 |
End Date: | December 10, 2021 |
Contact: | Novartis Pharmaceuticals |
Email: | novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
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)
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.
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.
Main Inclusion Criteria:
1. 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:
1. 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.
2. 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).
2. Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR Wild-type,
ALK-negative rearrangement and ROS1-negative rearrangement
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4. 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:
1. 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
2. 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.
3. 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).
4. History of leptomeningeal metastases
5. 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).
6. Use of any live vaccines against infectious diseases within 4 weeks of initiation of
study treatment
We found this trial at
7
sites
Detroit, Michigan 48202
Principal Investigator: Igor Rybkin
Phone: 313-916-8862
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Fayetteville, Arkansas 72703
Principal Investigator: Eric S S Schaefer
Phone: 479-587-1700
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Philadelphia, Pennsylvania 19111
Principal Investigator: Hossein Borghaei
Phone: 215-728-2769
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Daniel Morgensztern
Phone: 314-747-1864
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Santa Monica, California 90404
Principal Investigator: Edward B. Garon
Phone: T:310-825-2903
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Stanford, California 94305
Principal Investigator: Heather Ann Wakelee
Phone: 650-723-0270
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