NCT04452877 is a Phase 2 clinical trial of Dabrafenib in Carcinoma, Non-Small-Cell Lung, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT04452877?

NCT04452877 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT04452877?

Interventions in NCT04452877: Dabrafenib, Trametinib.

What condition does NCT04452877 study?

NCT04452877 studies Carcinoma, Non-Small-Cell Lung.

Is NCT04452877 still recruiting?

NCT04452877 is currently completed. Last updated 13 January 2026.

Are results published for NCT04452877?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-13 · How we verify

NCT04452877

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC

Completed Phase 2 Results posted Last updated 13 January 2026

What this trial tests

Phase 2 trial testing Dabrafenib in Carcinoma, Non-Small-Cell Lung in 40 participants. Completed in 7 November 2024.

Timeline

19 August 2020

Primary endpoint
7 November 2024

7 November 2024

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	19 August 2020
Primary completion	7 November 2024
Estimated completion	7 November 2024
Sites	8 locations across China

Drugs / interventions tested

Dabrafenib (dabrafenib) — full drug profile →
Trametinib (trametinib) — full drug profile →

Conditions studied

Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 99, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR), Central Independent Review Assessed by RECIST v1.1 Primary · 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.

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	75	58.8 – 87.3

Overall Response Rate (ORR), Investigator Assessed by RECIST v1.1 Secondary · 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.

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	77.5	61.5 – 89.2

Progression Free Survival (PFS), Investigator Assessed by RECIST v1.1 Secondary · 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.

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	13.9	10.2 – 28.3

Duration of Response (DoR), Investigator Assessed by RECIST v1.1 Secondary · 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.

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	14.9	9.2 – 29.7

Overall Survival (OS) Secondary · 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).

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	25.3	16.2 – NA

Trough Concentration of Dabrafenib Secondary · 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.

Week 3 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	74.4	± 74.9

Week 6 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	91.5	± 109.7

Week 12 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	93.9	± 212.0

Trough Concentration of Dabrafenib Metabolites (Hydroxy-dabrafenib, and Desmethyl-dabrafenib) Secondary · 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.

hydroxy-dabrafenib @ Week 3 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	81.9	± 64.7

hydroxy-dabrafenib @ Week 6 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	93.8	± 83.3

hydroxy-dabrafenib @ Week 12 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	100	± 135.6

desmethyl-dabrafenib @ Week 3 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	510	± 81.4

desmethyl-dabrafenib @ Week 6 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	468	± 69.2

desmethyl-dabrafenib @ Week 12 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	430	± 100.9

Trough Concentration of Trametinib Secondary · 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.

Week 3 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	12.7	± 35.0

Week 6 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	13.0	± 29.5

Week 12 (0 hours pre-dose)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	11.7	± 37.0

Mean Change From Baseline in the European Quality of Life (EuroQol)- 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) Secondary · 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

Mobility - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.09	± 0.631

Mobility - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.06	± 0.725

Self-Care - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.33	± 0.174

Self-Care - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.11	± 0.323

Usual Activities - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.00	± 0.433

Usual Activities - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.17	± 0.383

Pain/Discomfort - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.33	± 0.816

Pain/Discomfort - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.17	± 0.618

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 Secondary · 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 t

Global Health Status - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.18	± 0.882

Global Health Status - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.06	± 0.938

Quality of Life - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.06	± 0.747

Quality of Life - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.28	± 0.669

Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Lung Cancer Specific Module (EORTC QLQ-LC13) Secondary · 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

Cough - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.52	± 0.712

Cough - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.65	± 0.606

Cough up blood - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.12	± 0.331

Cough up blood - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.00	± 0.000

Shortness of breath when resting - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.03	± 0.394

Shortness of breath when resting - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.12	± 0.332

Shortness of breath when walking - Change from BL @ Week 12

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	-0.12	± 0.650

Shortness of breath when walking - Change from BL @ End of Treatment (EOT) Disposition

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0.00	± 0.791

Percentage of Participants With Adverse Events (AEs) Secondary · 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.

Adverse Events (AEs)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	39

Treatment related AEs

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	37

AEs with grade >= 3

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	27

Treatment related AEs with grade >= 3

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	18

Serious Adverse Events (SAEs)

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	20

Treatment related SAEs

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	11

Fatal SAEs

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	1

Treatment related Fatal SAEs

Group	Value	95% CI
Dabrafenib in Combination With Trametinib	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 4.9999%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dabrafenib in Combination With Trametinib (On-treatment Period)

Serious: 20/40 (50%)

Deaths: 6/40

Dabrafenib in Combination With Trametinib (Post-treatment Follow-up Phase)

Serious: 1/16 (6%)

Deaths: 12/16

Serious adverse events (24 terms)

Reaction	System	Dabrafenib in Combination …	Dabrafenib in Combination …
Pyrexia	General disorders and administration site conditions	—	—
Pneumonia	Infections and infestations	—	—
Blood creatinine increased	Investigations	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Acute coronary syndrome	Cardiac disorders	—	—
Arteriosclerosis coronary artery	Cardiac disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Coronary artery disease	Cardiac disorders	—	—
Pericardial effusion	Cardiac disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Malaise	General disorders and administration site conditions	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—
Infectious pleural effusion	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Type 2 diabetes mellitus	Metabolism and nutrition disorders	—	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Altered state of consciousness	Nervous system disorders	—	—
Cerebral haemorrhage	Nervous system disorders	—	—
Chronic kidney disease	Renal and urinary disorders	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (84 terms — click to expand)

Reaction	System	Dabrafenib in Combination …	Dabrafenib in Combination …
Anaemia	Blood and lymphatic system disorders	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—
Pyrexia	General disorders and administration site conditions	—	—
Aspartate aminotransferase increased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—
Proteinuria	Renal and urinary disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Alanine aminotransferase increased	Investigations	—	—
White blood cell count decreased	Investigations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
COVID-19	Infections and infestations	—	—
Lipase increased	Investigations	—	—
Weight decreased	Investigations	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—
Pneumonia	Infections and infestations	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Blood creatine phosphokinase increased	Investigations	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Platelet count decreased	Investigations	—	—
Haematuria	Renal and urinary disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Weight increased	Investigations	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Blood creatinine increased	Investigations	—	—
Urinary occult blood positive	Investigations	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Hypertension	Vascular disorders	—	—
Cataract	Eye disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Fatigue	General disorders and administration site conditions	—	—
Amylase increased	Investigations	—	—

Most-reported serious reactions: Pyrexia, Pneumonia, Blood creatinine increased, Dyspnoea, Anaemia, Acute coronary syndrome, Arteriosclerosis coronary artery, Cardiac failure.

Data from ClinicalTrials.gov NCT04452877 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Mechanisms and management of 3rd‑generation EGFR‑TKI resistance in advanced non‑small cell lung cancer (Review).
He J, Huang Z, Han L, Gong Y, et al · · 2021 · cited 232× · PMID 34558640 · DOI 10.3892/ijo.2021.5270
Current treatments for non-small cell lung cancer.
Guo Q, Liu L, Chen Z, Fan Y, et al · · 2022 · cited 75× · PMID 36033435 · DOI 10.3389/fonc.2022.945102
Acquired Resistance to Osimertinib in EGFR-Mutated Non-Small Cell Lung Cancer: How Do We Overcome It?
Bertoli E, De Carlo E, Del Conte A, Stanzione B, et al · · 2022 · cited 34× · PMID 35805940 · DOI 10.3390/ijms23136936
Targeted therapies in non-small cell lung cancer: present and future.
McLaughlin J, Berkman J, Nana-Sinkam P. · · 2023 · cited 11× · PMID 37675274 · DOI 10.12703/r/12-22
Resistance of Lung Cancer to EGFR-Specific Kinase Inhibitors: Activation of Bypass Pathways and Endogenous Mutators.
Marrocco I, Yarden Y. · · 2023 · cited 10× · PMID 37894376 · DOI 10.3390/cancers15205009
Annual progress of clinical research on targeted therapy for nonsmall cell lung cancer in 2022.
Huang Y, Zhang L. · · 2023 · cited 9× · PMID 38090373 · DOI 10.1002/cai2.56
Strategies to Overcome Resistance to Osimertinib in EGFR-Mutated Lung Cancer.
Romaniello D, Morselli A, Marrocco I. · · 2025 · cited 4× · PMID 40243603 · DOI 10.3390/ijms26072957
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.
Fan Y, Zhou J, Zhao Y, Yu Y, et al · · 2024 · cited 1× · PMID 39830765 · DOI 10.21037/tlcr-24-494

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04452877 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 13 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04452877.

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