View clinical trials related to Non-Small Cell Lung Cancer.
Filter by:The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment.
Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different therapy protocols is variable, with hypoxia known to be a major factor that negatively influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of modern radiation therapy strategies, such as intensity modulated radiation therapy (IMRT), might allow higher dose applications to the target volume, leading to improvement of therapy outcome. 18F-fluoromisonidazole dynamic positron emission tomography and computed tomography (18F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are attractive strategies for imaging tumor hypoxia. The HIL trial is a single centre pilot study combining multimodal hypoxia imaging with 18F-FMISO dPET-CT and functional MRI and intensity modulated radiation therapy (IMRT) in patients with inoperable stage III NSCLC. 15 patients are recruited in the study. All patients undergo serial 18F-FMISO dPET-CT and functional MRI before treatment, at week 5 of radiotherapy and 6 weeks post treatment. Radiation therapy is performed as inversely planned IMRT after four dimensional computed tomography (4D-CT) based target volume definition. Hypoxia imaging is not included in target volume definition or IMRT dose prescription. Objectives of the trial are to characterize the correlation of 18F-FMISO dPET-CT and functional MRI for tumor hypoxia imaging in NSCLC and evaluate possible effects of radiation therapy on tumor re-oxygenation. Further objectives include the generation of data regarding the prognostic value of 18F-FMISO dPET-CT and functional MRI for locoregional control, progression free survival and overall survival of NSCLC treated with IMRT, which will form the basis for larger clinical trials focusing on possible interactions between tumor oxygenation and radiation outcome.
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.
Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs and other agents. There is a factor called ISG15 which might help doctors better identify patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases. Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in cell growth, and it has been FDA approved for 17 years for another type of cancer.
The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.
This pilot, non-interventional, observational, Web-based, prospective cohort study is designed to collect self-reported safety and effectiveness and genetic data from subjects with locally recurrent breast cancer (BC) or metastatic breast cancer (MBC), metastatic colorectal cancer (MCRC), metastatic non-squamous non-small cell lung cancer (MNSCLC), recurrent glioblastoma (RGBM), or metastatic renal cell cancer (MRCC) in the United States who have been previously treated with Avastin (bevacizumab). The cohort will be composed of male and female subjects who have been diagnosed with locally recurrent BC or MBC, MCRC, MNSCLC, RGBM, or MRCC who have received treatment with bevacizumab in combination with chemotherapy, which started prior to or up to 31 December 2012. Participants will be self-referred to this study. They will be recruited online via a number of sources, including through the involvement of patient advocacy groups, social media tools, traditional media, physicians, and events to raise awareness of this study. After appropriate informed consent and authorization are obtained, data will be collected directly from subjects in an online survey. Participants will be contacted electronically to complete quarterly follow-up surveys. The follow-up period will be 1 year from responding to the baseline survey. DNA collection will be performed as part of this study. DNA will be extracted from saliva, which will be provided by the subject utilizing a collection kit sent to the participants for at-home use.
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Modern anti-cancer treatments are focused on development of molecular based therapies i.e. specific treatments targeted against underlying biological processes. There is still much to learn about the biology of cancer, especially in tumours such as colorectal and lung cancer where it is likely multiple heterogenous signaling pathways are responsible for progression of disease. This project aims to evaluate circulating tumour cells (CTCs) as a surrogate biomarker for tumour characteristics and to determine how they may used to identify new targets for therapeutic agents. Their use could be applied to diagnosis of cancer, prediction of response to therapies and prognosis, ultimately across a broad range of tumour types. Currently the only way to investigate molecular features of a cancer is through procurement of an invasive tumour biopsy that is often difficult to obtain, often results in insufficient material and is unpleasant for the patient. A blood-based test would provide a much more practical and patient friendly alternative. The enumeration and molecular characterisation of CTCs has the novel potential of being a "virtual biopsy" of the tumour and offers the opportunity for immediate therapeutic decisions (eg. if the tumour develops a therapy resistant genotype while on treatment). CTCs have been known to circulate in bloodstream of cancer patients for many years and are known to lead to cancer metastases. They have been very difficult to detect, up until recently, due to the complexity of the metastatic process and detecting relatively small numbers of CTCs amongst billions of red and white blood cells. However, technology has moved on dramatically in the last few years. The FDA approved CellSearch platform (Veridex, NJ) can isolate and enumerate CTCs based on the immunomagnetic capture of EpCAM (epithelial cell adhesion molecule) positive cells. Several studies have recently demonstrated the value of CTC enumeration in reflecting prognosis and predicting early response to systemic chemotherapy. For example, in a study comprising 456 patients with metastatic colorectal cancer starting a new line of therapy, patients with =3 CTCs per 7.5 ml blood at baseline had shorter progression free survival (PFS) and overall survival (OS) compared to those patients with < 3CTCs at baseline (PFS 4.5 versus 7.9 months P=0.0001; OS 8.5 versus 19.1 months P=0.0000 respectively). Overall survival for patients converting to or maintaining CTCs =3 within a few weeks of commencing systemic therapy remained worse than for those patients maintaining CTC counts < 3 per 7.5ml blood. Similar results have been reported in patients with breast and hormone refractory prostate cancer (HRPC). These studies have led to FDA approval of the CellSearch system as an adjunct to monitoring patients with these 3 tumour types. The CellSearch platform, however, does not allow for the downstream DNA analysis of captured cells and the ferroparticle-coated CTCs are non-viable. Furthermore, this platform is a multi-machine, multi-kit system that is laborious (typical 3-7 days turnover time), expensive (USD 650), and subject to operator variance. In this protocol, the investigators propose for the first time, an automated, fully quantitative system for isolation and enrichment of CTCs. The key differentiating feature of our novel CMOS system is the electrochemical identification and counting of tumour cells using a high density electrode array with associated electronics for addressing the electrodes. This leads to a standardized assay for tumour cells with a shorter turnover time and without the need of a skilled operator. This system also holds the potential for allowing the molecular characterization of CTCs. This study aims to enumerate CTCs using a novel CMOS technology in patients with metastatic cancer who are scheduled to receive palliative chemotherapy, and to correlate CTC number with clinical outcome. In Part I of the study, the investigators will recruit 10 patients with metastatic NSCLC and 10 patients with metastatic CRC in order to assess the feasibility of CTC enumeration in patients. In particular, the investigators aim to establish whether CTCs are detectable using the novel CMOS technology in patients with metastatic cancer. In Part II of the study, the investigators will recruit 21 patients with metastatic NSCLC and 89 patients with metastatic CRC in order to compare CTC counts as determined by the CMOS technology with CTC counts as determined by the CellSearch platform. Blood samples will be collected at a single time point prior to the start of palliative chemotherapy. CTC numbers will be correlated with clinical outcome in all evaluable patients. The investigators hypothesize that CTC enumeration by a novel CMOS technology is non-inferior to CTC enumeration by the CellSearch platform in patients with advanced solid malignancies.
Epidermal growth factor receptor-tyrosin kinase inhibitor (EGFR-TKI, Erlotinib) has demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer. But, their use is associated with dermatologic reactions of varying severity. Incidence of Erlotinib related skin effect (ERSE) was reported ~75% in NSCLC and pancreatic cancer phase III trials. Even though the dermatologic reactions could be a surrogated marker, it may be cause of dose modification. Also, it could give significant physical and psycho-social discomfort to patients. However, there is still a wide variety of drugs used- including, steroid, antibiotics, and vitamin D without any clear evidence based management recommendation. The role of epidermal growth factor (EGF) has been extensively investigated in normal and pathological wound healing. It is implicated in keratinocyte migration, fibroblast function and the formation of granulation tissue. The first growth factor to be isolated growth factor therapy has progressed into clinical practice in the treatment of wounds. Therefore, the investigators propose an epidermal growth factor ointment apply for patients with Erlotinib related skin effects.
The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.