Immune-Marker Platform for Patients With Advanced Lung Cancer

Primary Outcomes (2)

• 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 %.

  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 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 %.

  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.

Conditions