View clinical trials related to Non-Small Cell Lung Cancer.
Filter by:ADOPT-LUNG is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.
Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion.
The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings.
In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations.
A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.
'1. Objective - Primary objective - Median Intracranial Progression-free survival(icPFS) as defined by RANO(Response Assessment in Neuro-Oncology) criteria - Secondary objective - Progression free survival(PFS) as defined by RECIST 1.1 - Median Intracranial progression free survival(icPFS) as defined by RECIST 1.1 - Intracranial objective response rate(icORR) as defined by RECIST 1.1 - Overall response rate(ORR) as defined by RECIST 1.1 - Duration of response(DoR) as defined by RECIST 1.1 - Disease control rate (DCR) defined by RECIST 1.1 - Overall survival (OS) ; The time from the date of inital IP administration to death due to any cause - Pattern of Progression ; Site of next progression - Safety objective - To evaluate the safety and tolerability of Trastuzumab deruxtecan.(AEs/SAEs, Vital signs, Collection of clinical chemistry/haematology parameters, ECGs) 2. Exploratory Purpose - To identify mechanisms of adaptive resistance using Guardant 360 panel. To conduct NGS using Guardant 360 panel in serial plasma collection before treatment and at the time of progression. - To identify the profiling of interstitial lung disease (ILD) after treatment of T-DXd. To perform the baseline and follow-up PFT. To perform high-resolution chest CT to evaluate for ILD by radiologic expert. To evaluate cytokine level in serially collected plasma (every 6 weeks for the first 24 weeks and then every 12 weeks). The investigators recommend doing one HRCT at baseline and a second one in the event of ILD. 3. Background Human epidermal growth factor receptor 2 (HER2, ERBB2)-activating mutations occur in 2% of lung cancers as a distinct molecular target. HER2-targeted therapy is standard of care for HER2-mutation positive non-small cell lung cancer (NSCLC). Trastuzumab deruxtecan (T-DXd, DS-8201, Enhertu) is a novel antibody drug conjugate that is comprised of 3 components: a humanized anti-HER2 IgG1 monoclonal antibody with the same amino acid sequence as trastuzumab; a topoisomerase I inhibitor payload, an exatecan derivative; and a tetrapeptide-based cleavable linker. Recently, T-DXd induced a confirmed objective response rate (ORR) of almost 61% and a durable benefit in heavily pre-treated patients with advanced HER2-positive breast cancer, according to results from the phase II DESTINY-Breast01 trial. In addition, the DESTINY-Gastric trial showed the superiority of T-DXd compared with standard chemotherapy in terms of response rate and progression-free and overall survival in this setting. Altogether, T-DXd received breakthrough therapy designation and orphan drug designation in gastric cancer, and approval for the treatment of advanced HER2-positive breast cancer. Recently, T-DXd showed durable systemic disease control along with CNS response. Ongoing trials are assessing the activity of T-DXd in patients with breast cancer and active brain metastases. T-DXd has been approved in the US for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 mutations, as detected by a FDA-approved test, and who have received a prior systemic therapy. The accelerated approval by the FDA was based on the results from the DESTINY-Lung02 Phase II trial. An interim efficacy analysis in a pre-specified patient cohort showed T-DXd (5.4mg/kg) demonstrated a confirmed ORR of 57.7% (n=52; 95% CI 43.2-71.3), as assessed by blinded independent central review, in patients with previously treated unresectable or metastatic non-squamous HER2-mutant NSCLC. Complete responses (CR) were seen in 1.9% of patients and partial responses (PR) in 55.8% of patients with a median DoR of 8.7 months (95% CI 7.1-NE).
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
The management of lung cancer is a major public health challenge. Molecular anomaly testing is recommended from the early stages for optimal and personalized care of all lung adenocarcinomas and non-smoker lung cancers. The search for these anomalies relies on increasingly advanced and sensitive analysis techniques, particularly Next-Generation Sequencing (NGS), which can simultaneously detect various molecular abnormalities in both DNA and RNA, including point mutations, complex mutations, rearrangements, and amplifications. These techniques are predominantly performed on biopsy specimens embedded in paraffin. However, these biopsies may require invasive and sometimes iatrogenic procedures, and their feasibility, quantity, and quality of the samples can be limited. The turnaround time for analysis results from the time of biopsy is typically around 2 to 3 weeks. In recent years, alongside the improvement in the sensitivity of molecular analysis techniques, liquid biopsy has emerged as a valuable approach, particularly in the analysis of circulating tumor DNA (ctDNA). ctDNA is a non-invasive diagnostic biomarker that has been validated for detecting targetable molecular anomalies similar to those detected by "conventional" biopsies. ctDNA can be detected in plasma through a simple blood draw, as well as in cerebrospinal fluid, urine, saliva, or any other "liquid" sample from the patient. The concordance between mutations identified in the tumor and those detected in the blood exceeds 90% specificity in numerous studies. However, the sensitivity of ctDNA detection varies depending on the stage of the disease and the sensitivity of the detection technique used. The utility of bronchial ctDNA is currently underexplored. However, there is a rationale for investigating ctDNA as close as possible to the cancerous lesion at the bronchial level. Bronchial ctDNA could play a role in molecular diagnosis for distal lesions not visible through endoscopy and could also help reduce costs and turnaround time for molecular diagnosis in larger tumors. The objective of this study is to evaluate the utility of liquid biopsy (ctDNA and ctRNA) during bronchoscopy in the molecular diagnosis and management of bronchial carcinomas. This is a prospective multicenter French study that will include 50 patients.
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)
Solid cancers and their therapeutic management remain a major public health problem due to their increasing prevalence and associated mortality. Among solid cancers, lung cancer ranks 4th among incident cancers. The prognosis remains poor, 33,117 deaths were recorded in France in 2018. Two histological forms of bronchopulmonary cancer are distinguished: non-small cell lung cancers (NSCLC), which represent 85% of bronchopulmonary cancer, and small cell lung cancers. The most common forms of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. The emergence of new so-called targeted therapies has considerably modified the management and prognosis of oncology patients and in particular of patients with NSCLC. These new molecules were developed following the molecular characterization of tumors on the one hand and on the other hand the characterization of the role of immunity in anti-tumor defense, particularly the Programmed Death receptor pathway 1 (PD-1). Blocking this pathway restores the anti-tumor potential of these lymphocytes. Pembrolizumab is a humanized monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with the Programmed Death Ligand-1 (PDL1) and Programmed Death Ligand-2 (PDL2), expressed by tumor cells but also by cells in the microenvironment. tumor and by antigen-presenting cells. Pembrolizumab thus potentiates T cell responses, including anti-tumor responses, by blocking the binding of PD-1 with PDL1 and PDL2. Pembrolizumab currently has marketing authorization (MA) for the treatment of NSCLC. Despite therapeutic progress due, among other things, to the emergence of anti-PD-1 antibodies including pembrolizumab, the prognosis of NSCLC remains poor and the use of pembrolizumab is sometimes limited by the occurrence of adverse effects. The pharmacokinetics of pembrolizumab was studied pre-marketing in patients with melanoma, NSCLC or metastatic or unresectable carcinomas. However, there are no data relating to the pharmacokinetic (PK) / clinical response (pharmacodynamic / PD) relationship of pembrolizumab, in real life. No prospective pharmacological study has in fact been published to date, especially in patients treated as part of the management of NSCLC. The absence of such studies - in real life - constitutes a pitfall given the existence of a possible association between PK data and the clinical response and/or toxicity of pembrolizumab.