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Table 4 Clinical studies for biomarkers under investigation for predicting response or determining prognosis of patient with NSCLC to treatment

From: Clinical potential of gene mutations in lung cancer

Study name Identifiera Purpose Biomarker(s)
The identification, validation, and implementation of prognostic and/or predictive biomarkers for adjuvant chemotherapy in early stage NSCLC NCT01595074 Evaluate biomarkers for predicting treatment response in samples from patients with early-stage NSCLC (IA–IIIA) previously treated with adjuvant chemotherapy 15 Gene prognostic and predictive mRNA signature
Adjuvant lung cancer enrichment marker identification and sequencing (ALCHEMIST) NCT02194738 Evaluate the use of genetic testing to screen patients with stage IB–IIIA NSCLC that will or have undergone surgery. EGFR, PIK3CA, PTEN, ALK, & other N/S
A study to assess the ability to initiate therapy in advanced NSCLC patients based on genetic analyses of tumor specimens NCT02178163 Evaluate use of genomic analysis of tissue samples from patients with reoccurred or stage IV NSCLC to select therapy treatment N/S
A study of predictive and prognostic markers in patients with NSCLC NCT00958555 Investigate predictive and prognostic markers from circulating tumor cells in blood and tumor for outcome after treatment for NSCLC Genes linked to genetic risk of NSCLC (N/S)
A pilot study to evaluate the predictive value of circulating tumor DNA for clinical outcome in patients with advanced head and neck and lung cancers NCT02245100 Evaluate predictive value of DNA from circulating tumor cells in patients with stage III–IV NSCLC to treatment N/S
A prospective study of plasma genotyping as a noninvasive biomarker for genotype-directed cancer care NCT02279004 Evaluate genotyping oncogenic mutations using blood samples from NSCLC patients to determine cancer genotype and patient response to therapy EGFR, KRAS, BRAF
Prognosis or predicting response
 Individualized 1st line chemotherapy based on BRCA1 and RRMI mRNA expression levels for advanced NSCLC NCT01424709 Compare survival rate of patients with advanced NSCLC based on gene expression compared to patients given gemcitabine/cisplatin RRM1 and BRCA1 mRNA
 Phase II ERCC1 and RRMI1-based adjuvant therapy trial in patients with stage I NSCLC NCT00792701 Compare survival of stage I NSCLC patients that have undergone surgery given chemotherapy based on gene expression compared to patients given gemcitabine/cisplatin ERCC1 & RRM1
 Pilot trial of docetaxel, gemcitabine, or pemetrexed single agent therapy with serial tumor specimen collection in patients with advanced NSCLC NCT02145078 Evaluate if levels of certain genes in tissue and blood samples are related to patient’s response to chemotherapy (stage IV NSCLC) and compare markers between CTCs, PBMCs, and tumor RRM1, TS, BRCA1 & other molecules N/S
  1. N/S biomarkers were not specified, BRAF v-raf murine sarcoma viral oncogene homolog B1, BRCA1 breast cancer susceptibility gene 1, CTC circulating tumor cells, EGFR epidermal growth factor receptor, ERCC1 excision repair cross complementing gene 1, KRAS v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog, PBMC peripheral blood mononuclear cells, PTEN phosphatase and tensin homolog, RRM1 ribonucleotide reductase M1, TS thymidylate synthase, NSCLC non-small cell lung cancer
  2. aDenotes http://www.clinicaltrials.gov identifier