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

Not Applicable

• Conditions: ocally advanced or metastatic non-small cell lung cancer; Cancer; Malignant neoplasm of bronchus and lung

• Registration Number: ISRCTN98848959
• Lead Sponsor: Instituto de Salud Carlos III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-17
• Last Update Posted: 16 January 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br><br> Added 12/08/2020:<br> 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).<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Fecal gut microbiome measured using V2-V4 r16S RNA and/or next generation sequencing platform (NGS)<br> 3. Fecal metabolome measured using NMR/LC-MS/GC-MS<br> 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<br> 5. Inflammation and oxidation parameters measured using commercial ELISA methods and/or multiplexing<br> 6. Dietary intake measured using a validated food-frequency questionnaire<br> 7. Antibiotic use measured using self-report<br> 8. Probiotic exposure measured using self-report<br> Measured at baseline and 12 weeks<br>