Nutritional supplement tested alongside immunotherapy in advanced lung cancer
Tests an immune-boosting nutritional supplement with immunotherapy in adults with advanced lung cancer.
Key facts
- Who runs it
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Where
- Pavia, ItalySee the site
- Trial code
- Registry title
- Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
- Status
- Recruiting
- People taking part
- 180 people, planned
- Started
- 1 Jun 2023
- Expected to end
- 31 Jul 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Immunonutrition
- Control dietary intervention
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic non-small cell lung cancer who start immunotherapy as first treatment and can take oral nutritional supplements.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed metastatic non-small cell lung cancer, squamous or non-squamous. Performance status (ECOG) 2 or lower. Life expectancy of 6 months or more.
- Earlier treatment
- First-line immunotherapy for metastatic disease, alone or with chemotherapy. No earlier treatment for the metastatic disease is mentioned as a condition.
Main reasons for not taking part
- Younger than 18 years
- Cannot sign informed consent
- Needs or already has artificial nutrition support because normal food intake is totally compromised
- Cannot or will not take oral nutritional supplements
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology)
- First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines
- Will to participate by providing written informed consent
- Availability to administer oral supplements and immunotherapy with or without chemotherapy
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Life expectancy ≥ 6 months
Who cannot take part
- Age < 18 years
- Inability to sign an informed consent
- Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
Where in Italy
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyContact: Riccardo Caccialanza, MDTaking people
About the trial
What the trial wants to find out
The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling
The 2 groups in the trial
- ImmunonutritionTreatment being tested
In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs
- Control dietary interventionExisting treatment, for comparison
Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multicentre, Randomised, Open-label, Parallel-group Trial to Evaluate Immunonutrition in Improving Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer, Undergoing Systematic Nutritional Counseling
- Plain-language title
- Nutritional supplement tested alongside immunotherapy in advanced lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 November 2026