The study aims, primarily, to provide cancer patients access to promising drugs that have already been studied in terms of their effects on their specific tumor types across several research phases, and that have shown positive results, but that have not yet been made available on the Dutch market for a variety of reasons. Giving patients access to these new drugs will allow for the simultaneous collection of data on the efficacy and safety of the treatment. This additional data can be beneficial for the eventual admission of the drug to the Dutch market.

Patients with cancer for whom no sufficient treatment options are available within the Dutch health care system and who qualify, based on their tumor type or the specific characteristics in the tumor DNA, for treatment with a drug that is available within the DRUG Access Protocol.

In this protocol, patients with solid tumors and a previously established potentially ‘actionable’ tumor profiles (histological or molecular) are treated with a drug that is not yet available to patients in the Netherlands but that is currently in the process of registration. Included in this protocol are drugs for which FDA/EMA registration has been requested, or drugs that are awaiting a positive decision in terms of health care coverage by the Dutch government. Data from these patients will be systematically collected as soon as the patient’s practicing physician reports them to the study team, and grouped together with data from other patients who are being treated with the same unauthorized drug by their practicing physicians. The donation of a pre-treatment tumor biopsy is optional; this can be used in a biomarker analysis at a later time. If the patient agrees to participate in the study, this will be followed up with standard toxicity and efficacy outcomes, including tumor response, progression, free and overall survival, and duration of study treatment.