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Carcinoma, Non-Small-Cell LungPhase 2NCT04452877

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

A Phase 2 study testing Dabrafenib and Trametinib in people with Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Dabrafenib and Trametinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
8 sitesChina
Study dates
19 Aug 2020to 7 Nov 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Participants previously treated should have received no more than 3 prior systemic therapies for metastatic disease, with at least one prior platinum based chemotherapy, and should have documented disease progression on a prior treatment regimen (i.e. RECIST 1.1)
  • Participants who have received prior therapy with checkpoint inhibitor therapy (i.e. anti-PD-1/PD-L1) must have had objective evidence of disease progression (i.e. RECIST v1.1) while on or after this therapy prior to enrollment.
  • Participants with EGFR or ALK mutation who have previously received therapy with EGFR or ALK inhibitor(s) respectively are eligible
  • Measurable disease per RECIST v1.1
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  • 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

Who cannot join

  • Participants with brain or leptomeningeal metastases are excluded if their these metastases are: symptomatic or treated but not clinically and radiographically stable 3 weeks after local therapy or asymptomatic and untreated but >1 cm in the longest dimension
  • Previous treatment with a BRAF inhibitor or a MEK inhibitor
  • All prior anti-cancer treatment-related toxicities must be Grade 2 or less according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.03; NCI, 2009) at the time of enrollment
  • Prior anti-cancer treatment within the last 2 weeks, and prior treatment with immune checkpoint inhibitors within 4 weeks preceding the first dose of the study treatment.
  • Current use of a prohibited medication
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO).
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  • Participants with known history for testing positive for Human Immunodeficiency Virus (HIV)
  • History of another malignancy <3 years prior to starting study treatment or any malignancy with confirmed activating RAS-mutation.
  • Cardiac or cardiac repolarization abnormality
  • A history or current evidence/risk of retinal vein occlusion (RVO) or serous retinopathy
  • History or current interstitial lung disease or non-infectious pneumonitis
  • Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that, in the opinion of the investigator, could interfere with the participant's safety, obtaining informed consent, or compliance with study procedures
  • Pregnant or nursing (lactating) women.
  • Sexually active males (including those that have had a vasectomy) must use a condom during intercourse and should not father a child during this period. The amount of time a patient must use a condom for 16 weeks post treatment discontinuation
  • Participants with active Hepatitis B infection (HbsAg positive)
  • Participants with positive test for hepatitis C ribonucleic acid (HCV RNA)
  • Concurrent participation in other clinical trials using experimental therapies

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Novartis Investigative Site

    Beijing, 100036

  • Novartis Investigative Site

    Changsha, Hunan, 410013

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150081

  • Novartis Investigative Site

    Shanghai, 200032

Other trials in China

About this study

Official title: An Open-Label, Single-arm Study to Evaluate the Safety and Efficacy of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer

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).

Being tested
Dabrafenib, Trametinib
Keywords
Metastatic Non-Small Cell Lung Cancer, NSCLC, Chinese patients, dabrafenib, trametinib, BRAF V600E, treatment naive, pre-treated
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabrafenibDrug

    Also called DRB436

    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.

  • TrametinibDrug

    Also called TMT212

    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

Study groups in NCT04452877
Study groupRoleWhat they receive
Dabrafenib in combination with trametinibExperimentalDabrafenib 150 mg twice daily, trametinib 2 mg once daily
Receives: Drug: Dabrafenib; Drug: Trametinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (11)

  1. 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.

    Measured: 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

  2. 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.

    Measured: From baseline until disease progression or death due to any cause, whichever occurs first, assessed up to approximately 50 months from treatment initiation

  3. 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.

    Measured: 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

  4. 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).

    Measured: From baseline until death due to any cause, assessed up to approximately 50 months from treatment initiation

  5. Trough Concentration of Dabrafenib

    Plasma concentration of dabrafenib were calculated by visit/sampling time point and summarized using descriptive statistics.

    Measured: Pre-dose sample at visits week 3, 6 and 12

  6. 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.

    Measured: Pre-dose sample at visits week 3, 6 and 12

  7. Trough Concentration of Trametinib

    Plasma concentration of trametinib were calculated by visit/sampling time point and summarized using descriptive statistics.

    Measured: Pre-dose sample at visits week 3, 6 and 12

  8. 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.

    Measured: Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation)

  9. 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.

    Measured: Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation)

  10. 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.

    Measured: Baseline (BL), Week 12, End of Treatment (up to approximately 50 months after treatment initiation)

  11. 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.

    Measured: From baseline until end of study, assessed up to approximately 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start19 Aug 2020
  3. Primary completion7 Nov 2024
  4. Study completion7 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04452877
Sponsor's protocol ID
CDRB436ECN01
Status last verified
Dec 2025
First submitted
26 Jun 2020
Last updated
13 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 39830765

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dabrafenib and Trametinib in people with Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR), Central Independent Review Assessed by RECIST v1.1 (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04452877, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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