NCT07150598Not yet recruiting
Immune-Marker Platform for Patients With Advanced Lung Cancer
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 25 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Technische Universität Dresden
- Diseases
- Lung cancer
- NCT number
- NCT07150598
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Sept 2025 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition representing an unjustified risk for obtaining an additional biopsy sample (if needed) in the view of the investigator
- 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
Other
- Incapability of understanding the purpose and possible consequences of the trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitätsklinikum Carl Gustav Carus Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.