Immune-Marker Platform for Patients With Advanced Lung Cancer

Not yet recruiting

• Conditions: NSCLC (Advanced Non-small Cell Lung Cancer); NSCLC Stage IIIB~IV; NSCLC Non-small Cell Lung Cancer

• Registration Number: NCT07150598
• Lead Sponsor: Technische Universität Dresden

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 (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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-08
• Primary Completion: 2027-03-31
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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
• 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 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
General technical success rate for multiplex immunofluorescence staining per biopsy	From enrollment until completion of all planned biopsy time points (baseline, 6 weeks after start of immunochemotherapy, and at each progression or therapy line change), up to approximately 24 months.	defined as a staining, which is: 1. considered evaluable by a trained pathologist according to the HE-, and multiplex-stained overview; 2. PanCK positive; 3. for which negative control and positive control stained in the same run are negative and positive, respectively.; Estimated at 60 %.
General success rate for the 3'RNA-Sequencing Approach per biopsy	From enrollment until completion of all planned biopsy time points (baseline, 6 weeks after start of immunochemotherapy, and at each progression or therapy line change), up to approximately 24 months.	defined as; 1. successful 3'RNA-isolation and -sequencing,; 2. keratin 18 (KRT18) expression is clearly detected above background, e.g. above a 5 Counts per million (CPM) cutoff and; 3. is considered evaluable by trained molecular biologist according to the sequencing results.; For 3'RNA-Seq, gene-specific expression distributions will be used to calibrate CPM, ranks, or similar metric cutoffs to define positivity/negativity.; Estimated at 60 %.

Trial Locations

Locations (2)

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln; 🇩🇪 Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Saxony, Germany