Clinical Trials /

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

NCT03647488

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CINC280D2201
  • SECONDARY ID: 2018-001420-19
  • NCT ID: NCT03647488

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
capmatinibINC280Capmatinib plus spartalizumab
spartalizumabPDR001Capmatinib plus spartalizumab
docetaxelDocetaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Capmatinib plus spartalizumabExperimentalCombination arm
  • capmatinib
  • spartalizumab
DocetaxelActive ComparatorComparator arm
  • docetaxel

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:to assess safety and tolerability of capmatinib and spartalizumab combination

Secondary Outcome Measures

Measure:Objective response rate
Time Frame:after 60 OS events are observed, approximately 18 months
Safety Issue:
Description:Objective response rate is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR).
Measure:Disease control rate
Time Frame:after 60 OS events are observed, approximately 18 months
Safety Issue:
Description:Disease control rate is defined as the proportion of subjects with best overall response of complete response or partial response or stable disease.
Measure:Progression free survival
Time Frame:after 60 OS events are observed, approximately 18 months
Safety Issue:
Description: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.
Measure:Time to response
Time Frame:after 60 OS events are observed, approximately 18 months
Safety Issue:
Description: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).
Measure:Duration of response
Time Frame:after 60 OS events are observed, approximately 18 months
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description:The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Measure: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
Safety Issue:
Description:The AUC calculated to the end of a dosing interval (tau) at steady-state
Measure: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
Safety Issue:
Description:The maximum (peak) observed plasma serum concentration after single dose administration.
Measure: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
Safety Issue:
Description:Ctrough is defined as the minimum (peak) observed plasma serum concentration (mass x volume-1)
Measure: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
Safety Issue:
Description:Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
Measure: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
Safety Issue:
Description:The elimination half-life associated with the terminal slope (lz) of a semi logarithmic concentration-time curve (time).
Measure: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
Safety Issue:
Description:Antidrug antibodies (ADA) prevalence at baseline and ADA incidence on treatment

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • 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

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