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.
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
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
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.
Cohort
Prospective
Not listed
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 %.
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 %.
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Technische Universität Dresden
Lead sponsor
Deutsche Krebshilfe e.V., Bonn (Germany)
Collaborator
Universitätsklinikum Köln
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
