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Immune-Marker Platform for Patients With Advanced Lung Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

Immune-Marker Platform for Patients With Advanced Lung Cancer

NCT07150598•Technische Universität Dresden

Summary

The goal of this observational study is to better understand how the immune system and certain tumor markers are linked to treatment response in patients with advanced non-small cell lung cancer (NSCLC) who receive immunochemotherapy. The investigators aim to answer the following questions: * Can the investigators successfully analyze immune markers and gene activity from small tumor samples (biopsies)? * Are these markers connected to how well patients respond to immunochemotherapy and how their disease progresses? What will participants do? * Provide tumor tissue samples (biopsies) at key points: before treatment, about 6 weeks after starting immunochemotherapy, and if the cancer grows or treatment changes. * Allow their tumor samples to be analyzed in the lab using advanced techniques to measure immune and genetic markers. * Share clinical information (such as treatment response and disease progression) so investigators can study how it relates to these markers. This study does not test a new drug or treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For all:
•Written informed consent of the patient
•Consent of participation in the national Network for Genomic Medicine in Lung Cancer (nNGM)
•Advanced lung cancer with non-curative treatment option (NSCLC)
•No targetable driver mutation detected, defined as no targetable drive mutation in ALK, EGFR, BRAF, HER2, MET, NTRK, RET, ROS1
•PD-L1 expression on tumor cells (TPS \< 50%)
•Cohort A:
•Previously untreated NSCLC without curative treatment options
•Sufficient pre-treatment tumor material available for the planned analyses or consenting and able to undergo additional pretreatment biopsy
•Scheduled to undergo immune(chemo)therapy
+4 more criteria

Exclusion Criteria

•Any condition representing an unjustified risk for obtaining an additional biopsy sample (if needed) in the view of the investigator
•Incapability of understanding the purpose and possible consequences of the trial
•Substance abuse, medical, psychological or social conditions that may interfere with the subject's cooperation with the requirements of the trial or evaluation of the study results

Locations (2)

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Key Dates

Start Date

September 1, 2025

Primary Completion Date

March 31, 2027

Completion Date

June 1, 2027

Last Updated

September 8, 2025

Enrollment

500

ESTIMATED participants

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)NSCLC Stage IIIB~IVNSCLC Non-small Cell Lung Cancer

Contacts

Martin Wermke, Prof. Dr.

CONTACT

+49 351 458 16226 impalux-studie@ukdd.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immune-Marker Platform for Patients With Advanced Lung Cancer

Inclusion Criteria

Exclusion Criteria

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