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

NCT05384873 | Recruiting DMC

• 1 other identifier: 0020364/22
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer, Nonsmall Cell

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (7)

• Duration of response

  24 months

• Overall survival

  24 months

• Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]

  4 months

• Skeletal muscle mass

  12 months

• Fatigue

  12 months

Other Outcomes (1)

• Serum levels of immunologic markers

  12 months

Study Arms (2)

Immunonutrition

EXPERIMENTAL

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

Dietary Supplement: Immunonutrition

Control dietary intervention

ACTIVE COMPARATOR

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.

Other: Control dietary intervention

Interventions

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

Immunonutrition

Control dietary intervention OTHER

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.

Control dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• San Luigi Gonzaga Hospital: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• Humanitas Hospital, Italy: collaborator

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

Related Publications (1)

• 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 counseling. BMC Cancer. 2022 Nov 24;22(1):1212. doi: 10.1186/s12885-022-10296-x.

  PMID: 36434615 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Riccardo Caccialanza, MD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Caccialanza, MD

CONTACT

0382501615; r.caccialanza@smatteo.pv.it

Alessandra Ferrari, PharmD

CONTACT

0382503689; alessandra.ferrari@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 20, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

IT (1)