Immune-Marker Platform for Patients With Advanced Lung Cancer

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.

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Key information

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC Non-small Cell Lung Cancer NSCLC Stage IIIB~IV Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

General technical success rate for multiplex immunofluorescence staining per biopsy

Time frame: 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:
- considered evaluable by a trained pathologist according to the HE-, and multiplex-stained overview
- PanCK positive
- 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

Time frame: 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
- successful 3'RNA-isolation and -sequencing,
- keratin 18 (KRT18) expression is clearly detected above background, e.g. above a 5 Counts per million (CPM) cutoff and
- 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 %.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Wermke, Prof. Dr.

CONTACT

[email protected]

+49 351 458 16226

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)
Universitätsklinikum Köln

Registry information

Acronym: IMPALUX

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 2, 2025
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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