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Non-Small Cell Lung Cancer clinical trials

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NCT ID: NCT01167530 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer

RAD001
Start date: March 2008
Phase: Phase 1
Study type: Interventional

The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung cancer. First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of the study:RAD001 (everolimus) will be administered per os every day one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1, D8, every 21 days.

NCT ID: NCT01158170 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

Start date: June 2010
Phase: Phase 3
Study type: Interventional

RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer

NCT ID: NCT01158144 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Concurrent Endostar, Paclitaxel/Carboplatin and Radiotherapy for Locally Advanced Non-small Cell Lung (RT0902)

Start date: October 2009
Phase: Phase 2
Study type: Interventional

Concomitant chemoradiotherapy is the standard treatment of locally advanced, non-resectable, non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still controversial. The purpose of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Endostar (Recombinant Human Endostatin), Paclitaxel/Carboplatin and radiotherapy for LA-NSCLC, and also assess its impact on patient Quality of Life (QoL) and progression-free survival (PFS).

NCT ID: NCT01130571 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Establishment and Characterization of Patient-Derived Non-Small Cell Lung Cancer Xenografts and Cell Cultures

Start date: September 2011
Phase: N/A
Study type: Observational

Xenografts and cell cultures provide sufficient material for analyses at the protein, RNA and DNA level. Patient derived NSCLC xenografts and cell lines are available but none however are Asian in origin. Given the emerging evidence to suggest inter-ethnic differences in NSCLC biology, new models of preclinical drug evaluation should be designed and validated using Asian tumors. Furthermore, such models will allow studies of biological mechanisms of sensitivity and/or resistance and also the study of dynamic regulations under standardized conditions in the Asian context.

NCT ID: NCT01100840 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Retrospective Study of Biomarkers in Non-Small Cell Lung Cancer

Start date: April 2009
Phase: N/A
Study type: Observational

The purpose of this study is: 1. 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 2. 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.

NCT ID: NCT01091376 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

RT0901
Start date: January 2010
Phase: Phase 2
Study type: Interventional

Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

NCT ID: NCT01054482 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

Start date: February 2007
Phase: Phase 2
Study type: Interventional

This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.

NCT ID: NCT01051362 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Pegylated Liposomal Doxorubicin and Carboplatin as First Line Treatment for Patients With Advanced Non-small Cell Lung Cancer

Start date: February 2006
Phase: Phase 2
Study type: Interventional

This Phase II study is to explore the efficacy and toxicity of Pegylated liposomal doxorubicin and Carboplatin in patients with previously untreated non-small cell lung cancer (NSCLC) not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 48 patients (including a 10% rate for inevaluable patients).

NCT ID: NCT01019798 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Sunitinib shows anti-tumor activity in a variety of human non-small cell lung tumor ex vivo models. Many Phases II and III clinical trials of sunitinib in several solid tumors are completed or still ongoing. So far, the efficacy of sunitinb has been confirmed by the phase III trial for imatinib-resistance or intolerance advanced gastrointestinal stromal tumor patients. And sutent was approved to effective by two phase II trials in advanced renal cell carcinoma patients after failure of immunotherapies, and one phase III trial in treatment-naive advanced renal carcinoma patients. Sunitinib (SUTENT ®) has been approved by U.S. Food and Drug Administration (FDA) for the treatment of advanced renal carcinoma patients and in gastrointestinal stromal tumor patients who are intolerant or progressed after imatinib mesylate. European Medicines Agency (EMEA) conditionally granted the marketing approval for the treatment of metastatic renal carcinoma patients after failure of immunotherapy. A phase II trial (A6181040 study) on non-small cell lung cancer patients treated with sunitinib alone showed anti-tumor activity. In 63 enrolled patients treated with 4/2 schedule (4 weeks treatment, then two weeks interruption), 7 patients are confirmed partial response (overall response rate, 11%), and median progress-free time is 14.3 weeks. Presently, a phase III study is underway on non-small cell lung cancer patients followed by and now is under recruiting. Non-small cell lung cancer cells often over-express vascular endothelial growth factor (VEGF) receptors. Besides, the expression of the VEGF ligands is also correlated with increased tumor angiogenesis, as well as shortened survival time. One study treated with VEGF-directed monoclonal antibody (bevacizumab) and VEGFR and platelet-derived growth factor receptor (PDGFR) small molecule inhibitors (sunitinib) showed that some non-small cell lung cancer patients are with anti-tumor activity. The chemotherapy drugs, such as docetaxel and platinum-based compounds, were with evidence that they have direct cytotoxicity to cancer cells. Therefore, the investigators are paying attention to the efficacy of combining sunitinib and conventional chemotherapy in this study. The study is designed as first line of salvage therapy on metastatic or unresectable non-small cell lung cancer patients. The main goals of this study is to evaluate the overall response rate (ORR) and duration of response (DR) of sunitinib in combinational with docetaxel and cisplatin in chemotherapy-naive advanced or metastatic non-small cell lung cancer patients.

NCT ID: NCT01003522 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer

RESTORE-AIR
Start date: September 2008
Phase: Phase 3
Study type: Interventional

To investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.