Immune-Marker Platform for Patients With Advanced Lung Cancer

NCT07150598 | Not Yet Recruiting

• 2 other identifiers: BO ff (Multi)-EK-118032025DRKS00037281
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Non-Small Cell Lung Cancer; NSCLC; Immunochemotherapy; Multiplex Immunofluorescence; 3'-RNA Sequencing; Prospective Observational Study; Tumor Microenvironment; Therapy Response; Precision Oncology

Outcome Measures

Primary Outcomes (2)

• General technical success rate for multiplex immunofluorescence staining per biopsy

  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 %.

  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.

• General success rate for the 3'RNA-Sequencing Approach per biopsy

  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 %.

  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.

Study Arms (2)

Kohort A

Patients with advanced non-small cell lung cancer (NSCLC) who undergo tumor biopsy at initial diagnosis and a second biopsy approximately 6 weeks after starting standard-of-care immunochemotherapy. Biospecimens will be analyzed using multiplex immunofluorescence and 3'-RNA sequencing to study immune and tumor-associated biomarkers.

Kohort B

Patients with advanced NSCLC who undergo tumor biopsy at the time of disease progression or therapy line change while receiving standard-of-care immunochemotherapy. Biospecimens will be analyzed using multiplex immunofluorescence and 3'-RNA sequencing to study immune and tumor-associated biomarkers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adult patients (≥18 years) with histologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) who are initiating or receiving standard-of-care immunochemotherapy. Eligible participants must be able to provide tumor biopsy material at predefined time points (baseline, 6 weeks after treatment start, and/or at progression or therapy line change). Both male and female patients will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator
• Universitätsklinikum Köln: collaborator

Study Sites (2)

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study will retain tumor biopsy specimens from patients with advanced non-small cell lung cancer (NSCLC). The samples include: Formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks or slides suitable for multiplex immunofluorescence staining and 3'-RNA sequencing analysis.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martin Wermke, Prof. Dr.

  Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus, Dresden

  PRINCIPAL INVESTIGATOR

• Jürgen Wolf, Prof. Dr.

  Klinik I für Innere Medizin, CIO, Universitätsklinikum Köln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Wermke, Prof. Dr.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)