
AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer...
Non Small Cell Lung CancerNeoepitopes4 moreThe goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response. A key challenge to be solved using the technology is to predict for each patient which neoepitopes are not only likely to bind to HLA or be presented on the tumor cell surface, but also will be recognized by the T-cell receptor and create the immunogenic response. The presence of such epitopes is required for immunotherapy by immune checkpoint inhibition to have an effect on the disease. Knowledge of those epitopes enables therapeutic strategies to boost the immune response by designing personalized cancer vaccines and adoptive cell therapies. The samples and data collected in this clinical study will be used for clinical validation of A.I.mmune technology. For all patients treated with immunotherapy (using anti-PD1 / anti-PDL1 and / or anti-CTLA-4 antibodies) peripheral blood samples (PBMC) and biopsy (FFPE) collection will be performed before treatment. Samples will be sequenced by next-generation sequencing platform. In parallel, the investigators will also collect samples of stool (one sample before the start of immunotherapy) and follow-up information of responses to treatment.

Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced /...
Locally Advanced/ Metastatic NSCLCVinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.

Pemetrexed/Carboplatin vs Vinorelbine/Carboplatin in Patients With Completely Resected Non-small...
Non-small Cell Lung CancerThe main purpose of this randomized phase II trial is to evaluate the clinical feasibility and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with vinorelbine/carboplatin in patients with completely resected non-small cell lung cancer (NSCLC).

A Retrospective Study of Biomarkers in Non-Small Cell Lung Cancer
Non Small Cell Lung CancerThe purpose of this study is: To characterize the types and frequency of molecular alterations to the epidermal growth factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell lung cancer To identify candidate biomarkers of importance in the EGFR and estrogen pathways Most, if not all, human malignancies including lung cancer are caused by somatic alterations of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene activation and tumour suppressor gene inactivation respectively. Little is known about the relationship between these oncogenes of the EGFR family and the recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and other sex hormones in lung cancer are warranted. A further understanding of the molecular indicators of lung cancer prognosis and treatment prediction would improve drug development and patient treatment selection. Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology and the National University Tissue Repository respectively. Clinico-pathological characteristics will be obtained from the case records, Pathology and Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4. Unstained slides from the paraffin-embedded tissue will be obtained and subjected to fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as previously described. For cases that have been snap-frozen, RNA will be extracted and EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3, AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The status of the tumor suppressor genes PTEN and C/EBPa will be analysed.

Association Between VEGF-C and miRNA and Clinical Non-small Cell Lung Cancer and Esophagus Squamous...
VEGFC Protein in SerumVEGFC Protein in Non Small Cell Lung Cancer3 moreLung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The main problem is lack of effective tool in early detection that accounts for the poor outcome of cancer. Clinically, over 80% of patients with cancer were at late stage when they were diagnosed. Therefore, it is important for us to find the biomarker that serve as the early prediction of cancer. The investigators have published that VEGFC over-expressed in non-small cell lung cancer. VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of lymphatic endothelial cells and enhances migration and invasion. Investigator found that VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer. MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21~23 nucleotides that function as post-transcriptional gene regulators. Recent studies indicated that certain microRNAs reduced in cancer patients. Therefore it is important to investigate whether specific microRNA changed in certain kinds of cancer patients.

The Utility and Cost-Effectiveness Analysis of 18F-FDG PETin Staging Potential Operable Non-Small...
Non Small Cell Lung CancerWe plan to conduct a prospective study: to evaluate the accuracy of PET in staging patients with potentially operable non-small cell lung cancer; to evaluate the percentage of futile thoracotomy after PET is introduced in the routine staging modalities for NSCLC patient; to establish a decision tree model based on choices between conventional imaging only and additional PET imaging to analyze their cost-effectiveness.

Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative...
NSCLC Stage IVEGFR T790M-negative2 moreThis study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.

Efficacy and Safety of Camrelizumab in Real-World Study
Non-small Cell Lung CancerThis observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.

ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS
Non-small Cell Lung Cancer Stage ICtDNA detection is a noninvasive detection method, and the second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .

Therapeutic Resistance Prediction of Tyrosine Kinase Inhibitors
Non-small Cell Lung CancerThe investigators propose a non-invasive prognostic tool for TKIs resistance in patients with stage IV EGFR-mutant non-small cell lung cancer (NSCLC) by computed tomography phenotypic features, which can be conveniently translated to facilitate the pre-therapy individualized management of EGFR TKIs in this disease.