Table 4.
Clinical studies for biomarkers under investigation for predicting response or determining prognosis of patient with NSCLC to treatment
| 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 |
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
aDenotes http://www.clinicaltrials.gov identifier