NostraBiome today announced NOSTRA-IO, a prospective, multicentre study evaluating a continuous care and monitoring programme for patients treated with pembrolizumab in routine practice in Romania.
The study will follow 100 adult patients across 4–6 oncology centres for 6 months, in two cohorts: 50 patients with first-line metastatic non-small cell lung cancer (NSCLC), and 50 patients with cervical or endometrial cancer.
Alongside standard oncology care, participants use Nostra:Biome to report symptoms between visits and receive personalised guidance on nutrition, activity and sleep. Their oncologist receives periodic reports. DeepGene gut microbiome profiling takes place at baseline and at month 6.
The primary endpoint is quality of life, measured with the EORTC QLQ-C30 questionnaire at month 6. Treatment decisions remain entirely with the treating physician and are not changed by the study. The platform does not diagnose and does not replace direct contact with the oncology centre.
Because the study has a single arm, with no comparison group, its findings are exploratory: they cannot prove an effect of the platform and do not assess the efficacy of pembrolizumab. Favourable results could support a subsequent controlled study.
Physicians, centres and patients interested in the study can contact the research team at rd@nostrabiome.com.
Study detailsAbout NostraBiome
NostraBiome builds personalised, continuous care for complex health needs, combining proprietary biological models, DeepGene microbiome and DNA testing and the NostraAI app, alongside the care provided by doctors.