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. 2021 Aug 21;22(16):9030. doi: 10.3390/ijms22169030

Table 1.

Ongoing clinical trials investigating the genetic background of resistance to immunotherapy in lung cancer patients.

Clinical Trial ID Primary Outcome Measures Intervention/Treatment
NCT04203095 Correlation analysis between the ICIs resistance and CIN. Diagnostic test: the level CIN in plasma cfDNA.
Anti-PD-1 antibody treatment.
NCT04300062 Molecular mechanism involving the progression of NSCLC and SCLC Re-biopsy at the moment of cancer progression.
Immunotherapy.
NCT03512847 Concordance between specific gene profiles and treatment outcomes. Differences in molecular profiles pre- and post-treatment. Quantification of cfDNA during treatment linked to treatment outcome. Comprehensive molecular profiling and whole exome sequencing (WES) of cfDNA.
Immunotherapy/chemotherapy.
NCT04807114 Identification and comparison the percentages of immune cell subtypes present in tumors from responding vs. non-responding the patients before start of ICIs therapy. Tumor biopsies from patients before start of treatment.
Anti-PD-1 monotherapy or combination of anti-PD-1 therapy and chemotherapy.
5 Identification of actionable mutations and intratumor heterogeneity in NSCLC patients with EGFR or HER2 genes mutations and relapse after afatinib treatment. Qualification to different treatment regimens and measurement of therapy effectiveness (ORR, PFS) Biopsy sample at the time of NSCLC relapse.
Arm 1: Patients without an actionable mutation—atezolizumab monotherapy or in combination with chemotherapy;
Arm 2: Patients with BRAF V600 mutation—vemurafenib;
Arm 3: Patients with ALK or RET genes rearrangement—alectinib;
Arm 4: HER2 gene amplification—trastuzumab emtansine.
5 Correlations between specific genes mutations, immune microenvironment and ORR as well as PFS in patients received immunotherapy. Sequencing of DNA from FFPE tissue and whole blood. IHC analysis of immune microenvironment.
Anti-PD-1 or anti-PD-L1 antibody treatment.