Immune-Marker Platform for Patients With Advanced Lung Cancer

NCT ID: NCT07150598

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-06-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role: collaborator

Universitätsklinikum Köln

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Martin Wermke

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Wermke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus, Dresden

Jürgen Wolf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik I für Innere Medizin, CIO, Universitätsklinikum Köln

Locations

Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Countries

Germany

Central Contacts

Martin Wermke, Prof. Dr.

Role: CONTACT

impalux-studie@ukdd.de

+49 351 458 16226

Facility Contacts

Jürgen Wolf, Prof. Dr.

Role: primary

lungenkrebs@uk-koeln.de

+49221 478 89050

Martin Wermke, Prof. Dr.

Role: primary

impalux-studie@ukdd.de

+49 351 458 16226

Other Identifiers

DRKS00037281

Identifier Type: OTHER

Identifier Source: secondary_id

BO ff (Multi)-EK-118032025

Identifier Type: -

Identifier Source: org_study_id