View clinical trials related to Lung Neoplasms.
Filter by:This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radiation therapy (RT), for patients whose disease is inoperable. The method of delivering the RT in this study is image guided stereotactic ablative radiation therapy (IG-SABR). This method involves using imaging to ensure the radiation is being delivered to the correct location within the body and using higher than normal doses per treatment (fraction) to treat the lung cancer (NSCLC)/oligometastatic lung lesion. This study aims to determine its safety by looking at the number and severity of side effects. This study will deliver 8 treatments/fractions of RT with 7.5 Gy delivered in each fraction. To be eligible for this study the initial treatment plan for the patient must be shown to not fulfil certain criteria relating to doses to the tumour and surrounding normal tissue. This study has its own study specific criteria which must be adhered to. Translational sub-studies (optional) are open to patients in participating centres only. Patients will have the option to consent to participating in both translational studies or to neither.
Studies indicate that the majority of early-stage non-small cell lung cancer (NSCLC) patients find it important to be involved in treatment decision making. However, in a recent study it has been reported that about 40% of the participants experienced decision conflict and feel uninformed(1). The investigators therefore developed a patient decision aid (PDA) for stage I-II NSCLC patients, that informs and empowers patients to help decide between stereotactic radiotherapy (SBRT) and surgery.
The purpose of the study is to determine whether adding vorolanib to atezolizumab will improve the length of time that participants are cancer-free after receiving standard chemotherapy.
This phase II trial studies two questions in patients with stage III NSCLC: 1) does it improve cancer control to add the drug Durvalumab, a type of immunotherapy, earlier in the treatment course; and 2) by intensifying treatment with durvalumab, is it possible to avoid mediastinal radiation to decrease side effects, without decreasing cancer control?
PD-1/PD-L1 blockades have attracted much attention in the treatment of lung cancer, however only a small set of patients can benefit from this kind of immunotherapy. At present, the expression level of PD-L1 is the major factor to evaluate the prognosis，, which is highly dependent on the quality of tissue samples and detection methods.Therefore, finding predictive markers,especially based on liquid biopsy, to screen the patients who will benefit most from PD-1/PD-L1 blockades is an urgent issue in immunotherapy for lung cancer. Tumor autoantibodies, as immune response products of the immune system to tumor antigens, are of great significance in tumor diagnosis. Till now, the relationship between tumor autoantibodies and immunotherapy efficacy has not been reported. In this study, 200 non-small cell lung cancer patients will be enrolled with baseline serum tumor autoantibodies detection, then treated with PD-1 blockade. The purpose of this study is to explore the correlations of serum autoantibodies expression and efficacy of PD-1 inhibitor, so that to identify new markers for predicting the efficacy of PD-1/PD-L1 immunotherapy in non-small cell lung cancer.
Surgery is the first choice of treatment for early-stage primary pulmonary malignancies, but up to 15% of all patients, and 33% of patients greater than 75 years of age, are not surgical candidate's due to locally advanced disease, poor cardiopulmonary reserve and significant medical co-morbidities. Some patients are also unwilling to undergo surgery. This has prompted the development of alternatives to surgery so that local control of unresectable tumors can be achieved. Stereotactic body radiation therapy (SBRT) is currently an alternative therapy for these patients with 3-year survival rates of between 42 and 60%. SBRT has excellent local control rates and a favorable toxicity profile relative to other surgical and non-surgical therapies. Radiation pneumonitis (RP), amongst others, is one of the major toxicities which can limit the maximal radiation dose that can be safely delivered to thoracic tumors. Reported rates of SBRT induced RP requiring clinical intervention range from 0% to 29% and life-threatening toxicities have been reported in up to 12% of cases in various studies. The potential for toxicities from SBRT could limit the number of times a patient could be treated with SBRT for residual, recurrent or new pulmonary lesions over time. Following the first report of thermal ablation for lung malignancies in 2000, this modality has been used to treat primary and secondary malignancies and has emerged as an effective, low-cost, safe and repeatable alternative to SBRT for local tumour control. The most widely practised technique is radiofrequency ablation (RFA). Microwave ablation (MWA) is a relatively new therapy and offers all the advantages of RFA, but with significant additional advantages 3. These include reduced procedure times, lower complication rates, increased ablative temperatures, improved propagation of thermal energy particularly in the lung, improved efficacy in lesions that are in close proximity to blood vessels due to reduced heat-sink effect, and less procedure associated pain 2,3. Using high energy MWA to treat 87 pulmonary tumors, Egashira et al achieved a primary technical success rate of 94% and technique effectiveness of 98% at a median of 15 months. MWA is performed by Interventional Radiologists using CT guidance. The treatment is performed under general anaesthesia and is repeatable. Multiple lesions can be ablated in one treatment session. Patients can potentially be discharged the same day of treatment, if there are no adverse events. MWA is a relatively new treatment option that could be considered in situations where the patient is not a candidate for further treatment with surgery, SBRT or chemotherapy, or the patient declines the recommended standard available treatments. Objectives for Phase I: The primary objective for Phase I of this study will be to demonstrate the Safety of MWA performed for treatment of lung malignancy in patients not suitable for surgery, chemotherapy or SBRT. Primary objective (Safety): to determine the proportion of patients experiencing local adverse events at one week definitively related to the mwa procedure. Secondary objective (Feasibility): To determine the proportion of patients in whom technical success of MWA was achieved by assessing completion of ablation on CT at the time of the procedure, indicated by replacement of tumor by ground glass change (including a 5mm ablation zone in normal surrounding lung parenchyma). Objectives for Phase II Primary objective (Efficacy): To demonstrate efficacy by measuring the proportion of patients demonstrating absence of residual tumor on follow up CT at 1 month after MWA. Secondary objective: To determine the proportion of patients needing re-treatment for recurrent tumor at 1 month post MWA.
The vast majority of patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) NSCLC are managed with upfront surgery, followed by adjuvant chemotherapy. However, relapse rates remain high and are primarily due to distant, metastatic disease. Previous meta-analysis evaluating the use of neo-adjuvant chemotherapy and adjuvant chemotherapy demonstrate a similar impact on improved disease free survival (DFS) and overall survival (OS). The role of checkpoint inhibitors has been proven to be effective in the treatment of patients with advanced NSCLC, regardless of histology and PD-L1 expression. Results from trials evaluating the use of checkpoint inhibitors alone or in combination with chemotherapy in the neoadjuvant setting for early stage disease are promising. However, there are no trials evaluating the role of concomitant chemotherapy and checkpoint inhibitors in the adjuvant setting. In addition, emerging data supports the use of ctDNA as a promising biomarker for early detection of minimal residual disease and have indicated that the presence of detectable ctDNA after surgery for localized lung cancer is correlated with a 90-100% chance for disease recurrence. Therefore, we propose this current study assessing concomitant chemotherapy plus Atezolizumab in the adjuvant setting for patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) NSCLC who have detectable ctDNA after surgery. The clearance of ctDNA will serve as a surrogate for long term DFS and OS in this patient population.
Lung cancer is a global problem. Worldwide, 1.2 million people die of lung cancer each year. In Iraq, lung cancer is the most common malignancy after breast cancer and the leading cause of cancer-related death. Tobacco smoking plays a major role in lung cancer; it is reported in 85-90% of lung cancer patients yet environmental tobacco smoke, environmental and domestic air pollution, work-related risk factors, radon exposure, and viruses may also have an impact on lung cancer incidence rates. Early detection of the disease before patients develop symptoms considers the best way to improve patient outcomes. IT LUCAS is designed to evaluate the utility of low-dose computed tomography (LDCT) screening in early detection and management of lung cancer in high-risk people.
The unexpected onset of SARS-COV2 infection modified our practices, especially in routine medicine. In order to reverse the epidemic curve of severe cases and slow the spread of the infection, confinement was generalized in France from March 13, 2020.These restrictive measures were imposed on anyone with symptoms compatible with the infection, with the exception of dyspnea and other criteria of severity. March 12, 2020 is the pivotal date when the management of COVID came to interfere with medical and healthcare organizations. From this date, it is likely that some imaging or endoscopic exams have been de-scheduled for symptoms that are sometimes wrongly judged to be non-urgent and have seen their numbers drop dramatically.Otherwise, concerning lung cancer, preventive measures have been extremely strengthened. For instance, it is recommended to delay surgeries for localized tumors, to relieve or remove some chemotherapy or to delete radiotherapy sessions deemed non-essential. However, symptoms that may initially be attributed to viral infection, such as cough, fever, fatigue, or chest pain may be clinical indicators of early-stage Lung cancer. In addition, lung cancer is likely to make the patient more susceptible to pneumopathy, due to a weakened of immune response to viruses and bacteria. Consequently, as necessary as the restriction measures are, a risk of slowing down in the management of the Lung cancer pathology exists. The CBP-COVID Study intends to assess consequences of restrictive measures linked to the SARS-COV2 epidemic, by comparing clinical characteristics at diagnosis, treatment times and treatments, regarding to 2 distinct time periods identical to the calendar, but one in 2019, the other in 2020.
The introduction of maintenance immunotherapy with the anti PD-L1 inhibitor durvalumab opened a new therapeutic window for stage III NSCLC patients who achieve at least stable disease after chemo-radiation, as shown by the randomized phase 3 PACIFIC study. However, still half of the patients do progress at 12 months (up to 70% at 18 months). In this study, the investigators aim to test a non-invasive image-based approach, namely a "radiomics" platform, as a tool to define a higher or lower likelihood of response to chemo-radiation and durvalumab. For this purpose, we will retrospectively and prospectively collect and analyze a cohort of at least 70 stage III NSCLC patients treated with CT-RT followed by maintenance durvalumab.