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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002660-27 | EudraCT Number |
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Sponsor decision to terminate due to the lack of tolerability observed in patients treated with capmatinib and pembrolizumab in the combination arm as compared to patients treated with pembrolizumab alone in the pembrolizumab single agent arm
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The purpose was to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.
This was a randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of capmatinib plus pembrolizumab in comparison to pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand-1 (PD-L1) expression ≥ 50%, mesenchymal epithelial transition (MET) unselected, epidermal growth factor receptor (EGFR) wild type and anaplastic lymphoma kinase (ALK) negative.
All eligible subjects were randomized to one of the treatment arms in a 2:1 (capmatinib plus pembrolizumab: pembrolizumab alone) ratio. Participants in both treatment arms were to receive up to 35 cycles (approximately 24 months) of study treatment. The study enrollment was halted on 21-Jan-2021 per sponsor's decision. The enrollment halt decision was based on lack of tolerability observed in the capmatinib plus pembrolizumab arm.
Immediately following the enrollment halt, the below procedural changes were performed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capmatinib 400mg BID + pembrolizumab 200mg Q3W | Experimental | Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W) |
|
| Pembrolizumab 200mg Q3W | Active Comparator | Pembrolizumab 200 mg intravenously every 3 weeks (Q3W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capmatinib | Drug | INC280 tablets were administered orally at 400 mg on a continuous twice daily (BID) dosing schedule, from Day 1 until Day 21 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by Investigator Assessment as Per RECIST 1.1 | PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment, the start of a subsequent anti-neoplastic therapy (if any) or the date of sponsor's decision to discontinue capmatinib (applicable only to subjects on the combination arm). Due to the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm, PFS was censored on the 21-Jan-2021 or the last adequate tumor assessment prior to that date for the capmatinib plus pembrolizumab arm. PFS was analyzed using Kaplan-Meier estimates. | Up to 1.3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1 | Tumor response was based on local investigator assessment as RECIST v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). For the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Wollongong | New South Wales | 2500 | Australia | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 28 days prior to the first dose of study treatment. After screening, the treatment period started on Cycle 1 Day 1.
Participants took part in 36 investigative sites in 16 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capmatinib 400mg BID + Pembrolizumab 200mg Q3W | Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W) |
| FG001 | Pembrolizumab 200mg Q3W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2021 | Jan 15, 2024 |
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|
| Pembrolizumab | Biological | Pembrolizumab was administered by intravenous infusion at 200 mg once every 3 weeks (Q3W). |
|
|
| Up to 1.3 years |
| Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1 | Tumor response was based on local investigator assessment per RECIST v1.1. DCR is defined as the percentage of participants with a BOR of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and non-CR/non-progressive disease (for subjects without target lesions). For the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression). | Up to 1.3 years |
| Time to Response (TTR) by Investigator Assessment as Per RECIST 1.1 | TTR is defined as the time from the date of randomization to the first documented response of either complete response or partial response, which must be subsequently confirmed (although initial date of response is used, not date of confirmation). TTR was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan. | Up to 1.3 years |
| Duration of Response (DOR) by Investigator Assessment as Per RECIST 1.1 | DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment of overall lesion response according to RECIST v1.1. DOR is defined as the time from the date of first documented response (confirmed CR or confirmed PR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any. DOR was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan. | Up to 1.3 years |
| Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. The requirement for survival follow-up period was removed following the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm and the implementation of Protocol Amendment 03. OS was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan. | Up to 2.1 years |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. | From first dose of study treatment to 30 days after last dose, up to 2.1 years |
| Maximum Observed Plasma Concentration (Cmax) of Capmatinib | Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose. | pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days. |
| Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib | PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations. | pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days. |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib | PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation. | pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days. |
| Trough Serum Concentration (Ctrough) of Pembrolizumab | PK parameters were calculated based on pembrolizumab serum concentrations by using non-compartmental methods. Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters. | pre-dose on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1 and Cycle 12 Day 1. The duration of one cycle was 21 days. |
| Number of Participants With Anti-pembrolizumab Antibodies | Immunogenicity (IG) was evaluated in serum samples. The assay to quantify and assess the IG was a validated homogeneous enzyme-linked immunosorbent assay (ELISA).
| Baseline (pre-dose), up to 8 months |
| North Adelaide |
| South Australia |
| 5006 |
| Australia |
| Novartis Investigative Site | Shepparton | Victoria | 3630 | Australia |
| Novartis Investigative Site | Yvoir | 5530 | Belgium |
| Novartis Investigative Site | Québec | Quebec | GIV 4G5 | Canada |
| Novartis Investigative Site | Ostrava Vitkovice | 703 84 | Czechia |
| Novartis Investigative Site | Lille | 59000 | France |
| Novartis Investigative Site | Strasbourg | 67091 | France |
| Novartis Investigative Site | Toulouse | 31400 | France |
| Novartis Investigative Site | Berlin | 14165 | Germany |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Athens | 11526 | Greece |
| Novartis Investigative Site | Thessaloniki | 57001 | Greece |
| Novartis Investigative Site | Shatin New Territories | Hong Kong | Hong Kong |
| Novartis Investigative Site | Mumbai | Maharashtra | 401107 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700160 | India |
| Novartis Investigative Site | Delhi | 110 085 | India |
| Novartis Investigative Site | Ancona | AN | 60126 | Italy |
| Novartis Investigative Site | Aviano | PN | 33081 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466 8560 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236 0051 | Japan |
| Novartis Investigative Site | Kuching | Sarawak | 93586 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Amersfoort | 3813 TZ | Netherlands |
| Novartis Investigative Site | Breda | 4819 EV | Netherlands |
| Novartis Investigative Site | Zwolle | 8025 AB | Netherlands |
| Novartis Investigative Site | Badalona | Catalonia | 08916 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46010 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Changhua | 50006 | Taiwan |
| Novartis Investigative Site | Taichung | 40705 | Taiwan |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
| Entered Post-treatment Follow-up | Post-treatment disease progression follow-up and survival follow-up started on day 31 after last dose of study treatment. This was applicable until the implementation of Protocol Amendment 03. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capmatinib 400mg BID + Pembrolizumab 200mg Q3W | Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W) |
| BG001 | Pembrolizumab 200mg Q3W | Pembrolizumab 200 mg intravenously every 3 weeks (Q3W) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by Investigator Assessment as Per RECIST 1.1 | PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment, the start of a subsequent anti-neoplastic therapy (if any) or the date of sponsor's decision to discontinue capmatinib (applicable only to subjects on the combination arm). Due to the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm, PFS was censored on the 21-Jan-2021 or the last adequate tumor assessment prior to that date for the capmatinib plus pembrolizumab arm. PFS was analyzed using Kaplan-Meier estimates. | All patients to whom study treatment had been assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 1.3 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1 | Tumor response was based on local investigator assessment as RECIST v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). For the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | All patients to whom study treatment had been assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1.3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1 | Tumor response was based on local investigator assessment per RECIST v1.1. DCR is defined as the percentage of participants with a BOR of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and non-CR/non-progressive disease (for subjects without target lesions). For the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression). | All patients to whom study treatment had been assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) by Investigator Assessment as Per RECIST 1.1 | TTR is defined as the time from the date of randomization to the first documented response of either complete response or partial response, which must be subsequently confirmed (although initial date of response is used, not date of confirmation). TTR was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan. | All patients to whom study treatment had been assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 1.3 years |
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| Secondary | Duration of Response (DOR) by Investigator Assessment as Per RECIST 1.1 | DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment of overall lesion response according to RECIST v1.1. DOR is defined as the time from the date of first documented response (confirmed CR or confirmed PR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any. DOR was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan. | All patients to whom study treatment had been assigned by randomization and for whom best overall response was CR or PR as per RECIST v1.1 based on local investigator assessment. | Posted | Median | 95% Confidence Interval | months | Up to 1.3 years |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. The requirement for survival follow-up period was removed following the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm and the implementation of Protocol Amendment 03. OS was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan. | All patients to whom study treatment had been assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Up to 2.1 years |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. | All patients to whom study treatment had been assigned by randomization. Patients are analyzed according to the treatment they were randomized to. | Posted | Count of Participants | Participants | From first dose of study treatment to 30 days after last dose, up to 2.1 years |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Capmatinib | Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose. | Patients in the capmatinib pharmacokinetic analysis set (INC-PAS) with an available value for the outcome measure. INC-PAS consists of all patients who provided at least one blood sample with measurable capmatinib PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days. |
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib | PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations. | Patients in the capmatinib pharmacokinetic analysis set (INC-PAS) with an available value for the outcome measure. INC-PAS consists of all patients who provided at least one blood sample with measurable capmatinib PK data. | Posted | Median | Full Range | hours | pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days. |
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| |||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib | PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation. | Patients in the capmatinib pharmacokinetic analysis set (INC-PAS) with an available value for the outcome measure. INC-PAS consists of all patients who provided at least one blood sample with measurable capmatinib PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days. |
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| Secondary | Trough Serum Concentration (Ctrough) of Pembrolizumab | PK parameters were calculated based on pembrolizumab serum concentrations by using non-compartmental methods. Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters. | Patients in the pembrolizumab pharmacokinetic analysis set (Pembro-PAS) with an available value for the outcome measure at each timepoint. Pembro-PAS consists of all patients who provided at least one blood sample with measurable pembrolizumab PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | pre-dose on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1 and Cycle 12 Day 1. The duration of one cycle was 21 days. |
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| Secondary | Number of Participants With Anti-pembrolizumab Antibodies | Immunogenicity (IG) was evaluated in serum samples. The assay to quantify and assess the IG was a validated homogeneous enzyme-linked immunosorbent assay (ELISA).
| All patients to whom study treatment had been assigned by randomization and who had a determinant baseline IG sample and at least one determinant post-baseline IG sample. A determinant sample is neither ADA-inconclusive nor unevaluable. | Posted | Count of Participants | Participants | Baseline (pre-dose), up to 8 months |
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| Post-Hoc | All-Collected Deaths | On-treatment deaths were collected from start of treatment to 30 days after last dose. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03). All deaths refer to the sum of on-treatment deaths plus post-treatment survival follow-up deaths. | All patients to whom study treatment had been assigned by randomization. Patients are analyzed according to the treatment they were randomized to. | Posted | Number | participants | On-treatment: Up to 2.1 years after start of treatment. Post-treatment survival follow-up: Up to 1.3 years after start of treatment. |
|
|
Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs.
Patients were analyzed according to the treatment they actually received. Deaths in the post-treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capmatinib + Pembrolizumab - On-treatment | Capmatinib 400 mg BID in combination with pembrolizumab 200 mg Q3W. AEs collected during on-treatment period (up to 30 days after last dose). | 8 | 51 | 26 | 51 | 41 | 51 |
| EG001 | Pembrolizumab After Combination Treatment - On-treatment | Pembrolizumab single agent 200 mg Q3W after discontinuing capmatinib. AEs collected during on-treatment period (up to 30 days after last dose). | 2 | 51 | 9 | 51 | 29 | 51 |
| EG002 | Pembrolizumab - On-treatment | Pembrolizumab single agent 200 mg Q3W from study start. AEs collected during on-treatment period (up to 30 days after last dose). | 3 | 25 | 13 | 25 | 24 | 25 |
| EG003 | Capmatinib + Pembrolizumab - Post-treatment Survival Follow-up | Capmatinib 400 mg BID in combination with pembrolizumab 200 mg Q3W. Deaths collected in the post-treatment follow-up period (starting from day 31 after last dose). No AEs were collected during this period. | 6 | 38 | 0 | 0 | 0 | 0 |
| EG004 | Pembrolizumab - Post-treatment Survival Follow-up | Pembrolizumab single agent 200 mg Q3W from study start. Deaths collected in the post-treatment follow-up period (starting from day 31 after last dose). No AEs were collected during this period. | 5 | 20 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Meningitis listeria | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Myelitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| SARS-CoV-2 test negative | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2021 | Jan 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613976 | capmatinib |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Unknown |
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