Evidence map›Paper›PMID 28919011›Full record

Trial reportThe Lancet. Oncology2017

Dabrafenib plus trametinib in patients with previously untreated BRAF

David Planchard, Egbert F Smit, Harry J M Groen, Julien Mazieres, Benjamin Besse, Åslaug Helland, Vanessa Giannone, Anthony M D'Amelio, Pingkuan Zhang, Bijoyesh Mookerjee and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIControlled Clinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06062823 (An Open-label Phase II Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations Categorized According to Structural Based Classification), which is not on this map. Cited by 513 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
513citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06062823 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

An Open-label Phase II Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations Categorized According to Structural Based Classification

TypeinterventionalSponsorNational University Hospital, SingaporeRan2024 to 2026Enrolled35ConditionsNSCLCArmsAfatinib 40 MG
3 · Its place in the literature

Who cites it

513 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Trial
  6. Review
  7. Review
  8. [Personalized drug therapy of metastatic lung cancer].Innere Medizin (Heidelberg, Germany) · 2026
    Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Pharmacogenomics in oncology: mutation-targeted therapy and biomarker integration in non-small cell lung cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  15. Cost-Effectiveness of First-Line Immunochemotherapy VersusCurrent oncology (Toronto, Ont.) · 2026
    Article
  16. Article
  17. Article
  18. Article
  19. A Case of Immunotherapy Response to BRAFCancer reports (Hoboken, N.J.) · 2026
    Article
  20. Observational

453 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

David PlanchardGustave Roussy, Villejuif, France.
Egbert F SmitVrije Universiteit VU Medical Centre, Amsterdam, Netherlands.
Harry J M GroenUniversity of Groningen and University Medical Center Groningen, Groningen, Netherlands.
Julien MazieresRangueil-Larrey Hospital and Paul Sabatier University, Toulouse, France.
Benjamin BesseGustave Roussy, Villejuif, France.
Åslaug HellandOslo University Hospital, Department of Oncology, Norwegian Radium Hospital, Oslo, Norway.
Vanessa GiannoneNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Anthony M D'AmelioNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Pingkuan ZhangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Bijoyesh MookerjeeNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Bruce E JohnsonDana-Farber Cancer Institute, Boston, MA, USA. Electronic address: bruce_johnson@dfci.harvard.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBRAF

methodsIn this phase 2, sequentially enrolled, multicohort, multicentre, non-randomised, open-label study, adults (≥18 years of age) with previously untreated metastatic BRAF

findingsBetween April 16, 2014, and Dec 28, 2015, 36 patients were enrolled and treated with first-line dabrafenib plus trametinib. Median follow-up was 15·9 months (IQR 7·8-22·0) at the data cutoff (April 28, 2017). The proportion of patients with investigator-assessed confirmed overall response was 23 (64%, 95% CI 46-79), with two (6%) patients achieving a complete response and 21 (58%) a partial response. All patients had one or more adverse event of any grade, and 25 (69%) had one or more grade 3 or 4 event. The most common (occurring in more than two patients) grade 3 or 4 adverse events were pyrexia (four [11%]), alanine aminotransferase increase (four [11%]), hypertension (four [11%]), and vomiting (three [8%]). Serious adverse events occurring in more than two patients included alanine aminotransferase increase (five [14%]), pyrexia (four [11%]), aspartate aminotransferase increase (three [8%]), and ejection fraction decrease (three [8%]). One fatal serious adverse event deemed unrelated to study treatment was reported (cardiorespiratory arrest).

interpretationDabrafenib plus trametinib represents a new therapy with clinically meaningful antitumour activity and a manageable safety profile in patients with previously untreated BRAF

fundingNovartis.

Indexed as

Administration, OralAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungConfidence IntervalsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleGene Expression Regulation, NeoplasticHumansImidazolesLung NeoplasmsMaximum Tolerated DoseMiddle AgedMutationNeoplasm InvasivenessBRAF protein, humandabrafenibImidazolesOximesProto-Oncogene Proteins B-rafPyridonesPyrimidinonestrametinib

Identifiers

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.