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Recruiting NCT05384873

Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer

No phase Interventional Lung Cancer, Nonsmall Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunonutrition, Control dietary intervention.
Who it may be relevant to
Registry conditions: Lung Cancer, Nonsmall Cell. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Dietary supplement Immunonutrition
    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
  • Other Control dietary intervention
    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

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: 12 months]
Secondary outcome measures (7)
  • Duration of response [Time frame: 24 months]
  • Overall survival [Time frame: 24 months]
  • Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0] [Time frame: 4 months]
  • Skeletal muscle mass [Time frame: 12 months]
  • Fatigue [Time frame: 12 months]
  • Self-perceived quality of life [Time frame: 12 months]
  • Self-reported physical activity level [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Fondazione IRCCS Policlinico San Matteo — Pavia

Publications

  • Caccialanza R, Cereda E, Agustoni F, Klersy C, Casirati A, Montagna E, Carnio S, Novello S, Milella M, Pilotto S, Trestini I, Buffoni L, Ferrari A, Pedrazzoli P. Multicentre, randomised, open-label, parallel-group, clinical phase II study to evaluate immunonutrition in improving efficacy of immunotherapy in patients with metastatic non-small cell lung cancer, undergoing systematic nutritional coun PMID 36434615

Identifiers

NCT: NCT05384873 · 0020364/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗