Table 2.
Overview of ongoing clinical trials of liquid biopsy techniques in NSCLC undergoing immunotherapy.
| Clinical Trial Name, Number | Condition(s) | Sample Size | Assessments | Aim of Liquid Biopsy Analysis |
|---|---|---|---|---|
| TRACELib002, NCT04566432 | Treatment naïve Stage IIIB or Stage IV NSCLC |
n = 250 | Tissue biopsy and ctDNA liquid biopsy | the evolution of ctDNA mutation profile during treatment |
| NCT04490564 | HNSCC, NSCLC, or melanoma assigned to receive PD1 inhibitor | n = 185 | Tissue biopsy and PD-L1 CTCs | Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples |
| NCT03512847 | Metastatic NSCLC assigned for immunotherapy or chemotherapy | n = 150 | Tissue biopsy and longitudinal blood samples for ctDNA | Predictive gene profiles; resistance mechanisms toward chemotherapy and immunotherapy; ctDNA as a dynamic biomarker |
| NCT04636047 | Immunotherapy- naïve NSCLC | n = 450 | Blood samples analyzed by NGS CGP panel for mutations with sensitivity/resistance to targeted therapies, bTMB, HLA. | PFS, bTMB |
| K20-188, NCT04372732 | NSCLC PD-L1 expression ≥1% before anti-PD1 treatment | n = 200 | Tumor autoantibodies on blood samples | Correlation of tumor autoantibodies and PFS/ORR of PD-1 blockade treatment. |
| NCT03360630 * | Advanced NSCLC treated with anti-PD1 with or without DC-CIK immunotherapy | n = 60 | ctDNA on blood samples | Correlations of ctDNA with clinical outcomes * |
Abbreviations: bTMB, blood tumor mutational burden; CTC, circulating tumor cells; ctDNA, circulating tumor DNA; DC-CIK, dendritic cell-cytokine induced killer cell; HLA, human leukocyte antigen; HNSCC, head and neck squamous cell carcinoma; NGS CGP, next generation sequencing comprehensive genomic profile; NSCLC, non-small cell lung cancer; ORR, objective response rate; PD-1, programmed cell death protein 1; PD-L1, programmed cell death protein ligand 1; pExo, plasma exosomes; PFS, progression free survival. * randomized clinical trial o compared the clinical effects and safety of immunotherapy with dendritic cells and cytokine-induced killer cells administered with anti-PD-1 antibody in advanced NSCLC; among study’s outcome measures: to investigate the relationship of ctDNA with clinical outcomes.