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

Not Recruiting

Trial ID: NCT03064854


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.

Official Title

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)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology


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

   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


drug: PDR001

drug: Cisplatin

drug: Gemcitabine

drug: Pemetrexed

drug: Carboplatin

drug: Paclitaxel

drug: Canakinumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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