View clinical trials related to Non-Small Cell Lung Cancer.
Filter by:The current proposal is structured as a pilot trial to evaluate the impact of non-ablative SBRT (800 cGy X 3 fractions) as an immunomodulatory mechanism in patients with early stage NSCLC who are surgical candidates. Tumor, normal tissue and blood specimens will be analyzed for immunomodulatory changes including phenotypic changes in tumor cell surface marker expression, tumor and normal tissue microenvironment and gene expression profiles, serum/blood immune profile changes, and circulating tumor cell immunophenotypic and gene expression alterations. Published literature showed that cytotoxic doses of XRT may not elicit a clinically meaningful alteration in the immune profile. Further, studies using an animal model have concluded a fractionated regimen induces a greater abscopal effect than single dose radiation. Furthermore, research has shown a regimen of 800 cGy X 3 fractions yielded the most significant changes in the immune profile compared to 2000 cGy X 1 or 600 cGy X 5. The immune response within the tumor milieu is a complex dynamic process with an interplay among lymphocyte subsets, antigen presenting cells/dendritic cells, macrophages, and tumor cells. The interactions between the various components is orchestrated by a variety of extracellular and intracellular signaling pathways involving ligand and cell surface expression, cytokine release, and activation or inhibition of a variety of T cell subsets. In order to comprehensively define the immunomodulatory effect of three fractions of 800 cGy on the primary tumor, the investigators will analyze the following: tumor cell surface phenotype, tumor microenvironment immune profile and gene expression profile, T cell repertoire changes in tumor tissue and peripheral blood, and circulating tumor cell phenotype and gene expression profiles. Each of these components has been shown to be impacted by radiation in either a cell culture or animal model systems. By characterizing, quantitating and defining these changes related to three fractions of 800 cGy, it will directly provide important insights to inform rational uses of XRT and immunotherapy in the future.
Human microbes have been called "the second genome of humanity".On May 13,2016,the White House launched the National Microbiome Initiative (NMI), with an estimated investment of us $521 million, to elevate microbiome research to a national strategic status. The gut is the largest microecological environment in the human body. The research in the field of intestinal microbiome has become one of the most advanced and hot research directions in the scientific field of the world today. At present, more than 50 diseases have been found to be related to intestinal microbiome disorders. Pd-1 (programmed death receptor 1) is an important immunosuppressive molecule.It regulates the immune system and promotes tolerance by down-regulating the immune system's response to human cells and by suppressing T cell inflammatory activity. In the past, the research team and colleagues in related fields have found a strong correlation between Gut Microbiome and the efficacy of anti-PD-1 immunotherapy in cancer patients.This protects against autoimmune diseases, but it also prevents the immune system from killing cancer cells. As more and more scientific evidence shows that intervention of human intestinal flora may improve the efficacy of anti-PD-1 immunotherapy in tumor patients, intestinal flora, as the most effective way to intervene human intestinal flora, has been mentioned by many research institutions and international drug manufacturers in combination with anti-PD-1.Our previous study showed that the abundance of beneficial bacteria such as lactic acid bacteria, bifidobacteria and Akkermansia Muciniphila was significantly correlated with pD-1 inhibitor response, and regulating the intestinal flora content could improve the effect of PD-1 inhibitor on mouse tumors, indicating that microbial flora was involved in regulating cancer immunotherapy.
This phase I trial is designed in two parts. First as an open-label, dose escalation trial of MEM-288 monotherapy in which investigators aim to find the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Subjects with selected solid tumors including non-small cell lung cancer (NSCLC) who have a tumor lesion which is accessible for injection will undergo intratumoral injection of MEM-288. Following completion of the monotherapy study portion of the study, an expansion arm is designed to test MEM-288 with concurrent anti-PD-1 (nivolumab) therapy for patients with first relapsed or refractory advanced/metastatic NSCLC following front-line anti-PD-1/PD-L1 with or without concurrent chemotherapy. The study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 interferon (IFN) in injected tumors will provide a strong signal for dendritic cell (DC)-mediated T cell activation leading to generation of systemic anti-tumor T cell responses with broad specificity akin to what is observed in the abscopal effect. Further study rationale is the anti-tumor effect of MEM-288 will be enhanced by nivolumab by reversing T cell exhaustion.
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who have not been exposed to prior G12C inhibitor.
The purpose of this study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa), in combination with pembrolizumab in patients with previously treated NSCLC. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene, and is a systemic gene therapy. The study will be conducted in 2 phases, a dose escalation phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with pembrolizumab to determine the recommended Phase 2 dose (RP2D). Phase 2 will be comprised of a dose expansion portion and a randomized portion. In the dose expansion portion, patients will be enrolled and treated with quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab. In the randomized portion, patients will be randomized to receive either the investigational treatment of quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab or a control treatment of either docetaxel +/- ramucirumab or the investigator's treatment of choice.
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
This study is a single arm, open-label, intravenous infusion of Anti- Epidermal growth factor receptor (EGFR) Chimeric Antigen Receptor (CAR) T cells modified by C-X-C Chemokine receptor type 5 (CXCR 5) in patients with advanced adult non-small cell lung cancer (NSCLC).
Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.
The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.
This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.