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The purpose of the study was to learn whether the study treatment (capmatinib), which already shows efficacy and safety in non-Chinese patients, could help Chinese patients with controlling their lung cancer in a safe way. Participants had a type of lung cancer called non-small cell lung lancer (NSCLC), with a specific alteration in a part of their DNA (called mutation) of the MET gene, within a specific part of this gene called exon 14.
Participants who had advanced (or metastatic) non-small cell lung cancer with specific mutations in the MET gene but without mutations in the EGFR or ALK genes, who were aged 18 years or older were enrolled in this study.
The study drug, capmatinib (also known as INC280), is an oral drug that is called a 'targeted' medicine, which means it targets particular processes that may not be working properly in cancer cells (called dysregulation). The dysregulation of the MET signaling in cancer cells of patients with NSCLC is believed to make the cancer worse. Capmatinib has been shown to selectively block the effects of the MET gene and therefore may help in keeping the disease under control, stopping cancer cells from growing.
This was an open-label, multicenter two-cohort phase II study. Chinese adult participants with EGFR wild-type (wt) (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative, advanced (stage IIIB, IIIC or IV) NSCLC disease harboring MET exon 14-skipping (METΔex14) mutations as determined by a Novartis central molecular laboratory were treated in this study. Cohort 1 included treatment naive participants and Cohort 2 participants who failed one or two prior lines of therapy in the advanced stage (stage IIIB, IIIC or IV). Each participant received 400 mg capmatinib tablet twice daily (BID) until either the disease worsened or there were other reasons to discontinue the drug.
After treatment discontinuation, participants were followed for safety up to 30 days after the last dose of study drug. In addition to the 30-day safety follow-up, participants who discontinued treatment without documented progressive disease (PD) continued efficacy assessments and patient-reported outcomes (PROs) collection during the post-treatment follow-up until documented progression.
After the post-treatment follow-up phase, the participant's survival status was collected as part of the survival follow-up phase.
The primary endpoint was the overall response rate (ORR) by cohort as per the blinded independent review committee (BIRC) review. ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST 1.1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Treatment Naive participants |
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| Cohort 2 | Experimental | Participants received one or two prior lines of treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capmatinib | Drug | 400 mg of capmatinib tablets, administered orally twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Per RECIST v1.1 by BIRC Assessment | Tumor response was assessed by a blinded independent review committee (BIRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). 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. The primary efficacy endpoint ORR was estimated and the exact 95% confidence interval (CI) was provided by cohort. | Up to approximately 125 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration Of Response (DOR) Per RECIST v1.1 by BIRC Assessment | DOR only applies to patients whose best overall response is complete response (CR) or partial response (PR) based on BIRC assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. |
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Key Inclusion Criteria:
Chinese adult ≥ 18 years old at the time of informed consent
Histologically confirmed stage IIIB, IIIC or IV NSCLC at the time of study entry, not amenable to curative surgery or radiation or multi-modality therapy (according to staging definition in CSCO guidelines for primary lung cancer, 2019).
Histologically or cytologically confirmed diagnosis of NSCLC that is:
Cohort 1: Treatment naive participants with MET mutations, or Cohort 2: Pre-treated participants with MET mutations
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Xiamen | Fujian | 361001 | China | ||
| Novartis Investigative Site |
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| Label | URL |
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| A Plain Language Trial Summary is available on www.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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Participants underwent molecular pre-screening to confirm eligibility based on protocol-defined criteria. Upon confirmation, all screening evaluations were required to be completed within 28 days prior to administration of the first treatment dose. Following successful screening, the treatment period commenced on Cycle 1 Day 1.
Participants took part in 17 investigative sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Treatment-naïve participants who received capmatinib 400 mg orally twice daily |
| FG001 | Cohort 2 | Participants who had failed one or two prior lines of therapy and received capmatinib 400 mg orally twice daily |
| 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 | Jul 7, 2022 | Feb 19, 2026 |
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| Up to approximately 189 weeks (median 33.6 weeks) |
| Overall Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment | Tumor response was assessed by the investigator based on RECIST v1.1. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). 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. | Up to approximately 189 weeks (median 33.6 weeks) |
| Duration Of Response (DOR) Per RECIST v1.1 by Investigator Assessment | DOR only applies to patients whose best overall response is complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. | Up to approximately 189 weeks (median 33.6 weeks) |
| Time To Response (TTR) Per RECIST v1.1 by BIRC and Investigator Assessment | TTR is defined as the time from the start date of study drug to the first documented response of either CR or PR, which must be subsequently confirmed. If a patient did not have an event, TTR was censored as defined in the statistical analysis plan. Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. TTR was estimated using the Kaplan-Meier method. | Up to approximately 189 weeks (median 33.6 weeks) |
| Disease Control Rate (DCR) Per RECIST v1.1 by BIRC and Investigator Assessment | DCR is the percentage of patients with a best overall response of CR, PR or stable disease (SD), based on BIRC review and local investigator assessment per RECIST v1.1. | Up to approximately 189 weeks (median 33.6 weeks) |
| Progression-Free Survival (PFS) Per RECIST v1.1 by BIRC and Investigator Assessment | PFS is defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) or death due to any cause. If a patient did not have an event, PFS was censored as defined in the statistical analysis plan. Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. PFS was estimated using the Kaplan-Meier method. | Up to approximately 193 weeks (median 37.6 weeks) |
| Overall Survival (OS) | OS is defined as the time from the start date of study drug to the date of death due to any cause. If a patient did not have an event, OS was censored as defined in the statistical analysis plan. OS was estimated using the Kaplan-Meier method. | Up to approximately 193 weeks (median 37.6 weeks) |
| Overall Intracranial Response Rate (OIRR) Per RANO-BM Criteria by BIRC Assessment | OIRR was calculated based on response assessments in the brain for participants having measurable or non-measurable brain metastases at baseline. OIRR is defined as the percentage of participants with a confirmed best overall intracranial response of CR or PR from the start of treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started) per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria as assessed by BIRC review. | Up to approximately 189 weeks (median 33.6 weeks) |
| Intracranial Disease Control Rate (IDCR) Per RANO-BM Criteria by BIRC Assessment | IDCR is defined as the percentage of participants with a confirmed best overall intracranial response of CR or PR or SD (or non-CR/non-PD) per RANO-BM criteria as assessed by BIRC review. | Up to approximately 189 weeks (median 33.6 weeks) |
| Time To Intracranial Response (TTIR) Per RANO-BM Criteria by BIRC Assessment | TTIR is defined as the time from the start date of study drug to the date of the first documented intracranial response of either CR or PR per RANO-BM criteria as assessed by the BIRC review, which must be subsequently confirmed. If a patient did not have an event, TTIR was censored as defined in the statistical analysis plan. TTIR was estimated using the Kaplan-Meier method. | Up to approximately 189 weeks (median 33.6 weeks) |
| Duration Of Intracranial Response (DOIR) Per RANO-BM Criteria by BIRC Assessment | DOIR only applies to participants whose confirmed best overall intracranial response is CR or PR per RANO-BM criteria as assessed by the BIRC review. DOIR is defined as the time from the date of first documented intracranial response of either CR or PR to the date of the first documented intracranial progression per RANO-BM criteria as assessed by BIRC review or date of death due to any cause. If a patient did not have an event, DOIR was censored as defined in the statistical analysis plan. DOIR was estimated using the Kaplan-Meier method. | Up to approximately 189 weeks (median 33.6 weeks) |
| ORR Per RECIST v1.1 by BIRC and Investigator Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between Mesenchymal Epithelial Transition (MET) mutation status in baseline circulating tumor DNA (ctDNA) and capmatinib efficacy. These blood samples were tested for MET exon 14 (METex14) skipping mutations and classified as mutant or non-mutant. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| DOR Per RECIST v1.1 by BIRC Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between MET mutation status in baseline ctDNA and capmatinib efficacy. These blood samples were tested for METex14 skipping mutations and classified as mutant or non-mutant. DOR only applies to patients whose best overall response is CR or PR based on BIRC assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| DOR Per RECIST v1.1 by Investigator Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between MET mutation status in baseline ctDNA and capmatinib efficacy. These blood samples were tested for METex14 skipping mutations and classified as mutant or non-mutant. DOR only applies to patients whose best overall response is CR or PR based on investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| PFS Per RECIST v1.1 by BIRC and Investigator Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between MET mutation status in baseline ctDNA and capmatinib efficacy. These blood samples were tested for METex14 skipping mutations and classified as mutant or non-mutant. PFS is defined as the time from the start date of study drug to the date of the first radiologically documented PD or death due to any cause. If a patient did not have an event, PFS was censored as defined in the statistical analysis plan. Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. PFS was estimated using the Kaplan-Meier method. | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| Capmatinib Plasma Concentrations at Steady-state | Plasma capmatinib concentrations at steady state were quantified using a validated liquid chromatography tandem-mass spectrometry assay. Concentrations below the lower limit of quantification were treated as zero in the calculations. Pre-dose concentrations correspond to Ctrough, defined as the lowest plasma drug concentration observed immediately before the next dose. | Cycle 2 Day 1 (C2D1): Pre-dose, 1 hour (±0.5 hours) and 4 hours (±1 hour). Cycle 3 Day 1 (C3D1): Pre-dose. Each cycle duration is 21 days. |
| Number of Participants With AEs and SAEs During the On-treatment Period | Number of participants with AEs (any adverse events regardless of seriousness) and serious adverse events (SAEs), including changes in physical exams, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For CTCAE v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. The on-treatment period is defined from the day of first administration of study drug up to 30 days after the date of the last actual administration of study drug. | Up to approximately 193 weeks (median 37.6 weeks) |
| Change From Baseline in EORTC QLQ-C30: Global Health Status/Quality of Life (QoL) Scale | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items and is composed of both multi-item scales and single-item measures. These include 1 global health status/quality of life (QoL) scale, 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scales and single-item measures are scored from 0 to 100. This record summarizes the values of the global health status/QoL scale (0 to 100), where higher scores indicate better health/QoL. Therefore, a positive change from baseline is favorable. | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
| Change From Baseline in EORTC QLQ-LC13: Dyspnea Scale | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module 13 (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The 13 items of the LC13 include 1 multi-item scale (dyspnea) and 9 single items (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts). Each item uses a 4-point Likert scale (1=not at all, 4=very much). Scores for both the dyspnea scale and single items are transformed to a 0-100 scale. This record summarizes the values of the dyspnea scale (0 to 100), where higher scores indicate greater symptom burden. Therefore, a negative change from baseline is a favorable outcome. | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
| Change From Baseline in EQ-5D-5L: EQ VAS | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a standardized, generic instrument to measure health-related quality of life (HRQoL). It consists of two components: a descriptive system and a visual analogue scale. The descriptive system includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each rated on five levels of severity (1=no problems, 5=extreme problems). The EuroQol visual analogue scale (EQ VAS) is a 0-100 scale for self-rated overall health, where 0 represents the worst imaginable health and 100 the best imaginable health. This record summarizes the values of the EQ VAS (0 to 100), where higher scores indicate better health. Therefore, a positive change from baseline is favorable. | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
| Change From Baseline in NCCN FACT-FBrSI: Total Composite Score | The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy - Brain Symptom Index (NCCN FACT-FBrSI) was used to assess changes in symptoms potentially associated with brain metastases in this study. The NCCN FACT-FBrSI contains 24 items with a 7-day recall period and includes the following subscales: Disease-related symptoms - physical (12 items), Disease-related symptoms - emotional (5 items), Treatment side effects (5 items) and Function/well-being (2 items). Each item uses a 5-point Likert-type scale (0 = Not at all; 4 = Very much). Negatively worded items are reverse scored so that higher scores consistently indicate better symptom status and well-being. The total composite score is the sum of all 24 items and ranges from 0 to 96, with higher scores indicating better symptom status and well-being. An increase in the total composite score from baseline indicates a favorable outcome, while a decrease indicates an unfavorable outcome. | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
| Foshan |
| Guangdong |
| 528000 |
| China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510080 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510515 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 524000 | China |
| Novartis Investigative Site | Harbin | Heilongjiang | 150000 | China |
| Novartis Investigative Site | Zhengzhou | Henan | 450003 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430024 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110001 | China |
| Novartis Investigative Site | Jinan | Shandong | 250117 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200030 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Kunming | Yunnan | 650106 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310022 | China |
| Novartis Investigative Site | Beijing | 100142 | China |
| Novartis Investigative Site | Shanghai | 200030 | China |
| Novartis Investigative Site | Tianjin | 300052 | China |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Treatment-naïve participants who received capmatinib 400 mg orally twice daily |
| BG001 | Cohort 2 | Participants who had failed one or two prior lines of therapy and received capmatinib 400 mg orally twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Overall Response Rate (ORR) Per RECIST v1.1 by BIRC Assessment | Tumor response was assessed by a blinded independent review committee (BIRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). 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. The primary efficacy endpoint ORR was estimated and the exact 95% confidence interval (CI) was provided by cohort. | Full Analysis Set (FAS) defined as all patients who received at least one dose of capmatinib. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 125 weeks |
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| Secondary | Duration Of Response (DOR) Per RECIST v1.1 by BIRC Assessment | DOR only applies to patients whose best overall response is complete response (CR) or partial response (PR) based on BIRC assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. | Participants in the FAS with a best overall response of CR or PR per RECIST v1.1 by BIRC assessment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Overall Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment | Tumor response was assessed by the investigator based on RECIST v1.1. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). 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. | Full Analysis Set (FAS) defined as all patients who received at least one dose of capmatinib. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Duration Of Response (DOR) Per RECIST v1.1 by Investigator Assessment | DOR only applies to patients whose best overall response is complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. | Participants in the FAS with a best overall response of CR or PR per RECIST v1.1 by investigator assessment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Time To Response (TTR) Per RECIST v1.1 by BIRC and Investigator Assessment | TTR is defined as the time from the start date of study drug to the first documented response of either CR or PR, which must be subsequently confirmed. If a patient did not have an event, TTR was censored as defined in the statistical analysis plan. Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. TTR was estimated using the Kaplan-Meier method. | Full Analysis Set (FAS) defined as all patients who received at least one dose of capmatinib. | Posted | Median | 95% Confidence Interval | months | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Disease Control Rate (DCR) Per RECIST v1.1 by BIRC and Investigator Assessment | DCR is the percentage of patients with a best overall response of CR, PR or stable disease (SD), based on BIRC review and local investigator assessment per RECIST v1.1. | Full Analysis Set (FAS) defined as all patients who received at least one dose of capmatinib. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Progression-Free Survival (PFS) Per RECIST v1.1 by BIRC and Investigator Assessment | PFS is defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) or death due to any cause. If a patient did not have an event, PFS was censored as defined in the statistical analysis plan. Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. PFS was estimated using the Kaplan-Meier method. | Full Analysis Set (FAS) defined as all patients who received at least one dose of capmatinib. | Posted | Median | 95% Confidence Interval | months | Up to approximately 193 weeks (median 37.6 weeks) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the start date of study drug to the date of death due to any cause. If a patient did not have an event, OS was censored as defined in the statistical analysis plan. OS was estimated using the Kaplan-Meier method. | Full Analysis Set (FAS) defined as all patients who received at least one dose of capmatinib. | Posted | Median | 95% Confidence Interval | months | Up to approximately 193 weeks (median 37.6 weeks) |
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| Secondary | Overall Intracranial Response Rate (OIRR) Per RANO-BM Criteria by BIRC Assessment | OIRR was calculated based on response assessments in the brain for participants having measurable or non-measurable brain metastases at baseline. OIRR is defined as the percentage of participants with a confirmed best overall intracranial response of CR or PR from the start of treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started) per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria as assessed by BIRC review. | Full Analysis Set - Brain Metastases (FAS-BM) defined as all patients in the FAS who had measurable and/or non-measurable brain metastases at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Intracranial Disease Control Rate (IDCR) Per RANO-BM Criteria by BIRC Assessment | IDCR is defined as the percentage of participants with a confirmed best overall intracranial response of CR or PR or SD (or non-CR/non-PD) per RANO-BM criteria as assessed by BIRC review. | Full Analysis Set - Brain Metastases (FAS-BM) defined as all patients in the FAS who had measurable and/or non-measurable brain metastases at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Time To Intracranial Response (TTIR) Per RANO-BM Criteria by BIRC Assessment | TTIR is defined as the time from the start date of study drug to the date of the first documented intracranial response of either CR or PR per RANO-BM criteria as assessed by the BIRC review, which must be subsequently confirmed. If a patient did not have an event, TTIR was censored as defined in the statistical analysis plan. TTIR was estimated using the Kaplan-Meier method. | Full Analysis Set - Brain Metastases (FAS-BM) defined as all patients in the FAS who had measurable and/or non-measurable brain metastases at baseline. | Posted | Median | 95% Confidence Interval | months | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | Duration Of Intracranial Response (DOIR) Per RANO-BM Criteria by BIRC Assessment | DOIR only applies to participants whose confirmed best overall intracranial response is CR or PR per RANO-BM criteria as assessed by the BIRC review. DOIR is defined as the time from the date of first documented intracranial response of either CR or PR to the date of the first documented intracranial progression per RANO-BM criteria as assessed by BIRC review or date of death due to any cause. If a patient did not have an event, DOIR was censored as defined in the statistical analysis plan. DOIR was estimated using the Kaplan-Meier method. | Participants in the FAS-BM whose confirmed best overall intracranial response is CR or PR per RANO-BM criteria as assessed by the BIRC review. | Posted | Median | 95% Confidence Interval | months | Up to approximately 189 weeks (median 33.6 weeks) |
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| Secondary | ORR Per RECIST v1.1 by BIRC and Investigator Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between Mesenchymal Epithelial Transition (MET) mutation status in baseline circulating tumor DNA (ctDNA) and capmatinib efficacy. These blood samples were tested for MET exon 14 (METex14) skipping mutations and classified as mutant or non-mutant. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. | Participants in the FAS with MET mutation status in ctDNA available at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | DOR Per RECIST v1.1 by BIRC Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between MET mutation status in baseline ctDNA and capmatinib efficacy. These blood samples were tested for METex14 skipping mutations and classified as mutant or non-mutant. DOR only applies to patients whose best overall response is CR or PR based on BIRC assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. | Participants in the FAS with a best overall response of CR or PR per RECIST v1.1 by BIRC assessment, and with MET mutation status in ctDNA available at baseline. | Posted | Median | 95% Confidence Interval | months | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | DOR Per RECIST v1.1 by Investigator Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between MET mutation status in baseline ctDNA and capmatinib efficacy. These blood samples were tested for METex14 skipping mutations and classified as mutant or non-mutant. DOR only applies to patients whose best overall response is CR or PR based on investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response of CR or PR to the date of first documented progression or death due to any cause. If a patient did not have an event, DOR was censored as defined in the statistical analysis plan. DOR was estimated using the Kaplan-Meier method. | Participants in the FAS with a best overall response of CR or PR per RECIST v1.1 by investigator assessment, and with MET mutation status in ctDNA available at baseline. | Posted | Median | 95% Confidence Interval | months | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | PFS Per RECIST v1.1 by BIRC and Investigator Assessment for Patients by MET Mutation Status in ctDNA | At Cycle 1 Day 1 (C1D1, pre-dose), blood samples were collected to investigate the association between MET mutation status in baseline ctDNA and capmatinib efficacy. These blood samples were tested for METex14 skipping mutations and classified as mutant or non-mutant. PFS is defined as the time from the start date of study drug to the date of the first radiologically documented PD or death due to any cause. If a patient did not have an event, PFS was censored as defined in the statistical analysis plan. Tumor response was assessed by BIRC and by the investigator based on RECIST v1.1. PFS was estimated using the Kaplan-Meier method. | Participants in the FAS with MET mutation status in ctDNA available at baseline. | Posted | Median | 95% Confidence Interval | months | Baseline, up to approximately 189 weeks (median 33.6 weeks) |
| ||||||||||||||||||||||||||||||
| Secondary | Capmatinib Plasma Concentrations at Steady-state | Plasma capmatinib concentrations at steady state were quantified using a validated liquid chromatography tandem-mass spectrometry assay. Concentrations below the lower limit of quantification were treated as zero in the calculations. Pre-dose concentrations correspond to Ctrough, defined as the lowest plasma drug concentration observed immediately before the next dose. | Patients in the pharmacokinetic analysis set (PAS) with an available value for the outcome measure at each timepoint. PAS includes all participants who received at least one planned dose of capmatinib and provided at least one evaluable pharmacokinetic (PK) concentration. | Posted | Mean | Standard Deviation | ng/mL | Cycle 2 Day 1 (C2D1): Pre-dose, 1 hour (±0.5 hours) and 4 hours (±1 hour). Cycle 3 Day 1 (C3D1): Pre-dose. Each cycle duration is 21 days. |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With AEs and SAEs During the On-treatment Period | Number of participants with AEs (any adverse events regardless of seriousness) and serious adverse events (SAEs), including changes in physical exams, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For CTCAE v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. The on-treatment period is defined from the day of first administration of study drug up to 30 days after the date of the last actual administration of study drug. | Safety set defined as all patients who received at least one dose of capmatinib. | Posted | Count of Participants | Participants | Up to approximately 193 weeks (median 37.6 weeks) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-C30: Global Health Status/Quality of Life (QoL) Scale | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items and is composed of both multi-item scales and single-item measures. These include 1 global health status/quality of life (QoL) scale, 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scales and single-item measures are scored from 0 to 100. This record summarizes the values of the global health status/QoL scale (0 to 100), where higher scores indicate better health/QoL. Therefore, a positive change from baseline is favorable. | Participants in the FAS with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
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| Secondary | Change From Baseline in EORTC QLQ-LC13: Dyspnea Scale | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module 13 (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The 13 items of the LC13 include 1 multi-item scale (dyspnea) and 9 single items (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts). Each item uses a 4-point Likert scale (1=not at all, 4=very much). Scores for both the dyspnea scale and single items are transformed to a 0-100 scale. This record summarizes the values of the dyspnea scale (0 to 100), where higher scores indicate greater symptom burden. Therefore, a negative change from baseline is a favorable outcome. | Participants in the FAS with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EQ-5D-5L: EQ VAS | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a standardized, generic instrument to measure health-related quality of life (HRQoL). It consists of two components: a descriptive system and a visual analogue scale. The descriptive system includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each rated on five levels of severity (1=no problems, 5=extreme problems). The EuroQol visual analogue scale (EQ VAS) is a 0-100 scale for self-rated overall health, where 0 represents the worst imaginable health and 100 the best imaginable health. This record summarizes the values of the EQ VAS (0 to 100), where higher scores indicate better health. Therefore, a positive change from baseline is favorable. | Participants in the FAS with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in NCCN FACT-FBrSI: Total Composite Score | The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy - Brain Symptom Index (NCCN FACT-FBrSI) was used to assess changes in symptoms potentially associated with brain metastases in this study. The NCCN FACT-FBrSI contains 24 items with a 7-day recall period and includes the following subscales: Disease-related symptoms - physical (12 items), Disease-related symptoms - emotional (5 items), Treatment side effects (5 items) and Function/well-being (2 items). Each item uses a 5-point Likert-type scale (0 = Not at all; 4 = Very much). Negatively worded items are reverse scored so that higher scores consistently indicate better symptom status and well-being. The total composite score is the sum of all 24 items and ranges from 0 to 96, with higher scores indicating better symptom status and well-being. An increase in the total composite score from baseline indicates a favorable outcome, while a decrease indicates an unfavorable outcome. | Participants in the FAS with an available value for the outcome measure at baseline and at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before first dose), Cycle 3 Day 1 (Week 7) and then every 6 weeks until Cycle 65 Day 1 (Week 193). Each cycle duration is 21 days. |
| ||||||||||||||||||||||||||||||
| Post-Hoc | All-Collected Deaths | Deaths in the on-treatment period were recorded from the first dose of study treatment through 30 days after the last dose. Deaths in the survival follow-up period were recorded from 31 days after the last dose of study treatment until the end of the study. All deaths refers to the combined total of deaths occurring during the on-treatment period and the survival follow-up period. The exact duration of the on-treatment and survival follow-up periods varies by patient because treatment exposure differs. Consequently, a death occurring on the same study day (e.g., Day 350) may be classified as on-treatment for one patient and as survival follow-up for another who discontinued treatment earlier. | All participants who received at least one dose of capmatinib. | Posted | Number | participants | On-treatment deaths: up to 193 weeks. Survival follow-up deaths: up to 193 weeks. |
|
|
Adverse events: From the first dose of study treatment through 30 days after the last dose, up to approximately 193 weeks. Deaths: From the first dose of study treatment until the end of the study, up to approximately 193 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Treatment-naïve participants who received capmatinib 400 mg orally twice daily | 11 | 15 | 7 | 15 | 14 | 15 |
| EG001 | Cohort 2 | Participants who had failed one or two prior lines of therapy and received capmatinib 400 mg orally twice daily | 11 | 21 | 14 | 21 | 21 | 21 |
| EG002 | All Patients | All patients in the study | 22 | 36 | 21 | 36 | 35 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Peripheral vein thrombosis | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dyschezia | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Malaise | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Nodule | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Oedema | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Pain | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (28.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hyponatraemic encephalopathy | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Organic brain syndrome | Psychiatric disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (28.0) | 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 | Jun 19, 2025 | Feb 16, 2026 | 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 |
Not provided
Not provided
Not provided
| >=65 to <75 years |
|
| >=75 to <85 years |
|
| Male |
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
| Participants |
|
|
| OG003 | Cohort 2 Non-Mutant | Participants in Cohort 2 whose MET mutation status in baseline ctDNA was determined to be non-mutant |
|
|
| Cohort 1 Non-Mutant |
Participants in Cohort 1 whose MET mutation status in baseline ctDNA was determined to be non-mutant |
| OG003 | Cohort 2 Non-Mutant | Participants in Cohort 2 whose MET mutation status in baseline ctDNA was determined to be non-mutant |
|
|
| Cohort 1 Non-Mutant |
Participants in Cohort 1 whose MET mutation status in baseline ctDNA was determined to be non-mutant |
| OG003 | Cohort 2 Non-Mutant | Participants in Cohort 2 whose MET mutation status in baseline ctDNA was determined to be non-mutant |
|
|
Participants in Cohort 1 whose MET mutation status in baseline ctDNA was determined to be non-mutant
| OG003 | Cohort 2 Non-Mutant | Participants in Cohort 2 whose MET mutation status in baseline ctDNA was determined to be non-mutant |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants who had failed one or two prior lines of therapy and received capmatinib 400 mg orally twice daily
|
|
| Participants |
|
|