Status:
NOT_YET_RECRUITING
Immune-Marker Platform for Patients With Advanced Lung Cancer
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
Universitätsklinikum Köln
Conditions:
NSCLC (Advanced Non-small Cell Lung Cancer)
NSCLC Stage IIIB~IV
Eligibility:
All Genders
18+ years
Brief 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 (NSCL...
Eligibility Criteria
Inclusion
- 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
- Willing and able to undergo re-biopsy 6 weeks after start of immune(chemo)therapy
- Cohort B:
- Any line of progression after firstline immune(chemo)therapy
- Sufficient tumor material obtained after progression on most recent line of treatment available or willing and able to undergo re-biopsy prior to next line treatment
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07150598
Start Date
September 1 2025
End Date
June 1 2027
Last Update
September 8 2025
Active Locations (2)
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1
Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln
Cologne, North Rhine-Westphalia, Germany, 50937
2
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany, 01307