Measuring small molecules (metabolites) in blood and urine that predict the response to immunotherapy in lung cancer patients

Metabolomic profiles in blood and urine as predictors of response to immunotherapy in lung cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN98848959

Enrollment

180

Registered

2020-07-17

Start date

2020-09-01

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic non-small cell lung cancer Cancer Malignant neoplasm of bronchus and lung

Interventions

First-line treatments with immunotherapy exclusively (those whose tumours express more than 50% of PDL1) or immunotherapy combined with chemotherapy (expression of PDL1 between 1 and 49%), and second-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than 18 years with stage III and IV NSCLC candidates for immunotherapy treatment

Exclusion criteria

Exclusion criteria: 1. Patients with another primary malignancy diagnosed in the previous 5 years (except for cervical carcinoma in situ and non-melanoma skin cancer) 2. Patients with tumours expressing actionable mutations in EGFR, ALK or ROS1 3. Patients with stage IV severe kidney disease (creatinine clearance < 30 ml/min) 4. Patients with severe liver disease (hepatitis, cirrhosis) 5. Patients with low Performance Status (ECOG 3-4) 6. Patients who refuse to sign the informed consent 7. Any previous systemic immunotherapeutic treatment will also make the patient ineligible for the study

Design outcomes

Primary

Measure	Time frame
Metabolites in blood and urine will be measured using targeted and untargeted approaches, and 1H NMR, LC-MS and GC-MS analytical techniques at baseline and 12 weeks Added 12/08/2020: The first evaluation of the response to immunotherapy will be carried out at 9-12 weeks of treatment with computed tomography scan and following the guidelines for the Immune Response Evaluation Criteria in Solid Tumours (iRECIST) and then every 3 months or at the time when there is suspicion of progression, and classified according to disease control (complete response, partial response, and stable disease) and progressive response (non-response).	—

Measure

Time frame

Metabolites in blood and urine will be measured using targeted and untargeted approaches, and 1H NMR, LC-MS and GC-MS analytical techniques at baseline and 12 weeks Added 12/08/2020: The first evaluation of the response to immunotherapy will be carried out at 9-12 weeks of treatment with computed tomography scan and following the guidelines for the Immune Response Evaluation Criteria in Solid Tumours (iRECIST) and then every 3 months or at the time when there is suspicion of progression, and classified according to disease control (complete response, partial response, and stable disease) and progressive response (non-response).

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Secondary

Measure	Time frame
1. Toxicity assessment reflected in the medical history, classifying it by affected organ and by degree of severity (1-4) based on ESMO clinical practice guidelines, performed at 12 weeks 2. Fecal gut microbiome measured using V2-V4 r16S RNA and/or next generation sequencing platform (NGS) 3. Fecal metabolome measured using NMR/LC-MS/GC-MS 4. Epigenetic tags (i.e. miRNAs, long ncRNA, telomeres, DNA methylation) measured using qPCR arrays for miRNAs and lncRNA, Luminex-based assay for telomere length, pyrosequencing for DNA methylation 5. Inflammation and oxidation parameters measured using commercial ELISA methods and/or multiplexing 6. Dietary intake measured using a validated food-frequency questionnaire 7. Antibiotic use measured using self-report 8. Probiotic exposure measured using self-report Measured at baseline and 12 weeks	—

Measure

Time frame

1. Toxicity assessment reflected in the medical history, classifying it by affected organ and by degree of severity (1-4) based on ESMO clinical practice guidelines, performed at 12 weeks 2. Fecal gut microbiome measured using V2-V4 r16S RNA and/or next generation sequencing platform (NGS) 3. Fecal metabolome measured using NMR/LC-MS/GC-MS 4. Epigenetic tags (i.e. miRNAs, long ncRNA, telomeres, DNA methylation) measured using qPCR arrays for miRNAs and lncRNA, Luminex-based assay for telomere length, pyrosequencing for DNA methylation 5. Inflammation and oxidation parameters measured using commercial ELISA methods and/or multiplexing 6. Dietary intake measured using a validated food-frequency questionnaire 7. Antibiotic use measured using self-report 8. Probiotic exposure measured using self-report Measured at baseline and 12 weeks

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026