Nationwide Phase 2 Study in Norway Using Precision Medicine to Treat Advanced Cancers with Approved Drugs Outside Their Usual Uses

What this Trial Is About

Researchers are evaluating the effectiveness of approved anti-cancer drugs used outside their usual indication for patients with advanced cancer who have specific molecular changes identified through diagnostic testing. This nationwide, phase 2 clinical trial in Norway uses a combined umbrella and basket design with a Simon two-stage model to study various drug and biomarker combinations across different cancer types. Biological samples will be collected at presentation, during treatment, and upon disease progression to better understand drug response and resistance through advanced genetic analyses, including whole genome sequencing. The study involves patients who have advanced cancers no longer benefiting from standard treatments and who have molecular profiles indicating potential benefit from one of the approved drugs in the trial. Participants will receive treatment with drugs such as atezolizumab, alectinib, and others, used beyond their usual indications based on biomarker profiles. Treatment plans are guided by a national molecular tumor board, and fresh tumor biopsies will be collected before treatment to support biomarker studies. New patient cohorts may be opened as needed based on molecular subgroups and drug availability. Participants will be monitored for tumor response, progression-free survival, overall survival, and treatment duration. Data on treatment toxicity will be collected, and all treatment and outcome information, along with molecular screening results, will be reported to the Cancer Registry of Norway. Long-term follow-up will also use national registries to track patient outcomes. Patients who are screened but not enrolled will be followed for 16 weeks to monitor survival and disease progression.

Improving Public Cancer Care by Implementing Precision Medicine in Norway