Osimertinib is a first-line treatment for patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC) with a specific (EGFR) mutation. The current standard dose of osimertinib is 80mg once daily. Based on scientific studies, it is not clear whether such a high dose is needed for the treatment to be effective, whilst osimertinib has more toxic effects at higher doses. We want to investigate whether a longer interval between doses (80mg every other day) can have benefits for patients without affecting the effectiveness of treatment.
Besides the potential positive effects for the patient, we also expect a significant economic benefit from this adjustment. Osimertinib is expensive, with a cost exceeding €6,000 per month in France, Belgium and the Netherlands. Administration every other day could cut treatment costs by half, saving over €35,000 per patient per year.
This study will involve 383 patients in the Netherlands, Belgium and France.
| Title | Increasing the dosing interval of osimertinib in patients with EGFR mutated locally advanced or metastatic non-small cell lung cancer |
| Participants (P) | Adult patients who have been treated for a minimum of 3 months with first-line osimertinib 80 mg QD, with or without platinum-pemetrexed chemotherapy, for locally advanced or metastatic NSCLC exhibiting either an exon 19 deletion or exon 21 L858R EGFR mutation. Patients with brain metastases are excluded. Additionally, all patients must demonstrate radiologic response to treatment. |
| Intervention (I) | Osimertinib 80 mg is administered every other day with or without chemotherapy |
| Control (C) | Osimertinib 80 mg is administered daily with or without chemotherapy |
| Outcome (O) | Primary Endpoint - Progression-free survival (PFS) Secondary trial endpoints -Overall survival (OS) -Patient reported toxicity of any grade (laboratory abnormalities excluded) -Quality of life -Economic assessment |
| Trial Design | Randomized-controlled multicenter non-inferiority trial |
| Sample Size | 383 patients of which 100 in Belgium |
| Trial duration | 6 years (4 years recruitment + 2 years FU) |
| Budget | 762 947,39 € |
| Sponsor | Erasmus MC Cancer Institute - Department of Pulmonary Medicine |
| Belgian Coordinating Centre | UZ Gent |
| Chief Investigator | Anne Marie Dingemans (NL) – Veerle Surmont (BE) |
| Number of participating sites | 10 in Belgium |
