Trial · NCT04452877
A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC
NCT04452877, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2025-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC. Trials, record NCT04452877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04452877
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC
- NCT number
- NCT04452877
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Dabrafenib, Trametinib
- First posted
- 2020-07-01
- Last updated
- 2026-01-13
- Results first posted
- 2025-11-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Full Analysis Set (FAS) | Percentage (%) of responders | NUMBER |
| 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 | Full Analysis Set (FAS) | Percentage (%) of responders | NUMBER |
| 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 | Full Analysis Set (FAS) | Months | MEDIAN |
| 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 | Full Analysis Set (FAS) - Subset of participants per local review with confirmed Best Overall Response (BOR) of complete response (CR) or partial response (PR) | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From baseline until death due to any cause, assessed up to approximately 50 months from treatment initiation | Full Analysis Set (FAS) | Months | MEDIAN |
| SECONDARY | Trough Concentration of Dabrafenib | Pre-dose sample at visits week 3, 6 and 12 | Pharmacokinetic Analysis Set (PAS) - Participants with corresponding evaluable PK parameters | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Trough Concentration of Dabrafenib Metabolites (Hydroxy-dabrafenib, and Desmethyl-dabrafenib) | Pre-dose sample at visits week 3, 6 and 12 | Pharmacokinetic Analysis Set (PAS) - Participants with corresponding evaluable PK parameters | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Trough Concentration of Trametinib | Pre-dose sample at visits week 3, 6 and 12 | Pharmacokinetic Analysis Set (PAS) - Participants with corresponding evaluable PK parameters | ng/mL | GEOMETRIC_MEAN |
| 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) | Full Analysis Set (FAS) - Subset of participants with evaluable data at the pre-specified time points | Score on a Scale | MEAN |
| 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) | Full Analysis Set (FAS) - Subset of participants with evaluable data at the pre-specified time points | Score on a Scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR), Central Independent Review Assessed by RECIST v1.1 | Dabrafenib in Combination With Trametinib | 75 | 95% Confidence Interval 58.8 to 87.3 | Percentage (%) of responders | |
| Overall Response Rate (ORR), Investigator Assessed by RECIST v1.1 | Dabrafenib in Combination With Trametinib | 77.5 | 95% Confidence Interval 61.5 to 89.2 | Percentage (%) of responders | |
| Progression Free Survival (PFS), Investigator Assessed by RECIST v1.1 | Dabrafenib in Combination With Trametinib | 13.9 | Full Range 10.2 to 28.3 | Months | |
| Duration of Response (DoR), Investigator Assessed by RECIST v1.1 | Dabrafenib in Combination With Trametinib | 14.9 | Full Range 9.2 to 29.7 | Months | |
| Overall Survival (OS) | Dabrafenib in Combination With Trametinib | 25.3 | Full Range 16.2 to NA | Months | |
| Trough Concentration of Dabrafenib | Dabrafenib in Combination With Trametinib | Week 3 (0 hours pre-dose) | 74.4 | Geometric Coefficient of Variation 74.9 | ng/mL |
| Trough Concentration of Dabrafenib | Dabrafenib in Combination With Trametinib | Week 6 (0 hours pre-dose) | 91.5 | Geometric Coefficient of Variation 109.7 | ng/mL |
| Trough Concentration of Dabrafenib | Dabrafenib in Combination With Trametinib | Week 12 (0 hours pre-dose) | 93.9 | Geometric Coefficient of Variation 212.0 | ng/mL |
| Trough Concentration of Dabrafenib Metabolites (Hydroxy-dabrafenib, and Desmethyl-dabrafenib) | Dabrafenib in Combination With Trametinib | hydroxy-dabrafenib @ Week 3 (0 hours pre-dose) | 81.9 | Geometric Coefficient of Variation 64.7 | ng/mL |
| Trough Concentration of Dabrafenib Metabolites (Hydroxy-dabrafenib, and Desmethyl-dabrafenib) | Dabrafenib in Combination With Trametinib | hydroxy-dabrafenib @ Week 6 (0 hours pre-dose) | 93.8 | Geometric Coefficient of Variation 83.3 | ng/mL |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabrafenib in Combination With Trametinib | 40 | |
| Overall Study | Pharmacokinetic Analysis Set (PAS) | Dabrafenib in Combination With Trametinib | 38 | |
| Overall Study | COMPLETED | Dabrafenib in Combination With Trametinib | 9 | |
| Overall Study | NOT COMPLETED | Dabrafenib in Combination With Trametinib | 31 |
Source ClinicalTrials.gov
Adverse events216
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dabrafenib in Combination With Trametinib (On-treatment Period) | 21 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 0 | 16 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dabrafenib in Combination With Trametinib (On-treatment Period) | 2 | 40 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 0 | 16 | |
| other | Sinus tachycardia | Cardiac disorders | Dabrafenib in Combination With Trametinib (On-treatment Period) | 3 | 40 | |
| other | Sinus tachycardia | Cardiac disorders | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 0 | 16 | |
| other | Supraventricular tachycardia | Cardiac disorders | Dabrafenib in Combination With Trametinib (On-treatment Period) | 2 | 40 | |
| other | Supraventricular tachycardia | Cardiac disorders | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 0 | 16 | |
| other | Ventricular extrasystoles | Cardiac disorders | Dabrafenib in Combination With Trametinib (On-treatment Period) | 3 | 40 | |
| other | Ventricular extrasystoles | Cardiac disorders | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 0 | 16 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabrafenib in Combination With Trametinib (On-treatment Period) | 6 | 40 |
| Total, all-cause mortality | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 12 | 16 |
| Total, other adverse events | Dabrafenib in Combination With Trametinib (On-treatment Period) | 39 | 40 |
| Total, other adverse events | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 1 | 16 |
| Total, serious adverse events | Dabrafenib in Combination With Trametinib (On-treatment Period) | 20 | 40 |
| Total, serious adverse events | Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase) | 1 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39830765 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dabrafenib in Combination With Trametinib (On-treatment Period) vs Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase): deaths from any cause | Trial comparisons |
| Dabrafenib in Combination With Trametinib (On-treatment Period) vs Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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