Clinical programme · Prospective study
NOSTRA-IO
Integrated continuous care and monitoring for oncology patients treated with pembrolizumab.
A prospective, multicentre, exploratory study evaluating whether continuous between-visit monitoring and personalised supportive care with Nostra:Biome can support quality of life in patients receiving pembrolizumab in routine practice.
- 100
- adult participants
- 2
- cohorts
- 6
- months follow-up
- 4–6
- centres in Romania
Study design
Open-label, single-arm study. Oncological treatment is administered independently of the study, according to approved indications and current practice. Eligibility and treatment choice remain with the treating team.
Cohort A · 50 patients
First-line metastatic NSCLC: pembrolizumab monotherapy (PD-L1 TPS ≥50%) or in combination with chemotherapy, according to histology and approved indication.
Cohort B · 50 patients
Locally advanced cervical cancer treated with chemoradiotherapy and pembrolizumab; persistent, recurrent or metastatic cervical cancer treated with pembrolizumab plus chemotherapy ± bevacizumab; or advanced/recurrent endometrial carcinoma treated first-line with pembrolizumab plus carboplatin–paclitaxel.
Patients who started pembrolizumab up to 12 weeks earlier, without documented progression, may also be included. For locally advanced cervical cancer, inclusion occurs before radiotherapy or within its first two weeks.
The care programme
- 01
Symptom tracking
Regular reporting of symptoms and general condition in the app, followed between scheduled visits.
- 02
Personalised guidance
Recommendations on nutrition, physical activity, sleep and symptom management, adapted to clinical status and tolerance.
- 03
NostraAI support
A digital assistant for supportive questions, never replacing medical evaluation.
- 04
Reports to the oncologist
Periodic summaries of symptoms, weight, adherence and points needing clinical attention.
- 05
Microbiome profiling
DeepGene testing at inclusion and month 6, for exploratory analyses of symptoms and quality of life.
Endpoints
- Primary
- Change from baseline in EORTC QLQ-C30 Global Health Status / Quality of Life at month 6. Questionnaires at inclusion, month 3 and month 6.
- Secondary
- Proportion with ≥10-point GHS/QoL improvement; QLQ-C30 function and symptom scores and PRO-CTCAE; immune-mediated adverse events; treatment delays or interruptions; unplanned emergency visits and hospitalisations.
- Exploratory
- Programme adherence and app use, nutritional status, patient satisfaction, healthcare resource use, tumour response and 6-month PFS from routine assessments, and microbiome changes in relation to patient-reported outcomes.
Safety comes first
Symptoms suggestive of immune-mediated toxicity — such as grade ≥2 diarrhoea, new dyspnoea or cough, extensive rash, endocrine symptoms or jaundice — require prompt contact with the oncology team, following protocol procedures. The platform does not diagnose or treat toxicity, does not change medication and does not replace the usual channels of contact with the oncology centre. Antibiotics and any change in treatment remain solely the physician's decision.
Analysis and limitations
The primary outcome will be analysed with a mixed model for repeated measures, reporting the mean difference and 95% confidence interval. Cohorts are analysed separately; gynaecological sub-cohorts are descriptive. The main limitation is the absence of a comparator arm: results are exploratory and cannot demonstrate a causal effect of the platform or any benefit on the antitumour efficacy of pembrolizumab. A favourable result could support a subsequent controlled study.
Interested in NOSTRA-IO?
Oncologists and centres interested in participating, and patients who would like to know more, can contact the NostraBiome research team.
Or write directly to rd@nostrabiome.com
NOSTRA-IO is an investigational programme. Information on this page is intended for healthcare professionals and interested patients and does not constitute medical advice or a treatment recommendation.