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

Not Applicable

Recruiting

• Conditions: Lung Cancer, Nonsmall Cell

• Registration Number: NCT05384873
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-20
• Study Start: 2023-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	24 months	Overall survival
Duration of response	24 months	Time to progression
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]	4 months	Difference in the incidence of grade \>=3 toxicity, according to CTCAE v5.0
Skeletal muscle mass	12 months	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans
Fatigue	12 months	Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire
Self-perceived quality of life	12 months	Change in quality of life during the study as assessed by validated questionnaires
Self-reported physical activity level	12 months	Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy