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

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ClinicalTrials.gov Identifier: NCT03064854
Recruitment Status : Active, not recruiting
First Posted : February 27, 2017
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: PDR001 Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Drug: Canakinumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : December 10, 2021
Estimated Study Completion Date : December 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: squamous, gem/cis+PDR001 Drug: PDR001
Powder for solution for infusion

Drug: Cisplatin
Intravenous infusion

Drug: Gemcitabine
Intravenous infusion

Experimental: Group B: non-squamous, pem/cis+PDR001 Drug: PDR001
Powder for solution for infusion

Drug: Cisplatin
Intravenous infusion

Drug: Pemetrexed
Intravenous infusion

Experimental: Group C: paclitaxel/carbo+PDR001 Drug: PDR001
Powder for solution for infusion

Drug: Carboplatin
Intravenous infusion

Drug: Paclitaxel
Intravenous infusion

Experimental: Group E: non-squamous, pem/cis (or carbo)+PDR001+canakinumab Drug: PDR001
Powder for solution for infusion

Drug: Cisplatin
Intravenous infusion

Drug: Pemetrexed
Intravenous infusion

Drug: Carboplatin
Intravenous infusion

Drug: Canakinumab
Subcutaneous injection




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) during the first 6 weeks of therapy [ Time Frame: 42 days ]
  2. Overall response rate (ORR) [ Time Frame: every 6 weeks for up to 28 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) per Investigator [ Time Frame: every 6 weeks for up to 28 months ]
  2. Disease Control Rate (DCR) per Investigator [ Time Frame: every 6 weeks for up to 28 months ]
  3. Duration of Response (DOR) per Investigator [ Time Frame: every 6 weeks for up to 28 months ]
  4. Time to Response (TTR) per Investigator [ Time Frame: every 6 weeks for up to 28 months ]
  5. Overall survival (OS) [ Time Frame: from date of start of treatment to date of death due to any cause (up to 28 months) ]
  6. Peak Serum Concentration (Cmax) (PDR001) [ Time Frame: Day 1 of Cycle 1 and 4 of induction phase cycle = 21 days ]
  7. Peak Plasma Concentration (Cmax) (chemotherapy) [ Time Frame: Day 1 of Cycle 1, 3 and 4; cycle = 21 days ]
  8. Antidrug antibodies (ADA) prevalence at baseline [ Time Frame: Baseline ]
  9. ADA incidence on treatment [ Time Frame: Throughout study until 150 day safety follow-up ]
  10. Trough Serum Concentration (Cmin) (PDR001) [ Time Frame: Day 1 of Cycle 1 to 4 of induction phase; Day 1 of Cycle 1 to 4, 6, 8 and every 6 cycle afterwards of maintenance phase; cycle = 21 days ]
  11. Trough PlasmaConcentration (Cmin) (chemotherapy) [ Time Frame: Day 1 of Cycle 1, 3 and 4; Cycle = 21 days ]
  12. Progression Free Survival (PDF) by blinded independend review commitee (BIRC) [ Time Frame: every 6 weeks for up to 28 months ]
  13. Overall response rate (ORR) by blinded independend review commitee (BIRC) [ Time Frame: every 6 weeks for up to 28 months ]
  14. Disease control rate (DCR) by blinded independend review commitee (BIRC) [ Time Frame: every 6 weeks for up to 28 months ]
  15. Duration of Response (DOR) by blinded independend review commitee (BIRC) [ Time Frame: every 6 weeks for up to 28 months ]
  16. Time to Response (TTR) by blinded independend review commitee (BIRC) [ Time Frame: every 6 weeks for up to 28 months ]
  17. Incidence of AEs (CTCAE v4.03) [ Time Frame: through study completion, an average of one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064854


  Show 25 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03064854     History of Changes
Other Study ID Numbers: CPDR001C2101
2016-002815-17 ( EudraCT Number )
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PDR001
immunotherapy
Non-small cell lung cancer
lung
NSCLC
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists