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Showing 1-13 of 13 trials
NCT07001618
The goal of IMMUNOLIFE2 is to overcome primary resistance to immune checkpoint inhibitors (ICIs), such as pembrolizumab or nivolumab used alone or in combination with chemotherapy, observed in patients with advanced non-small cell lung cancer (NSCLC) following antibiotic exposure, which induces intestinal dysbiosis. The reintroduction of immunotherapy with Cemiplimab, combined with oral pooled fecal microbiotherapy (MaaT033), aims to restore gut microbiota and potentially reverse resistance to ICIs. The main objective is to determine whether the combination of MaaT033 and Cemiplimab provides a superior disease control rate compared to the current best investigator's choice as comparator. Patients will be randomized to receive either: * Experimental arm: MaaT033 administered orally for one week prior to each cycle of Cemiplimab, which will be given in hospital care every 3 weeks for 6 months, followed by Cemiplimab alone thereafter; * Control arm: Best investigator's choice
NCT07491211
The goal of this retrospective real-world study is to evaluate the effectiveness and safety of first-line osimertinib combined with early intracranial stereotactic radiotherapy (SRT) in patients with EGFR-mutant non-small cell lung cancer (NSCLC) with symptomatic brain metastases. Eligible patients include adults with stage IV EGFR-mutant NSCLC who received first-line osimertinib monotherapy and early intracranial SRT. Data will be extracted from hospital medical records across multiple centers. The primary endpoint is real-world progression-free survival (rwPFS). Secondary endpoints include overall survival (OS), rwPFS2, time to next treatment or death (TTNT), and time to treatment discontinuation or death (TTD). Exploratory endpoints include CNS progression patterns, CNS progression-free survival (CNS PFS), CNS objective response rate (CNS ORR), and incidence of symptomatic CNS radiation necrosis.
NCT07469488
This study aims to explore the clinical outcomes of Comprehensive Enhanced Preventive Management (CEPM) combined with an amivantamab-containing treatment regimen in Chinese patients with EGFR-mutated advanced NSCLC.
NCT07356544
The HEROS study is an Italian observational multicenter prospective study aimed to investigate the current diagnostic and therapeutical approach towards HER2 mutated NSCLC in clinical practice. The enrolment will start in September 2024 until September 2025. A 12-months follow-up window will be performed.
NCT06956001
This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation. Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.
NCT07400575
Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer. This study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.
NCT06706076
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations. Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643. Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.
NCT07371663
This is a Phase Ib/II clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart /olaparib /topotecanfor patients with advanced solid tumors. The Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart /olaparib/topotecanin selected advanced solid tumor indications. The study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.
NCT07330596
Lung cancer is the leading cause of cancer-related deaths worldwide. According to the 2023 global cancer statistics, there are approximately 2.47 million new cases and 1.76 million deaths of lung cancer annually, accounting for 18.4% of all cancer deaths. Among them, driver gene negative NSCLC accounts for about 30% -40% of all NSCLC. In China, the incidence rate and mortality of lung cancer rank first. In 2022, there will be about 870000 new cases and 760000 deaths. In Chinese NSCLC patients, the EGFR mutation rate is about 50%, ALK fusion is about 5%, other mutations (ROS1, RET, etc.) are about 5% -10%, and the negative proportion of driver genes is about 30% -40%. Traditional treatment for late stage non-small cell lung cancer with negative driver genes has limited clinical efficacy. In recent years, the emergence of immune checkpoint inhibitors (ICIs) has greatly changed the treatment pattern of advanced non-small cell lung cancer patients, significantly prolonging the overall survival of advanced cancer patients. For the follow-up treatment of patients with previous immunotherapy, the current standard treatment regimen is still mainly chemotherapy. However, these plans have mediocre efficacy and significant side effects, making it difficult to meet the current clinical treatment needs. At present, there is no unified treatment plan for first-line immunotherapy or immunotherapy combined with chemotherapy in patients with driver gene negative advanced NSCLC. Second line chemotherapy such as docetaxel is currently recommended as the standard treatment plan in NCCN guidelines and CSCO guidelines. Research suggests that for patients with first-line immune resistance or immune combined chemotherapy resistance, second-line immune re challenge can still bring certain survival benefits to patients, but the benefits are limited and new treatment options need to be explored. Iparomlimab injection (drug number QL-1706) is a novel combination antibody independently developed by Qilu Company. It consists of Iparomlimab, an IgG4 antibody targeting PD-1, and Tuvonralimab, an IgG1 antibody targeting CTLA-4, in a fixed ratio. It has a synergistic mechanism of simultaneously blocking PD-1 and CTLA-4. In summary, ICIs are still an important treatment strategy for advanced non-small cell lung cancer. However, the emergence of drug resistance after immunotherapy seriously affects the survival time and prognosis of patients. Preliminary research has been conducted on the resistance mechanism of immunotherapy, but more research is needed to clarify the main mechanisms of action, in order to further prevent and overcome drug resistance. QL1706 has shown promising preliminary efficacy and good tolerability in PD-1 resistant NSCLC in preclinical and phase I clinical studies. Based on this, this study aims to conduct an exploratory study on QL1706 combined with chemotherapy compared to chemotherapy alone in the treatment of immune regulated non-small cell lung cancer with negative driver genes.
NCT07288632
Multicenter, prospective observational study (15 Oncologic Centers, in Italy). The purpose of the study is to assess the thromboembolic potential in patients with oncogene-addicted and wild-type NSCLC. The primary aim of this project is to evaluate the association between oncogene mutations and levels of plasma parameters of the activated coagulation cascade as the plasma levels of TF, thrombin generation, IL 6, vWF, ADAMTS-13 activity, PAI-1, and soluble P-selectin in NSCLC patients. A total of 500 NSCLC patients with a diagnosis (cytologically or histologically confirmed) of locally advanced or metastatic disease will be enrolled in the study, with a ratio of 1:1 for oncogene addicted or wild-type group. The oncogene-addicted group (Group A): patients with at least one oncogene mutation (i.e., patients expressing EGFR mutations, KRAS mutation, ALK or ROS1 rearrangements); the wild type group (Group B): patients without oncogene mutations, categorized in 2 subgroups according to expression of PD1/PD-L1 mutation or not. Patients will be followed up prospectively for 6 months or until death, VTE event, loss to follow-up, or voluntary consent withdrawal. This study will evaluate the effects of EGFR, KRAS mutations and ALK/ROS 1 and PD-1/PD-L1 rearrangements on the expression of TF and thrombin generation or the interaction between inflammation and endothelial or platelet and cancer cells, in patients with NSCLC. The study will also evaluate the potential correlation between VTE events and the expression of oncogene mutations in patients with NSCLC. The results of this study could generate the hypothesis of including the genetic profile as variable for a risk-stratification tools and decision-making algorithms in NSCLC patients.
NCT07150598
The goal of this observational study is to better understand how the immune system and certain tumor markers are linked to treatment response in patients with advanced non-small cell lung cancer (NSCLC) who receive immunochemotherapy. The investigators aim to answer the following questions: * Can the investigators successfully analyze immune markers and gene activity from small tumor samples (biopsies)? * Are these markers connected to how well patients respond to immunochemotherapy and how their disease progresses? What will participants do? * Provide tumor tissue samples (biopsies) at key points: before treatment, about 6 weeks after starting immunochemotherapy, and if the cancer grows or treatment changes. * Allow their tumor samples to be analyzed in the lab using advanced techniques to measure immune and genetic markers. * Share clinical information (such as treatment response and disease progression) so investigators can study how it relates to these markers. This study does not test a new drug or treatment.
NCT06969612
The goal of this clinical trial is to learn if golidocitinib combined with tislelizumab and chemotherapy works in advanced NSCLC with PD-L1≥1%. The main question it aims to answer is: Does the combination of golidocitinib with tislelizumab and chemotherapy can prolong the progression-free survival of patients with advanced NSCLC? Participants will： Take tislelizumab and chemotherapy for 2 cycles; and then take tislelizumab and golidocitinib for 2 cycles; after cycle 5, patients receive tislelizumab and chemotherapy until the patients were intolerant or the disease progressed.
NCT06896890
The combination of chemotherapy and immunotherapy shows promising results in terms of overall survival (OS) and progression-free survival (PFS) for the treatment of first-line stage IV non-small cell lung cancer (NSCLC) patients, leading to such combinations becoming a real backbone of the Standard of Care (SoC) for NSCLC patients. However, conventional chemotherapy's severe systemic toxicities represent a limiting factor in terms of administered dose and frequency. Administration of cisplatin by inhalation (pulmonary route) is a promising additional approach that may overcome the limitations of conventional chemotherapy. Use of a dry powder inhaler enables a high therapeutic response by delivering high local concentrations of a well-established active substance without the usual undesired reactions that limit the use of high doses when administered through the conventional systemic route. This study may provide insights into whether this add-on treatment might be a safe and potentially efficacious option for NSCLC patients.