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

ConditionLung Cancer, Nonsmall Cell

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Immunonutrition
Dietary supplement
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 intervention
Other 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 intake.

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: ImmunonutritionExperimental treatment 1 intervention

Group B: Control dietary interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Progression-Free Survival (PFS)

A progression-free survival rate at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 months.

Time frame

12 months

Secondary outcomes

Duration of response

Time to progression

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]

Difference in the incidence of grade \>=3 toxicity, according to CTCAE v5.0

Time frame

4 months

Skeletal muscle mass

Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans

Time frame

12 months

Other outcomes

Serum levels of immunologic markers

Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays

Time frame

12 months

Sponsors and contacts

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Fondazione IRCCS Policlinico San Matteo di Pavia

Lead sponsor

San Luigi Gonzaga Hospital

Collaborator

Azienda Ospedaliera Universitaria Integrata Verona

Collaborator

Humanitas Hospital, Italy

Collaborator

Source ClinicalTrials.gov

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