PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients
NCT ID: NCT03064854
Last Updated: 2022-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
111 participants
INTERVENTIONAL
2017-05-24
2021-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: squamous, gem/cis+PDR001
PDR001
Powder for solution for infusion
Cisplatin
Intravenous infusion
Gemcitabine
Intravenous infusion
Group B: non-squamous, pem/cis+PDR001
PDR001
Powder for solution for infusion
Cisplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
Group C: paclitaxel/carbo+PDR001
PDR001
Powder for solution for infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab
PDR001
Powder for solution for infusion
Cisplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
Carboplatin
Intravenous infusion
Canakinumab
Subcutaneous injection
Interventions
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PDR001
Powder for solution for infusion
Cisplatin
Intravenous infusion
Gemcitabine
Intravenous infusion
Pemetrexed
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
Canakinumab
Subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
UCLA Santa Monica Hematology / Oncology SC-2
Santa Monica, California, United States
Stanford Cancer Center SC
Stanford, California, United States
Henry Ford Health System SC
Detroit, Michigan, United States
Washington University School of Medicine SC
St Louis, Missouri, United States
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Roeselare, , Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Göttingen, , Germany
Novartis Investigative Site
Pokfulam, Hong Kong, Hong Kong
Novartis Investigative Site
Meldola, FC, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Aviano, PN, Italy
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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References
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Santoro A, Pilar G, Tan DSW, Zugazagoitia J, Shepherd FA, Bearz A, Barlesi F, Kim TM, Overbeck TR, Felip E, Cai C, Eddy S, McCulloch T, Schaefer ES. Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC. BMC Cancer. 2024 Oct 24;24(1):1307. doi: 10.1186/s12885-024-12841-2.
Related Links
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Results for CPDR001C2101 from the Novartis Clinical Trial Website
A Plain Language Trial Summary is available on novctrd.com
Other Identifiers
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2016-002815-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CPDR001C2101
Identifier Type: -
Identifier Source: org_study_id
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