Lung Cancer, Nonsmall CellMURALNCT05384873

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

A study testing Immunonutrition in people with Lung Cancer, Nonsmall Cell, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Nonsmall Cell
What is being tested?: Immunonutrition
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteItaly
Study dates: 1 Jun 2023to 31 Jul 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Riccardo Caccialanza, MD contact

0382501615 ext. 0039

r.caccialanza@smatteo.pv.it

Alessandra Ferrari, PharmD contact

0382503689 ext. 0039

alessandra.ferrari@smatteo.pv.it

Italy1 site, 1 recruiting

Fondazione IRCCS Policlinico San Matteo
Pavia
Riccardo Caccialanza, MD, +390382501615, r.caccialanza@smatteo.pv.it
Recruiting

Other trials in Italy

About this study

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

Conditions: Lung Cancer, Nonsmall Cell
Being tested: Immunonutrition, Control dietary intervention
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImmunonutritionDietary 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 interventionOther
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.

Study groups in NCT05384873
Study group	Role	What they receive
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 Receives: 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. Receives: Other: Control dietary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (7)

Duration of response
Time to progression
Measured: 24 months
Overall survival
Overall survival
Measured: 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
Measured: 4 months
Skeletal muscle mass
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans
Measured: 12 months
Fatigue
Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire
Measured: 12 months
Self-perceived quality of life
Change in quality of life during the study as assessed by validated questionnaires
Measured: 12 months
Self-reported physical activity level
Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202331 Jul 2028

First posted20 May 2022
Study start1 Jun 2023
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05384873
Sponsor's protocol ID: 0020364/22
Acronym: MURAL
Status last verified: Nov 2026
First submitted: 9 May 2022
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee

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 counseling. BMC Cancer. 2022 Nov 24;22(1):1212. doi: 10.1186/s12885-022-10296-x.
PubMed 36434615

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05384873
Acronym / sponsor ID: MURAL / 0020364/22
Conditions: Lung Cancer, Nonsmall Cell
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 180 participants (estimated)
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
Collaborators: San Luigi Gonzaga Hospital, Azienda Ospedaliera Universitaria Integrata Verona, Humanitas Hospital, Italy
Study start: 1 Jun 2023 (actual)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Jul 2028 (estimated)
First posted: 20 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immunonutrition	Experimental	Dietary Supplement: ImmunonutritionIn 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	Active comparator	Other: Control dietary interventionPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ImmunonutritionIn 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 interventionPatients 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

Primary outcome

Progression-Free Survival (PFS)
Time frame: 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.

7 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Derived from this study: PubMed 36434615Caccialanza 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.
Individual participant dataSharing planned: Undecided. Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Riccardo Caccialanza, MD contact

0382501615 ext. 0039

r.caccialanza@smatteo.pv.it

Alessandra Ferrari, PharmD contact

0382503689 ext. 0039

alessandra.ferrari@smatteo.pv.it

Riccardo Caccialanza, MD principal investigator

Fondazione IRCCS Policlinico San Matteo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Immunonutrition in people with Lung Cancer, Nonsmall Cell, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Riccardo Caccialanza, MD (0382501615 ext. 0039, r.caccialanza@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05384873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.