Non-Small Cell Lung Cancer With EGFR MutationPhase 3NCT05852990
Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
A Phase 3 study testing Glutamine plus L. reuteri in people with Non-Small Cell Lung Cancer With EGFR Mutation, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer With EGFR Mutation
- What is being tested?
- Glutamine plus L. reuteri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2022to 12 Dec 2027
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes
- ≥ 18 years old
- Pathologically confirmed diagnosis of NSCLC
- Stage IIIB - IV by the American Joint Committee of Cancer Version 8.
- Candidates to receive EGFR-TKI treatment (1st \& 2nd generation TKI)
- ECOG score ≤ 2
- Life expectancy > eight weeks
- Signed written informed consent
Who cannot join
- Patients who cannot attend the first protocol appointment.
- Treatment with other anti-cancer therapy
- Participating in other clinical trials in the former four weeks
- Any other serious condition or uncontrolled active infection, altered mental status or psychiatric disorder that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results.
- Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.
- Active HIV infection.
- Breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerologia de Mexico
Mexico City, Mexico City, 14080
Oscar G Arrieta Rodriguez, M.D., M.Sc.
About this study
Official title: Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer
This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy.
The main question it aims to answer is ¿What is the effect of glutamine plus L. reuteri added to an astringent diet in preventing diarrhea generated by TKI therapy?
Patients will receive an astringent diet supplemented with 10 grams of glutamine and L. reuteri (100 million CFU). Researchers will compare the Glutamine plus L. reuteri diet with a standard astringent diet to see if TKI therapy diarrhea is prevented.
Read the detailed description
Patients in the experimental group will receive two sachets of Glutapak-R every twelve hours for up to six weeks alongside treating physician-chosen EGFR therapy. Patients in the control group will receive a standard-of-care diet.
All patients will receive nutritional counseling every two weeks.
- Being tested
- Glutamine plus L. reuteri
- Keywords
- Non-Small Cell Lung Cancer, EGFR mutation, Glutamine, Lactobacillus reuteri, standard-care diet
- 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.
Glutamine plus L. reuteriCombination product
Also called Glutapak-R
Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
| Study group | Role | What they receive |
|---|---|---|
| Intervention diet | Experimental | Astringent diet supplemented with one sachet containing 10 grams of glutamine plus 100 million Colony Forming Units (CFU) of Lactobacillus reueri every 12 hours, from baseline treatment up to 6 weeks or death. Receives: Combination Product: Glutamine plus L. reuteri |
| Standard diet | No intervention | Astringent diet from baseline treatment up to 6 weeks or death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea toxicity
The diarrhea grade will be determined from 1 to 5 following the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. As shown below:
grade 1: Increase of < 4 stools per day over baseline; mild increase in ostomy output compared to baseline grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL.
grade 3: Increase of >= 7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL.
grade 4: Life-threatening consequences; urgent intervention indicated grade 5: Death
Measured: every two weeks, from first dose of TKI therapy up to six weeks.
Functional Assessment of Chronic Illness Therapy
This assessment will be evaluated with a specific scale for diarrhea (FACIT instrument), which consists of 11 items that assign a value of 0 to 4 for each one. Higher the score, the better quality of life related to diarrhea.
Measured: Every two weeks, from first dose of TKI therapy up to six weeks.
Secondary outcomes (3)
Grade of gastrointestinal toxicity
This outcome will be determined from grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for gastrointestinal disorders.
Measured: Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of health related quality of life (QoL)
The QoL of patients with cancer will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30 v3.0) instrument.
Measured: Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of quality of life (QoL) for lung cancer patients
The QoL for Lung Cancer patients will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-LC13) instrument.
Measured: Every two weeks, from first dose of TKI therapy up to six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Mar 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung Cancer With EGFR MutationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients with Non-Small Cell Lung Cancer and EGFR Mutation receiving first or second generation-TKI therapy.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar G Arrieta Rodriguez, M.D., M.Sc., Principal investigator, Instituto Nacional de Cancerología de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852990
- Sponsor's protocol ID
- CEI/1565/21 INCAN/CEI/0074/22
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Arrieta O, Nunez-Valencia C, Reynoso-Erazo L, Alvarado S, Flores-Estrada D, Angulo LP, Onate-Ocana LF. Health-related quality of life in patients with lung cancer: validation of the Mexican-Spanish version and association with prognosis of the EORTC QLQ-LC13 questionnaire. Lung Cancer. 2012 Jul;77(1):205-11. doi: 10.1016/j.lungcan.2012.02.005. Epub 2012 Mar 3.
PubMed 22387006Goldstraw P, Ball D, Jett JR, Le Chevalier T, Lim E, Nicholson AG, Shepherd FA. Non-small-cell lung cancer. Lancet. 2011 Nov 12;378(9804):1727-40. doi: 10.1016/S0140-6736(10)62101-0. Epub 2011 May 10.
PubMed 21565398Walters S, Maringe C, Coleman MP, Peake MD, Butler J, Young N, Bergstrom S, Hanna L, Jakobsen E, Kolbeck K, Sundstrom S, Engholm G, Gavin A, Gjerstorff ML, Hatcher J, Johannesen TB, Linklater KM, McGahan CE, Steward J, Tracey E, Turner D, Richards MA, Rachet B; ICBP Module 1 Working Group. Lung cancer survival and stage at diagnosis in Australia, Canada, Denmark, Norway, Sweden and the UK: a population-based study, 2004-2007. Thorax. 2013 Jun;68(6):551-64. doi: 10.1136/thoraxjnl-2012-202297. Epub 2013 Feb 11.
PubMed 23399908Secombe KR, Van Sebille YZA, Mayo BJ, Coller JK, Gibson RJ, Bowen JM. Diarrhea Induced by Small Molecule Tyrosine Kinase Inhibitors Compared With Chemotherapy: Potential Role of the Microbiome. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420928493. doi: 10.1177/1534735420928493.
PubMed 32493068Achamrah N, Dechelotte P, Coeffier M. Glutamine and the regulation of intestinal permeability: from bench to bedside. Curr Opin Clin Nutr Metab Care. 2017 Jan;20(1):86-91. doi: 10.1097/MCO.0000000000000339.
PubMed 27749689Sanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10.
PubMed 22489794Arrieta O, Michel Ortega RM, Villanueva-Rodriguez G, Serna-Thome MG, Flores-Estrada D, Diaz-Romero C, Rodriguez CM, Martinez L, Sanchez-Lara K. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study. BMC Cancer. 2010 Feb 21;10:50. doi: 10.1186/1471-2407-10-50.
PubMed 20170547
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05852990
- Acronym / sponsor ID
- CEI/1565/21 INCAN/CEI/0074/22
- Keywords
- Non-Small Cell Lung Cancer, EGFR mutation, Glutamine, Lactobacillus reuteri, standard-care diet
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 10 May 2023 (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.
This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy.
The main question it aims to answer is ¿What is the effect of glutamine plus L. reuteri added to an astringent diet in preventing diarrhea generated by TKI therapy?
Patients will receive an astringent diet supplemented with 10 grams of glutamine and L. reuteri (100 million CFU). Researchers will compare the Glutamine plus L. reuteri diet with a standard astringent diet to see if TKI therapy diarrhea is prevented.
Detailed description
Patients in the experimental group will receive two sachets of Glutapak-R every twelve hours for up to six weeks alongside treating physician-chosen EGFR therapy. Patients in the control group will receive a standard-of-care diet.
All patients will receive nutritional counseling every two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with Non-Small Cell Lung Cancer and EGFR Mutation receiving first or second generation-TKI therapy.
| Arm | Type | Receives |
|---|---|---|
| Intervention diet | Experimental | Combination Product: Glutamine plus L. reuteriAstringent diet supplemented with one sachet containing 10 grams of glutamine plus 100 million Colony Forming Units (CFU) of Lactobacillus reueri every 12 hours, from baseline treatment up to 6 weeks or death. |
| Standard diet | No intervention | –Astringent diet from baseline treatment up to 6 weeks or death. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both sexes
- ≥ 18 years old
- Pathologically confirmed diagnosis of NSCLC
- Stage IIIB - IV by the American Joint Committee of Cancer Version 8.
- Candidates to receive EGFR-TKI treatment (1st \& 2nd generation TKI)
Key exclusion criteria (7 listed)
- Patients who cannot attend the first protocol appointment.
- Treatment with other anti-cancer therapy
- Participating in other clinical trials in the former four weeks
- Any other serious condition or uncontrolled active infection, altered mental status or psychiatric disorder that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results.
- Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.
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 |
|---|---|---|
| Glutamine plus L. reuteriAlso: Glutapak-RGlutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death | Combination product | Intervention diet |
Primary outcome
Diarrhea toxicity
Time frame: every two weeks, from first dose of TKI therapy up to six weeks.
The diarrhea grade will be determined from 1 to 5 following the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. As shown below: grade 1: Increase of < 4 stools per day over baseline; mild increase in ostomy output compared to baseline grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL. grade 3: Increase of >= 7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL. grade 4: Life-threatening consequences; urgent intervention indicated grade 5: Death
Functional Assessment of Chronic Illness Therapy
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
This assessment will be evaluated with a specific scale for diarrhea (FACIT instrument), which consists of 11 items that assign a value of 0 to 4 for each one. Higher the score, the better quality of life related to diarrhea.
3 secondary outcomes
Grade of gastrointestinal toxicity
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of health related quality of life (QoL)
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of quality of life (QoL) for lung cancer patients
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
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 9 Apr 2026.
- Background: PubMed 22387006Arrieta O, Nunez-Valencia C, Reynoso-Erazo L, Alvarado S, Flores-Estrada D, Angulo LP, Onate-Ocana LF. Health-related quality of life in patients with lung cancer: validation of the Mexican-Spanish version and association with prognosis of the EORTC QLQ-LC13 questionnaire. Lung Cancer. 2012 Jul;77(1):205-11. doi: 10.1016/j.lungcan.2012.02.005. Epub 2012 Mar 3.
- Background: PubMed 21565398Goldstraw P, Ball D, Jett JR, Le Chevalier T, Lim E, Nicholson AG, Shepherd FA. Non-small-cell lung cancer. Lancet. 2011 Nov 12;378(9804):1727-40. doi: 10.1016/S0140-6736(10)62101-0. Epub 2011 May 10.
- Background: PubMed 23399908Walters S, Maringe C, Coleman MP, Peake MD, Butler J, Young N, Bergstrom S, Hanna L, Jakobsen E, Kolbeck K, Sundstrom S, Engholm G, Gavin A, Gjerstorff ML, Hatcher J, Johannesen TB, Linklater KM, McGahan CE, Steward J, Tracey E, Turner D, Richards MA, Rachet B; ICBP Module 1 Working Group. Lung cancer survival and stage at diagnosis in Australia, Canada, Denmark, Norway, Sweden and the UK: a population-based study, 2004-2007. Thorax. 2013 Jun;68(6):551-64. doi: 10.1136/thoraxjnl-2012-202297. Epub 2013 Feb 11.
- Background: PubMed 32493068Secombe KR, Van Sebille YZA, Mayo BJ, Coller JK, Gibson RJ, Bowen JM. Diarrhea Induced by Small Molecule Tyrosine Kinase Inhibitors Compared With Chemotherapy: Potential Role of the Microbiome. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420928493. doi: 10.1177/1534735420928493.
- Background: PubMed 27749689Achamrah N, Dechelotte P, Coeffier M. Glutamine and the regulation of intestinal permeability: from bench to bedside. Curr Opin Clin Nutr Metab Care. 2017 Jan;20(1):86-91. doi: 10.1097/MCO.0000000000000339.
- Background: PubMed 22489794Sanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10.
- Background: PubMed 20170547Arrieta O, Michel Ortega RM, Villanueva-Rodriguez G, Serna-Thome MG, Flores-Estrada D, Diaz-Romero C, Rodriguez CM, Martinez L, Sanchez-Lara K. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study. BMC Cancer. 2010 Feb 21;10:50. doi: 10.1186/1471-2407-10-50.
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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.
Oscar G Arrieta Rodriguez, M.D., M.Sc. principal investigator
Instituto Nacional de Cancerología de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glutamine plus L. reuteri in people with Non-Small Cell Lung Cancer With EGFR Mutation, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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 8 inclusion and 7 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 9 Apr 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Oscar G Arrieta Rodriguez, M.D., M.Sc. (556280400 ext. 711101, ogar@unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea toxicity (time frame: every two weeks, from first dose of TKI therapy up to six weeks.). The study lists 2 primary outcomes in all. 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 NCT05852990, which also lists 7 linked publications.
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 9 Apr 2026.