NSCLC (Advanced Non-small Cell Lung Cancer)IMPALUXNCT07150598
Immune-Marker Platform for Patients With Advanced Lung Cancer
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and NSCLC Stage IIIB~IV, run by Technische Universität Dresden at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC Stage IIIB~IV, NSCLC Non-small Cell Lung Cancer
- How many people
- 500 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Sep 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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%)
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Köln
Cologne, North Rhine-Westphalia, 50937
Jürgen Wolf, Prof. Dr., +49221 478 89050, lungenkrebs@uk-koeln.de
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Martin Wermke, Prof. Dr., +49 351 458 16226, impalux-studie@ukdd.de
About this study
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:
Read more
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General technical success rate for multiplex immunofluorescence staining per biopsy
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 %.
Measured: 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
- 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 %.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Universitätsklinikum Köln
- Responsible party
- Principal investigator, Dr. med. Martin Wermke, Technische Universität Dresden
- Investigators
- Martin Wermke, Prof. Dr., Principal investigator, Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus, DresdenJürgen Wolf, Prof. Dr., Principal investigator, Klinik I für Innere Medizin, CIO, Universitätsklinikum Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150598
- Sponsor's protocol ID
- BO ff (Multi)-EK-118032025
- Other IDs
- DRKS00037281
- Acronym
- IMPALUX
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune-Marker Platform for Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT07150598
- Acronym / sponsor ID
- IMPALUX / BO ff (Multi)-EK-118032025
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Universitätsklinikum Köln
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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%)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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
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 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 %.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Wermke, Prof. Dr. principal investigator
Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus, Dresden
Jürgen Wolf, Prof. Dr. principal investigator
Klinik I für Innere Medizin, CIO, Universitätsklinikum Köln
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and NSCLC Stage IIIB~IV, run by Technische Universität Dresden at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Wermke, Prof. Dr. (+49 351 458 16226, impalux-studie@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.