Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Can… (NCT07637474) | Clinical Trial Compass
RecruitingNot Applicable
Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients
Italy150 participantsStarted 2024-07-24
Plain-language summary
Prospective, biological, observational study involving the collection and use of samples from patients suffering from NSCLC lung cancer, aimed at comparing the molecular profile related to metabolism among subjects with response or resistance to checkpoint inhibitors immune system (ICI), in order to contribute to define response biomarkers and new molecular pathways as therapeutic targets combine with ICI to overcome resistance.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years
* Histological diagnosis of advanced stage NSCLC
* Histotype adenocarcinoma and squamous carcinoma
* ECOG PS \<2
* Known PDL-1 stage
* Measurable disease
* Availability of tumor tissue
* No evidence of molecular drivers
* Written informed consent (to the study and data processing)
For the second cohort in addition to the precedents it is included
* Diagnosis of limited or locally advanced NSCLC deemed resectable
For the third cohort in addition to the precedents it is included
* patients candidates for surgery for non-small cell lung cancer
Exclusion Criteria:
* Contraindications to immunotherapy
* Unavailability of tumor tissue
* Histotype with neuroendocrine or mixed component
For the second cohort
* Contraindication to immunotherapy
* Histotype with neuroendocrine or mixed component
* Locally advanced disease candidate for concomitant chemo-radiotherapy treatment
For the third cohort
* previously treated patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how immune metabolism dysregulation affects how well anti-PD-1/PD-L1 treatments work in NSCLC — could understanding my own immune metabolism profile actually change which treatment my doctor recommends for me?
2Since this trial is listed as Phase NA and is focused on measuring overall survival, is this an observational or biomarker study rather than one testing a new drug, and what would actually be different about my care if I participated versus just receiving standard treatment?
3The trial is currently recruiting — what would my time commitment look like, and would I need extra blood draws, biopsies, or follow-up visits beyond what my normal NSCLC treatment would require?
4Given that the primary outcome being measured is overall survival, how long would I need to stay enrolled for my data to be meaningful, and what happens to my participation if my treatment plan changes?
5Are there already approved anti-PD-1 or PD-L1 therapies that might be the right next step for me regardless of this trial, and would joining this study in any way delay or limit access to those standard options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.