Trial · NCT04452877
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR), Central Independent Review Assessed by RECIST v1.1 | 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 | 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. |
| Secondary | Overall Response Rate (ORR), Investigator Assessed by RECIST v1.1 | 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 | 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. |
| Secondary | Progression Free Survival (PFS), Investigator Assessed by RECIST v1.1 | From baseline until disease progression or death due to any cause, whichever occurs first, assessed up to approximately 50 months from treatment initiation | 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. |
| Secondary | Duration of Response (DoR), Investigator Assessed by RECIST v1.1 | 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 | 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. |
| Secondary | Overall Survival (OS) | From baseline until death due to any cause, assessed up to approximately 50 months from treatment initiation | 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). |
| Secondary | Trough Concentration of Dabrafenib | Pre-dose sample at visits week 3, 6 and 12 | Plasma concentration of dabrafenib were calculated by visit/sampling time point and summarized using descriptive statistics. |
| Secondary | Trough Concentration of Dabrafenib Metabolites (Hydroxy-dabrafenib, and Desmethyl-dabrafenib) | Pre-dose sample at visits week 3, 6 and 12 | Plasma concentration of dabrafenib metabolites (hydroxy-dabrafenib, and desmethyl-dabrafenib) were calculated by visit/sampling time point and summarized using descriptive statistics. |
| Secondary | Trough Concentration of Trametinib | Pre-dose sample at visits week 3, 6 and 12 | Plasma concentration of trametinib were calculated by visit/sampling time point and summarized using descriptive statistics. |
| Secondary | Mean Change From Baseline in the European Quality of Life (EuroQol)- 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) | 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. |
| 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 | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) | 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. |
| Secondary | Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Lung Cancer Specific Module (EORTC QLQ-LC13) | Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation) | 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. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | From baseline until end of study, assessed up to approximately 50 months | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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