PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients
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.
Checked against the public recordLast updated Aug 15, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: PDR001; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Canakinumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology GroupFayetteville, Arkansas
- UCLA Santa Monica Hematology / Oncology SC-2Santa Monica, California
- Stanford Cancer Center SCStanford, California
- Henry Ford Health System SCDetroit, Michigan
- Washington University School of Medicine SCSt Louis, Missouri
- Novartis Investigative SiteLeuven
- Novartis Investigative SiteRoeselare
- Novartis Investigative SiteToronto, Ontario
- Novartis Investigative SitePrague
- Novartis Investigative SiteLyon
- Novartis Investigative SiteMarseille
- Novartis Investigative SiteCologne
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 15, 2022. Always confirm current availability with the study team.