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This was a single-arm, open label, multicenter phase II, study of dabrafenib in combination with trametinib in Chinese participants with BRAF V600E mutation positive, stage IV NSCLC (American joint committee on cancer staging 8th edition). Approximately 40 Chinese adults were to be enrolled in this study. Participants were to be treated with dabrafenib in combination with trametinib until disease progression, start of a new anti-neoplastic therapy, unacceptable toxicity, pregnancy, withdrawal of consent, lost to follow-up, physician's decision, death, or if study be terminated by the sponsor. The general study design was discussed and agreed with China National Medical Products Administration and was based on a similar design used in the global pivotal phase II study (Study 113928 / NCT01336634).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabrafenib in combination with trametinib | Experimental | Dabrafenib 150 mg twice daily, trametinib 2 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabrafenib | Drug | Dabrafenib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Dabrafenib will be administered orally twice daily (150 mg BID) for Days 1-21 of a 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR), Central Independent Review Assessed by RECIST v1.1 | Overall Response Rate (ORR) was defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as per central independent review assessment and according to RECIST 1.1. | From baseline until disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR), Investigator Assessed by RECIST v1.1 | Overall Response Rate (ORR) was defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) by Investigator assessment as per RECIST 1.1 criteria. | From baseline until disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
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Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (according to AJCC 8th edition) that is BRAF V600E mutation-positive by local test result from a qualified assay (NMPA and/or MOH-approved)
Previously treated or untreated for metastatic NSCLC:
Measurable disease per RECIST v1.1
Anticipated life expectancy of at least 3 months
ECOG performance status ≤ 2.
Adequate bone marrow and organ function as defined by the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and/or platelet infusion, or red/white blood cell growth factor administration) as assessed by local laboratory for eligibility: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; PT/INR and PTT ≤ 1.5 x ULN; Serum creatinine < 1.5 mg/dL; Total bilirubin ≤ 1.5 × ULN (upper limit of normal) except for participants with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN, except for participant with liver metastasis, who may only be included if AST/ALT ≤ 5.0 × ULN Albumin ≥ 2.5 g/dL
Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN) as assessed by ECHO or MUGA scan
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 | Harbin | Heilongjiang | 150081 | China | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39830765 | Result | Fan Y, Zhou J, Zhao Y, Yu Y, Yang N, Li J, Wang J, Zhao J, Wang Z, Chen J, Zhu T, Li H, Passos VQ, Bury-Maynard D, Zhang L. Efficacy, safety, and quality of life of dabrafenib plus trametinib treatment in Chinese patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer. Transl Lung Cancer Res. 2024 Dec 31;13(12):3382-3391. doi: 10.21037/tlcr-24-494. Epub 2024 Dec 27. |
| 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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This study was conducted at 7 centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabrafenib in Combination With Trametinib | Dabrafenib 150 mg twice daily, trametinib 2 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabrafenib in Combination With Trametinib | Dabrafenib 150 mg twice daily, trametinib 2 mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR), Central Independent Review Assessed by RECIST v1.1 | Overall Response Rate (ORR) was defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as per central independent review assessment and according to RECIST 1.1. | Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percentage (%) of responders | From baseline until disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
|
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 50 months. Deaths were recorded from study start date until end of post-treatment follow-up (end of study), assessed up to approximately 50 months. On-treatment period (up to 30 days after last dose) and post-treatment follow-up phase (thereafter) are reported separately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabrafenib in Combination With Trametinib (On-treatment Period) | Dabrafenib in combination with trametinib (On-treatment period): Events up to 30 days post-treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1 862 778 8300 | Novartis.email@Novartis.com |
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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 | Mar 13, 2023 | Oct 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2024 | Oct 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
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|
| Trametinib | Drug | Trametinib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Trametinib will be administered orally once daily (2 mg QD) for Days 1-21 of a 21-day cycle |
|
|
| Progression Free Survival (PFS), Investigator Assessed by RECIST v1.1 | Progression Free Survival (PFS) was defined as the time from the date of first dose to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored if no PFS event was observed before the first to occur between: (i) the analysis cut-off date, and (ii) the date when a new anti-neoplastic therapy is started. The censoring date was the date of the last adequate tumor assessment prior to cut-off/start of new anti-neoplastic therapy. | From baseline until disease progression or death due to any cause, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
| Duration of Response (DoR), Investigator Assessed by RECIST v1.1 | Duration of Response (DoR) only applies to participants whose Best Overall Response (BOR) was complete response (CR) or partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to any cause. Participants continuing without progression or death were censored at the date of their last adequate tumor assessment. | From first documented response until first documented progression or death due to any cause, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
| Overall Survival (OS) | Overall Survival (OS) was defined as the time from date of first dose to date of death due to any cause. If a participant was not known to have died, then OS was censored at the latest date the participant was known to be alive (on or before the cut-off date). | From baseline until death due to any cause, assessed up to approximately 50 months from treatment initiation |
| Trough Concentration of Dabrafenib | Plasma concentration of dabrafenib were calculated by visit/sampling time point and summarized using descriptive statistics. | Pre-dose sample at visits week 3, 6 and 12 |
| Trough Concentration of Dabrafenib Metabolites (Hydroxy-dabrafenib, and Desmethyl-dabrafenib) | Plasma concentration of dabrafenib metabolites (hydroxy-dabrafenib, and desmethyl-dabrafenib) were calculated by visit/sampling time point and summarized using descriptive statistics. | Pre-dose sample at visits week 3, 6 and 12 |
| Trough Concentration of Trametinib | Plasma concentration of trametinib were calculated by visit/sampling time point and summarized using descriptive statistics. | Pre-dose sample at visits week 3, 6 and 12 |
| Mean Change From Baseline in the European Quality of Life (EuroQol)- 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) | The EQ-5D-5L is a standardized tool for measuring health-related quality of life (HRQoL). The instrument includes a descriptive system and a visual analogue scale. The descriptive system covers five dimensions (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression), each with five severity levels ranging from 0 (no problems) to 5 (extreme problems) resulting in a 5-digit health code. In China, a country-specific value set is used to convert the five-digit health state into a utility score, ranging from <0 (worse than death) to 1.0 (perfect health). A positive change from baseline indicates improvement; a negative change indicates deterioration. The Visual Analog Scale (VAS) is a 0-100 self-rated health scale, where 0 is the worst and 100 the best imaginable health. A positive change reflects perceived improvement. | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) |
| Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale | The EORTC QLQ-C30 is a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It includes five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale. The GHS/QoL scale has seven possible response scores ranging from 1 (very poor) to 7 (excellent), which are averaged and transformed to a 0-100 scale. A higher score on this scale indicates a better quality of life. The change from baseline in GHS/QoL scores is calculated. A positive change from baseline indicated improvement in the patient's quality of life. | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) |
| Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Lung Cancer Specific Module (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung cancer-specific module designed to supplement the EORTC QLQ-C30 core questionnaire. It focuses on symptoms and side effects particularly relevant to lung cancer patients, including: Cough, Dyspnea (Shortness of breath), Hemoptysis (Coughing up blood), Sore Mouth/Tongue, Dysphagia (Trouble swallowing), Peripheral neuropathy (Tingling Hands/Feet), Alopecia (Hair Loss) and Pain in chest, arm, shoulder, or other areas and an additional dimension (Q13A: "How much did the pain medication help") if Q13: "did you take any medicine for pain" is answered "yes". Each item is scored on a 1 to 4 Likert scale (1 = "Not at all", 4 = "Very much") and then linearly transformed to a 0-100 scale. Improvements in QoL are indicated by decreased scores for the 13 main dimensions and an increased score for question 13A. | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) |
| Percentage of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Treatment Emergent Adverse Events (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after last dose. | From baseline until end of study, assessed up to approximately 50 months |
| Changsha |
| Hunan |
| 410013 |
| China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310003 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310022 | China |
| Novartis Investigative Site | Beijing | 100036 | China |
| Novartis Investigative Site | Guangzhou | 510060 | China |
| Novartis Investigative Site | Shanghai | 200032 | China |
| Progressive Disease |
|
| Withdrawal by Subject |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Overall Response Rate (ORR), Investigator Assessed by RECIST v1.1 | Overall Response Rate (ORR) was defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) by Investigator assessment as per RECIST 1.1 criteria. | Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percentage (%) of responders | From baseline until disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
|
|
|
| Secondary | Progression Free Survival (PFS), Investigator Assessed by RECIST v1.1 | Progression Free Survival (PFS) was defined as the time from the date of first dose to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored if no PFS event was observed before the first to occur between: (i) the analysis cut-off date, and (ii) the date when a new anti-neoplastic therapy is started. The censoring date was the date of the last adequate tumor assessment prior to cut-off/start of new anti-neoplastic therapy. | Full Analysis Set (FAS) | Posted | Median | Full Range | Months | From baseline until disease progression or death due to any cause, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
|
|
|
| Secondary | Duration of Response (DoR), Investigator Assessed by RECIST v1.1 | Duration of Response (DoR) only applies to participants whose Best Overall Response (BOR) was complete response (CR) or partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date is the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to any cause. Participants continuing without progression or death were censored at the date of their last adequate tumor assessment. | Full Analysis Set (FAS) - Subset of participants per local review with confirmed Best Overall Response (BOR) of complete response (CR) or partial response (PR) | Posted | Median | Full Range | Months | From first documented response until first documented progression or death due to any cause, whichever occurs first, assessed up to approximately 50 months from treatment initiation |
|
|
|
| Secondary | Overall Survival (OS) | Overall Survival (OS) was defined as the time from date of first dose to date of death due to any cause. If a participant was not known to have died, then OS was censored at the latest date the participant was known to be alive (on or before the cut-off date). | Full Analysis Set (FAS) | Posted | Median | Full Range | Months | From baseline until death due to any cause, assessed up to approximately 50 months from treatment initiation |
|
|
|
| Secondary | Trough Concentration of Dabrafenib | Plasma concentration of dabrafenib were calculated by visit/sampling time point and summarized using descriptive statistics. | Pharmacokinetic Analysis Set (PAS) - Participants with corresponding evaluable PK parameters | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose sample at visits week 3, 6 and 12 |
|
|
|
| Secondary | Trough Concentration of Dabrafenib Metabolites (Hydroxy-dabrafenib, and Desmethyl-dabrafenib) | Plasma concentration of dabrafenib metabolites (hydroxy-dabrafenib, and desmethyl-dabrafenib) were calculated by visit/sampling time point and summarized using descriptive statistics. | Pharmacokinetic Analysis Set (PAS) - Participants with corresponding evaluable PK parameters | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose sample at visits week 3, 6 and 12 |
|
|
|
| Secondary | Trough Concentration of Trametinib | Plasma concentration of trametinib were calculated by visit/sampling time point and summarized using descriptive statistics. | Pharmacokinetic Analysis Set (PAS) - Participants with corresponding evaluable PK parameters | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose sample at visits week 3, 6 and 12 |
|
|
|
| Secondary | Mean Change From Baseline in the European Quality of Life (EuroQol)- 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) | The EQ-5D-5L is a standardized tool for measuring health-related quality of life (HRQoL). The instrument includes a descriptive system and a visual analogue scale. The descriptive system covers five dimensions (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression), each with five severity levels ranging from 0 (no problems) to 5 (extreme problems) resulting in a 5-digit health code. In China, a country-specific value set is used to convert the five-digit health state into a utility score, ranging from <0 (worse than death) to 1.0 (perfect health). A positive change from baseline indicates improvement; a negative change indicates deterioration. The Visual Analog Scale (VAS) is a 0-100 self-rated health scale, where 0 is the worst and 100 the best imaginable health. A positive change reflects perceived improvement. | Full Analysis Set (FAS) - Subset of participants with evaluable data at the pre-specified time points | Posted | Mean | Standard Deviation | Score on a Scale | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) |
|
|
|
| Secondary | Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale | The EORTC QLQ-C30 is a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It includes five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale. The GHS/QoL scale has seven possible response scores ranging from 1 (very poor) to 7 (excellent), which are averaged and transformed to a 0-100 scale. A higher score on this scale indicates a better quality of life. The change from baseline in GHS/QoL scores is calculated. A positive change from baseline indicated improvement in the patient's quality of life. | Full Analysis Set (FAS) - Subset of participants with evaluable data at the pre-specified time points | Posted | Mean | Standard Deviation | Score on a Scale | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) |
|
|
|
| Secondary | Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Lung Cancer Specific Module (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung cancer-specific module designed to supplement the EORTC QLQ-C30 core questionnaire. It focuses on symptoms and side effects particularly relevant to lung cancer patients, including: Cough, Dyspnea (Shortness of breath), Hemoptysis (Coughing up blood), Sore Mouth/Tongue, Dysphagia (Trouble swallowing), Peripheral neuropathy (Tingling Hands/Feet), Alopecia (Hair Loss) and Pain in chest, arm, shoulder, or other areas and an additional dimension (Q13A: "How much did the pain medication help") if Q13: "did you take any medicine for pain" is answered "yes". Each item is scored on a 1 to 4 Likert scale (1 = "Not at all", 4 = "Very much") and then linearly transformed to a 0-100 scale. Improvements in QoL are indicated by decreased scores for the 13 main dimensions and an increased score for question 13A. | Full Analysis Set (FAS) - Subset of participants with evaluable data at the pre-specified time points | Posted | Mean | Standard Deviation | Score on a Scale | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) |
|
|
|
| Secondary | Percentage of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Treatment Emergent Adverse Events (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after last dose. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | From baseline until end of study, assessed up to approximately 50 months |
|
|
|
| 6 |
| 40 |
| 20 |
| 40 |
| 39 |
| 40 |
| EG001 | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | Dabrafenib in combination with trametinib (Post-treatment follow-up phase): Events in the post-treatment follow-up phase | 12 | 16 | 1 | 16 | 1 | 16 |
| Acute coronary syndrome | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Malaise | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Pyrexia | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Optic disc haemorrhage | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Visual field defect | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Chest discomfort | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Chest pain | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Chills | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Fatigue | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Influenza like illness | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Pain | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Pyrexia | General disorders and administration site conditions | MedDRA (23.1) | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Urinary occult blood positive | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
|
| Albuminuria | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (23.1) | 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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| Week 12 (0 hours pre-dose) |
|
|
|
| hydroxy-dabrafenib @ Week 12 (0 hours pre-dose) |
|
|
| desmethyl-dabrafenib @ Week 3 (0 hours pre-dose) |
|
|
| desmethyl-dabrafenib @ Week 6 (0 hours pre-dose) |
|
|
| desmethyl-dabrafenib @ Week 12 (0 hours pre-dose) |
|
|
|
| Week 12 (0 hours pre-dose) |
|
|
|
| Self-Care - Change from BL @ Week 12 |
|
|
| Self-Care - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Usual Activities - Change from BL @ Week 12 |
|
|
| Usual Activities - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Pain/Discomfort - Change from BL @ Week 12 |
|
|
| Pain/Discomfort - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Anxiety/Depression - Change from BL @ Week 12 |
|
|
| Anxiety/Depression - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Visual Analog Scale (VAS) - Change from BL @ Week 12 |
|
|
| Visual Analog Scale (VAS) - Change from BL @ End of Treatment (EOT) Disposition |
|
|
|
| Quality of Life - Change from BL @ Week 12 |
|
|
| Quality of Life - Change from BL @ End of Treatment (EOT) Disposition |
|
|
|
| Cough up blood - Change from BL @ Week 12 |
|
|
| Cough up blood - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Shortness of breath when resting - Change from BL @ Week 12 |
|
|
| Shortness of breath when resting - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Shortness of breath when walking - Change from BL @ Week 12 |
|
|
| Shortness of breath when walking - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Shortness of breath when climbing stairs - Change from BL @ Week 12 |
|
|
| Shortness of breath when climbing stairs - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Sore Mouth/Tongue - Change from BL @ Week 12 |
|
|
| Sore Mouth/Tongue - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Trouble swallowing - Change from BL @ Week 12 |
|
|
| Trouble swallowing - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Tingling Hands/Feet - Change from BL @ Week 12 |
|
|
| Tingling Hands/Feet - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Hair Loss - Change from BL @ Week 12 |
|
|
| Hair Loss - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Pain in chest - Change from BL @ Week 12 |
|
|
| Pain in chest - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Pain in Arm/Shoulder - Change from BL @ Week 12 |
|
|
| Pain in Arm/Shoulder - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Pain in Other Body Areas - Change from BL @ Week 12 |
|
|
| Pain in Other Body Areas - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Any medicine for pain? - Change from BL @ Week 12 |
|
|
| Any medicine for pain? - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Pain Medication Helpful? - Change from BL @ Week 12 |
|
|
| Pain Medication Helpful? - Change from BL @ End of Treatment (EOT) Disposition |
|
|
| Title | Measurements |
|---|---|
|
| Treatment related AEs with grade >= 3 |
|
| Serious Adverse Events (SAEs) |
|
| Treatment related SAEs |
|
| Fatal SAEs |
|
| Treatment related Fatal SAEs |
|
| Adverse Events (AEs) leading to discontinuation |
|
| Treatment related AEs leading to discontinuation |
|
| AEs leading to dose adjustment/interruption |
|
| AEs requiring additional therapy |
|