A Phase 4 interventional study of dabrafenib and trametinib in Melanoma, Non Small Cell Lung Cancer and Solid Tumor, sponsored by Novartis Pharmaceuticals. Recruiting at 35 sites in 14 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
Exclusion Criteria:
Patients in this study may receive: \- monotherapy of dabrafenib
Drug: dabrafenib
Patients in this study may receive: \- monotherapy of trametinib
Drug: trametinib
Patients in this study may receive: \- the combination of dabrafenib and trametinib
Drug: dabrafenib · Drug: trametinib
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinib is available in tablets (0.5mg, 2mg dose)
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
Time frame: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Clinical Benefit Assessment by investigator
To evaluate clinical benefit as assessed by the Investigator
Time frame: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Plan to share: 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
No publications or documents are linked to this record.
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