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Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (CANOPY-1)

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ClinicalTrials.gov Identifier: NCT03631199
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: canakinumab Drug: canakinumab matching placebo Drug: pembrolizumab Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: nab-paclitaxel Drug: pemetrexed Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 627 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)
Estimated Study Start Date : December 28, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : October 21, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: canakinumab
canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy
Drug: canakinumab
canakinumab every 3 weeks (squamous and non-squamous)
Other Name: ACZ885

Drug: pembrolizumab
200 mg every 3 weeks (squamous and non-squamous)

Drug: carboplatin
AUC 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)

Drug: cisplatin
75 mg/m2 every 3 weeks (non-squamous)

Drug: paclitaxel
200 mg/m2 every 3 weeks (squamous)

Drug: nab-paclitaxel
100 mg/m2 every 3 weeks (squamous)

Drug: pemetrexed
500 mg/m2 every 3 weeks (non-squamous)

canakinumab matching-placebo
canakinumab matching-placebo in combination with pembrolizumab and platinum-based doublet chemotherapy
Drug: canakinumab matching placebo
canakinumab placebo every 3 weeks (squamous and non-squamous)

Drug: pembrolizumab
200 mg every 3 weeks (squamous and non-squamous)

Drug: carboplatin
AUC 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)

Drug: cisplatin
75 mg/m2 every 3 weeks (non-squamous)

Drug: paclitaxel
200 mg/m2 every 3 weeks (squamous)

Drug: nab-paclitaxel
100 mg/m2 every 3 weeks (squamous)

Drug: pemetrexed
500 mg/m2 every 3 weeks (non-squamous)




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLT) [ Time Frame: 6 months ]
  2. Progression free survival (PFS) per investigator assessment using RECIST v1.1 [ Time Frame: 18 months ]
    RECIST v1.1 = Response evaluation criteria in solid tumor v1.1

  3. Overall survival (OS) per investigator assessment using RECIST v1.1 [ Time Frame: 38 months ]
    RECIST v1.1 = Response evaluation criteria in solid tumor v1.1


Secondary Outcome Measures :
  1. Overall response rate (ORR) per investigator assessment using RECIST v1.1 [ Time Frame: Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment up to 1 year after last patient last visit ]
  2. Disease control rate (DRC) per investigator assessment using RECIST v1.1 [ Time Frame: Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment up to 1 year after last patient last visit ]
  3. Duration of response (DOR) per investigator assessment using RECIST v1.1 [ Time Frame: Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment up to 1 year after last patient last visit ]
  4. Time to response (TTR) per investigator assessment using RECIST v1.1 [ Time Frame: Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment up to 1 year after last patient last visit ]
  5. Antidrug antibodies (ADA) [ Time Frame: Cycle1 Day1, Cycle2 Day1, Cycle4 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1 (each cycle is 3 weeks) and through end of treatment, an average of 1 year ]
  6. Cmax [ Time Frame: Cycle1 Day1, Cycle1 Day2, Cycle1 Day8, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle5 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1(each cycle is 3 weeks) and through treatment end, an average of 1 year ]
  7. Area under the curve (AUC) [ Time Frame: Cycle1 Day1, Cycle1 Day2, Cycle1 Day8, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle5 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1(each cycle is 3 weeks) and through treatment end, an average of 1 year ]
  8. Ctrough [ Time Frame: Cycle1 Day1, Cycle1 Day2, Cycle1 Day8, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle5 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1(each cycle is 3 weeks) and through treatment end, an average of 1 year ]
  9. Patient reported outcome (PRO) [ Time Frame: Baseline and every visit until end of treatment and 2 times after disease progression, an average of 1 year ]


Information from the National Library of Medicine

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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

Key inclusion criteria:

  • Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
  • Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.
  • Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
  • At least 1 measurable lesion by RECIST 1.1

Key exclusion criteria:

  • Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
  • Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
  • Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing.
  • Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.
  • Subject with suspected or proven immune-compromised state or infections.
  • Subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.

Other protocol-defined inclusion/exclusion criteria may apply.


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): NCT03631199


Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03631199     History of Changes
Other Study ID Numbers: CACZ885U2301
2018-001547-32 ( EudraCT Number )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
CANOPY-1
ACZ885
canakinumab
pembrolizumab
carboplatin
cisplatin
paclitaxel
nab-paclitaxel
pemetrexed
NSCLC
non-small cell lung cancer
non small cell lung cancer
squamous
non-squamous
hsCRP
IL-1β
PD-L1
CANOPY
platinum-based doublet chemotherapy
first line therapy
locally advanced
metastatic

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Pembrolizumab
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Immunologic Factors
Physiological Effects of Drugs