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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001578-31 | EudraCT Number |
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Company decision not related to any safety concerns.
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The purpose of the study was to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.
Twenty-two patients with advanced or metastatic lung cancer, with these specific mutations in the MET gene but without changes in their epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes, were enrolled in this study. Participants were randomly assigned to get either capmatinib or docetaxel in a 2 to 1 ratio. The randomization was stratified by prior lines of systemic therapy received for advanced/metastatic disease (one line vs. two lines).
During treatment, visits were scheduled every 21 days.
For all participants, the respective treatment (either with capmatinib or docetaxel) could be continued beyond initial disease progression as per RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there was evidence of clinical benefit, and the participant wished to continue on the study treatment. After treatment discontinuation, all participants were followed for safety evaluations during the safety follow-up period, and the participant's status was collected every 12 weeks as part of the survival follow-up.
Participants randomized to docetaxel treatment were eligible to cross over to receive capmatinib treatment after BIRC-confirmed, RECIST 1.1-defined progressive disease and after meeting the eligibility criteria prior to crossover. This was the extension treatment phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capmatinib | Experimental | 400 mg, capmatinib tablets, administered orally twice daily |
|
| Docetaxel | Active Comparator | Docetaxel 75 mg/m^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capmatinib | Drug | 400 mg, capmatinib tablets, administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1 | Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by BIRC according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date. | From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (ORR) Per RECIST 1.1 by BIRC | Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1. 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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Key Inclusion Criteria:
Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC (according to Version 8 of the American Joint Committee on Cancer (AJCC) Staging Manual) at the time of study entry.
Histologically or cytologically confirmed diagnosis of NSCLC that was:
Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample) with quality and quantity sufficient to allow assessment of METΔex14 mutation status (as defined in the study [laboratory manual]). This pertained to all participants, including those who had a METΔex14 mutation result from a local test. Tumor samples must have contained at least 10% tumor content.
6. Participants must have progressed on one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB/IIIC [not candidates for surgery, radiation or multi modality therapy] or IV NSCLC) and must have been docetaxel naïve and candidates for single agent chemotherapy (docetaxel). Treatment failure was defined as documented disease progression or intolerance to treatment, however, participants must have progressed on or after the last therapy before study entry.
At least one measurable lesion as defined by RECIST 1.1
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Life expectancy of at least 3 months.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Leuven | 3000 | Belgium | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| 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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All inclusion and exclusion criteria were checked at screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capmatinib | 400 mg, capmatinib tablets, administered orally twice daily |
| FG001 | Capmatinib Extension Crossover Treatment | 400 mg, capmatinib tablets, administered orally twice daily to participants treated with docetaxel who crossed over to capmatinib treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Treatment Phase |
|
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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 | Feb 24, 2022 | Sep 23, 2024 |
Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after blinded independent review committee (BIRC)-confirmed, RECIST 1.1- defined disease progression.
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| Docetaxel | Drug | Docetaxel 75 mg/m^2 by intravenous infusion every 21 days |
|
| Up to approximately 21 months |
| Overall Response Rate (ORR) Per RECIST 1.1 by Investigator | Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1. 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 21 months |
| Time to Response (TTR) Per RECIST 1.1 by BIRC | Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1. 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. | From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months |
| Time to Response (TTR) Per RECIST 1.1 by Investigator | Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1. 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. | From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months |
| Duration of Response (DOR) Per RECIST 1.1 by BIRC | Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause. 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. | From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months |
| Duration of Response (DOR) Per RECIST 1.1 by Investigator | Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause. 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. | From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months |
| Disease Control Rate (DCR) Per RECIST 1.1 by BIRC | Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1. 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 progressive disease. | Up to approximately 21 months |
| Disease Control Rate (DCR) Per RECIST 1.1 by Investigator | Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by local review according to RECIST 1.1. 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 progressive disease. | Up to approximately 21 months |
| Progression-free Survival (PFS) Per Investigator Using RECIST v1.1 | Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by local review according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. | From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months |
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death due to any cause. | From randomization to death due to any cause, assessed up to approximately 36 months |
| Overall Intracranial Response Rate (OIRR) | Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose. | Up to approximately 21 months |
| Duration of Intracranial Response (DOIR) | Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer. | From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months |
| Time to Intracranial Response (TTIR) | Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed. | From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months |
| Intracranial Disease Control Rate (IDCR) | Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose. | Up to approximately 21 months |
| Plasma Capmatinib Concentration | Plasma concentrations of capmatinib. Blood samples were collected at indicated time points for pharmacokinetic analysis. | Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration was 21 days. |
| Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. CFB = change from baseline. | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. |
| Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included coughing, hemoptysis, dyspnea, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from "not at all" to "very much." Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. CFB = change from baseline. | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. |
| Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts- the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. CFB = change from baseline. | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. |
| Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included chest pain, cough, and dyspnea and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from "not at all" to "very much." Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. Time to symptom deterioration for chest pain, cough and dyspnea was assessed. Deterioration was assessed by the investigator. | Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days. |
| Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time to deterioration in QoL from EORTC-QLQ-C30 was assessed. Deterioration was assessed by the investigator. | Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days. |
| Barretos |
| São Paulo |
| 14784 400 |
| Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01246 000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04014-002 | Brazil |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Sofia | 1303 | Bulgaria |
| Novartis Investigative Site | Sofia | 1407 | Bulgaria |
| Novartis Investigative Site | Caen | 14021 | France |
| Novartis Investigative Site | Paris | 75231 | France |
| Novartis Investigative Site | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Gauting | Bavaria | 82131 | Germany |
| Novartis Investigative Site | Regensburg | Bavaria | 93053 | Germany |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Berlin | 14165 | Germany |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Oldenburg | 26121 | Germany |
| Novartis Investigative Site | Törökbálint | Pest County | 2045 | Hungary |
| Novartis Investigative Site | Budapest | 1121 | Hungary |
| Novartis Investigative Site | Pune | Maharashtra | 411013 | India |
| Novartis Investigative Site | New Delhi | National Capital Territory of Delhi | 110076 | India |
| Novartis Investigative Site | Vellore | Tamil Nadu | 632 004 | India |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Roma | RM | 00128 | Italy |
| Novartis Investigative Site | Vilnius | LT-08660 | Lithuania |
| Novartis Investigative Site | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Novartis Investigative Site | Kuantan | Pahang | 25100 | Malaysia |
| Novartis Investigative Site | Pulau Pinang | 10990 | Malaysia |
| Novartis Investigative Site | Nijmegen | 6500HB | Netherlands |
| Novartis Investigative Site | Lisbon | 1769 001 | Portugal |
| Novartis Investigative Site | Matosinhos Municipality | 4454 513 | Portugal |
| Novartis Investigative Site | Nizhny Novgorod | 603081 | Russia |
| Novartis Investigative Site | Omsk | 644013 | Russia |
| Novartis Investigative Site | Pushkin Saint Petersburg | 196603 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Port Elizabeth | Western Cape | 6045 | South Africa |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Valencia | 46026 | Spain |
| Novartis Investigative Site | Songkhla | Hat Yai | 90110 | Thailand |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension Treatment Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Capmatinib | 400 mg, capmatinib tablets, administered orally twice daily |
| BG001 | Docetaxel | Docetaxel 75 mg/m^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 | Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1 | Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by BIRC according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months |
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| Secondary | Overall Response (ORR) Per RECIST 1.1 by BIRC | Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1. 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 full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 21 months |
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| Secondary | Overall Response Rate (ORR) Per RECIST 1.1 by Investigator | Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1. 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 full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 21 months |
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| Secondary | Time to Response (TTR) Per RECIST 1.1 by BIRC | Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1. 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 full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only. | Posted | Median | Full Range | months | From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months |
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| Secondary | Time to Response (TTR) Per RECIST 1.1 by Investigator | Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1. 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 full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only. | Posted | Median | Full Range | months | From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months |
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| Secondary | Duration of Response (DOR) Per RECIST 1.1 by BIRC | Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause. 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 full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only. | Posted | Median | 95% Confidence Interval | months | From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months |
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| Secondary | Duration of Response (DOR) Per RECIST 1.1 by Investigator | Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause. 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 full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for responders only. | Posted | Median | 95% Confidence Interval | months | From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months |
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| Secondary | Disease Control Rate (DCR) Per RECIST 1.1 by BIRC | Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1. 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 progressive disease. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 21 months |
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| Secondary | Disease Control Rate (DCR) Per RECIST 1.1 by Investigator | Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by local review according to RECIST 1.1. 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 progressive disease. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 21 months |
|
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| Secondary | Progression-free Survival (PFS) Per Investigator Using RECIST v1.1 | Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by local review according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death due to any cause. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Median | 95% Confidence Interval | months | From randomization to death due to any cause, assessed up to approximately 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Intracranial Response Rate (OIRR) | Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose. | The full analysis set - brain metastases (FAS-BM) comprised all participants in the FAS who had measurable and/or non-measurable brain metastases at baseline as determined by the BIRC and at least one post-baseline assessment. The FAS-BM was used in the analyses of intracranial anti-tumor activity per RANO-BM criteria. Data are reported for responders only. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 21 months |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Intracranial Response (DOIR) | Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer. | The duration of intracranial response could not be analyzed as there were no participants with intracranial response. The analysis population was all participants with intracranial response. | Posted | From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Time to Intracranial Response (TTIR) | Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed. | The median time to intracranial response was not evaluable in both treatment arms as there were no responders. | Posted | From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Intracranial Disease Control Rate (IDCR) | Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose. | The full analysis set - brain metastases (FAS-BM) comprised all participants in the FAS who had measurable and/or non-measurable brain metastases at baseline as determined by the BIRC and at least one post-baseline assessment. The FAS-BM was used in the analyses of intracranial anti-tumor activity per RANO-BM criteria. Data are reported for responders only. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 21 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Plasma Capmatinib Concentration | Plasma concentrations of capmatinib. Blood samples were collected at indicated time points for pharmacokinetic analysis. | The pharmacokinetic analysis set (PAS) included all participants who received at least one dose of capmatinib and had at least one steady state evaluable post-baseline capmatinib concentration measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration was 21 days. |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. CFB = change from baseline. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included coughing, hemoptysis, dyspnea, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from "not at all" to "very much." Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. CFB = change from baseline. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts- the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. CFB = change from baseline. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. Data are reported for participants with baseline and respective post-baseline measurements. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days. |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13) | EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included chest pain, cough, and dyspnea and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from "not at all" to "very much." Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. Time to symptom deterioration for chest pain, cough and dyspnea was assessed. Deterioration was assessed by the investigator. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Median | 95% Confidence Interval | months | Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days. |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 | EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time to deterioration in QoL from EORTC-QLQ-C30 was assessed. Deterioration was assessed by the investigator. | The full analysis set (FAS) comprised all participants to whom study treatment was assigned by randomization, regardless of whether or not the treatment was administered. | Posted | Median | 95% Confidence Interval | months | Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days. |
| ||||||||||||||||||||||||||||||
| Post-Hoc | All Collected Deaths | On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date. | The safety set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | On-treatment deaths: Up to approximately 117 weeks. Post-treatment survival follow-up deaths: Up to an additional 36 weeks. |
|
|
From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks. Deaths were collected in the post-treatment phase from 31 days after last dose of study medication until the end of the study, up to approximately 36 additional weeks. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes participants who entered the post-treatment survival follow-up period.
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 | Capmatinib (On-treatment) | 400 mg, capmatinib tablets, administered orally twice daily | 2 | 15 | 3 | 15 | 14 | 15 |
| EG001 | Docetaxel (On-treatment) | Docetaxel 75 mg/m^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle | 0 | 6 | 2 | 6 | 5 | 6 |
| EG002 | Capmatinib Extension Crossover Treatment (On-treatment) | 400 mg, capmatinib tablets, administered orally twice daily to participants treated with docetaxel who crossed over to capmatinib treatment. | 0 | 5 | 1 | 5 | 4 | 5 |
| EG003 | Capmatinib (Post-treatment Survival Follow-up) | Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period. | 7 | 13 | 0 | 0 | 0 | 0 |
| EG004 | Docetaxel (Post-treatment Survival Follow-up) | Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period. | 5 | 6 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myxoedema | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Eyelid infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinolaryngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Creatinine renal clearance increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Penile dermatitis | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Perineal rash | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Aphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2024 | Sep 23, 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 |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Unknown |
|
|
|
|
|
|
|
| Participants |
|
|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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