APICES Acknowledged for its Role in CANTABRICO Clinical Trial
The CANTABRICO phase IIIb single-arm trial reports on first-line durvalumab plus platinum-etoposide followed by durvalumab maintenance in extensive-stage SCLC. APICES was acknowledged for supporting study delivery, analysis, and publication activities.
APICES Acknowledged for its Role in CANTABRICO Clinical Trial
APICES CRO is pleased to announce its contribution to the CANTABRICO study. This is a Phase IIIb clinical trial in Small Cell Lung Cancer (SCLC), recently featured in the Elsevier Lung Cancer Journal.
The study evaluates first-line treatment in patients with extensive-stage SCLC (ES-SCLC) using an initial regimen of up to six cycles of durvalumab plus platinum-etoposide, followed by maintenance with durvalumab. The results demonstrate the feasibility of this approach. It also provides additional options for daily clinical management depending on patient characteristics.
We also acknowledge AstraZeneca Spain and Dr. Dolores Isla for the collaboration and opportunity to contribute to this important study advancing treatment options in oncology.
Key Takeaways: First-in-human trials in the EU are governed by Regulation (EU) No 536/2014 and the EMA’s first-in-human guideline (EMEA/CHMP/SWP/28367/07 Rev 1). Sponsors must submit a complete Clinical Trial Application via the CTIS portal and obtain both Part I...
Key Takeaways: Phase I dose escalation design in the EU is governed by ICH E8(R1), EMA first-in-human guidance (EMA/CHMP/SWP/28367/07 Rev.1), and EU Clinical Trial Regulation 536/2014 via CTIS. The classical 3+3 design is increasingly replaced by model-based...
EU MDR clinical investigation requirements have fundamentally changed how Medtech sponsors plan and execute device studies in Europe. Regulation (EU) 2017/745 replaced the clinical investigation provisions of Directive 93/42/EEC (MDD) and introduced a more stringent, harmonised framework across all 27 EU member states. For sponsors running investigations in Spain, Germany, France, the Netherlands, or any other member state, understanding which pathway applies to their study is the single most consequential regulatory decision before CIP submission.