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Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03647488
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This is a clinical research study and the purpose of the study is to learn whether the combination of the drugs capmatinib plus spartalizumab helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients with NSCLC.

Capmatinib is an oral drug that is called a "targeted" medicine: this means it targets particular processes, which may not be working properly in the cancer cells in your body (called dysregulation) and which may be causing your disease.

Spartalizumab is an antibody (a kind of protein that binds to a specific "target" protein). By blocking its "target" protein, called PD-1, spartalizumab may increase the activity of a certain type of cells in your immune system, which may reduce the growth of your tumor.

Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung cancer. This standard, anti-cancer medicine is a cytotoxic chemotherapy that is being compared with capmatinib and spartalizumab.

The reason for this study is to find out which of these two treatments (combination of capmatinib plus spartalizumab OR docetaxel alone) helps to control lung cancer better.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: capmatinib Drug: spartalizumab Drug: docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative Advanced/Metastatic Non-small Cell Lung Cancer
Actual Study Start Date : December 26, 2018
Estimated Primary Completion Date : December 22, 2021
Estimated Study Completion Date : December 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Capmatinib plus spartalizumab
Combination arm
Drug: capmatinib
Tablets, given orally
Other Name: INC280

Drug: spartalizumab
Concentrate for solution for infusion, intravenous use
Other Name: PDR001

Active Comparator: Docetaxel
Comparator arm
Drug: docetaxel
Concentrate for solution for infusion, intravenous use




Primary Outcome Measures :
  1. Run in part: Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: after all participants have completed 24 weeks of follow-up, approximately 11 months ]
    to assess safety and tolerability of capmatinib and spartalizumab combination

  2. Randomized part: Overall survival (OS) [ Time Frame: after 60 events have been observed, approximately 18 months ]
    Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause.


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: after 60 OS events are observed, approximately 18 months ]
    Objective response rate is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR).

  2. Disease control rate [ Time Frame: after 60 OS events are observed, approximately 18 months ]
    Disease control rate is defined as the proportion of subjects with best overall response of complete response or partial response or stable disease.

  3. Progression free survival [ Time Frame: after 60 OS events are observed, approximately 18 months ]
    Progression free survival is defined as the time from the date of randomization (randomized part) or start of treatment (run-in part) to the date of the first documented radiological progression or death due to any cause.

  4. Time to response [ Time Frame: after 60 OS events are observed, approximately 18 months ]
    Time to response (TTR) is defined as the time from the date of randomization (randomized part) or start of treatment (run-in part) to the first documented response of either complete response or partial response, which must be subsequently confirmed (although date of initial response is used, not date of confirmation).

  5. Duration of response [ Time Frame: after 60 OS events are observed, approximately 18 months ]
    Duration of response only applies to subjects for whom best overall response is complete response or partial response. DOR is defined as the time between the date of first documented response (CR or PR) and the date of first documented progression or death due to underlying cancer. If progression or death due to underlying cancer has not occurred, then the subject is censored at the date of last adequate tumor assessment.

  6. AUClast [ Time Frame: 1, 2, 3, 4, 6, 8, 10, 12 months and then every 6 months until treatment discontinuation, and then 3 and 5 months after treatment discontinuation ]
    The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)

  7. AUCtau [ Time Frame: 1, 2, 3, 4, 6, 8, 10, 12 months and then every 6 months until treatment discontinuation, and then 3 and 5 months after treatment discontinuation ]
    The AUC calculated to the end of a dosing interval (tau) at steady-state

  8. Cmax [ Time Frame: 1, 2, 3, 4, 6, 8, 10, 12 months and then every 6 months until treatment discontinuation, and then 3 and 5 months after treatment discontinuation ]
    The maximum (peak) observed plasma serum concentration after single dose administration.

  9. Ctrough [ Time Frame: 1, 2, 3, 4, 6, 8, 10, 12 months and then every 6 months until treatment discontinuation, and then 3 and 5 months after treatment discontinuation ]
    Ctrough is defined as the minimum (peak) observed plasma serum concentration (mass x volume-1)

  10. Tmax [ Time Frame: 1, 2, 3, 4, 6, 8, 10, 12 months and then every 6 months until treatment discontinuation, and then 3 and 5 months after treatment discontinuation ]
    Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)

  11. T 1/2 [ Time Frame: 1, 2, 3, 4, 6, 8, 10, 12 months and then every 6 months until treatment discontinuation, and then 3 and 5 months after treatment discontinuation ]
    The elimination half-life associated with the terminal slope (lz) of a semi logarithmic concentration-time curve (time).

  12. Immunogenicity, characterized by tabulating anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment [ Time Frame: 1, 2, 3, 4, 6, 8, 10, 12 months and then every 6 months until treatment discontinuation, and then 3 and 5 months after treatment discontinuation ]
    Antidrug antibodies (ADA) prevalence at baseline and ADA incidence on treatment



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

Inclusion Criteria:

  • Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type, ALK rearrangement negative, non-small cell lung cancer
  • Subject has demonstrated progression following one prior platinum doublet and one prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)
  • Subjects must be candidates for single agent docetaxel
  • Subjects must have at least one lesion evaluable by RECIST 1.1

Exclusion Criteria:

  • Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting therapy
  • Any untreated central nervous system (CNS) lesion
  • Use of any live vaccines against infectious diseases within 12 weeks of initiation of study treatment.

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): NCT03647488


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact    479-587-1700      
Principal Investigator: Eric S Schaefer         
United States, Florida
H Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Tara Ackerman    888-663-3488    Tara.Ackerman@Moffitt.org   
Principal Investigator: Jhanelle Gray         
United States, North Carolina
Levine Cancer Institute SC Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Sandy Pollock       sandy.pollock@atriumhealth.org   
Principal Investigator: Edward Kim         
Belgium
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
France
Novartis Investigative Site Recruiting
Grenoble, France, 38043
Novartis Investigative Site Recruiting
LILLE Cédex, France, 59037
Germany
Novartis Investigative Site Recruiting
Koeln, Germany, 50937
Israel
Novartis Investigative Site Recruiting
Tel Aviv, Israel, 6423906
Japan
Novartis Investigative Site Recruiting
Sunto Gun, Shizuoka, Japan, 411 8777
Netherlands
Novartis Investigative Site Recruiting
Nijmegen, Netherland, Netherlands, 6525 GA
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03647488     History of Changes
Other Study ID Numbers: CINC280D2201
2018-001420-19 ( EudraCT Number )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 ):
Non-small-cell lung carcinoma
Non-small-cell lung cancer
NSCLC
epidermal growth factor receptor wild type
EGFRwt
Anaplastic lymphoma kinase negative
ALK-
INC280
capmatinib and spartalizumab
combination therapy
docetaxel

Additional relevant MeSH terms:
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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
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action