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.
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
Drug | Synonyms | Arms |
---|
capmatinib | INC280 | Capmatinib plus spartalizumab |
spartalizumab | PDR001 | Capmatinib plus spartalizumab |
docetaxel | | Docetaxel |
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
Name | Type | Description | Interventions |
---|
Capmatinib plus spartalizumab | Experimental | Combination arm | |
Docetaxel | Active Comparator | Comparator arm | |
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: | Completed |
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
Last Updated
April 1, 2021