Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03647488
Recruitment Status : Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE December 26, 2018
Estimated Primary Completion Date November 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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)
  • 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
  • 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.
  • 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)
  • 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)
  • 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).
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: capmatinib
    Tablets, given orally
    Other Name: INC280
  • Drug: spartalizumab
    Concentrate for solution for infusion, intravenous use
    Other Name: PDR001
  • Drug: docetaxel
    Concentrate for solution for infusion, intravenous use
Study Arms  ICMJE
  • Experimental: Capmatinib plus spartalizumab
    Combination arm
    Interventions:
    • Drug: capmatinib
    • Drug: spartalizumab
  • Active Comparator: Docetaxel
    Comparator arm
    Intervention: Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 25, 2020)
18
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
105
Estimated Study Completion Date  ICMJE November 20, 2020
Estimated Primary Completion Date November 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Israel,   Spain,   United States
Removed Location Countries Greece,   Japan,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03647488
Other Study ID Numbers  ICMJE CINC280D2201
2018-001420-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP