Immune-Marker Platform for Patients With Advanced Lung Cancer (IMPALUX)

Technische Universität Dresden

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07150598

BO ff (Multi)-EK-118032025

DRKS00037281 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Kohort A

Description:

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

Description:

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.