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NCT07668752
The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC). GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation. Preclinical studies showed GFH375 strongly blocks KRAS-driven signaling and cancer cell growth, and demonstrated anti-tumor activity in NSCLC animal models. Docetaxel is a chemotherapy drug for locally advanced or metastatic NSCLC. This is an open-label, randomized controlled trial. Both participant and study doctor will know which study medication each participant receives. After enrollment, participant will be randomly assigned to either the GFH375 group or docetaxel group by chance. Neither participant nor study doctor can pick your treatment group. You have a two-thirds chance to receive GFH375 and a one-third chance to receive docetaxel. * GFH375 group: Take GFH375 tablets by mouth once daily as scheduled; each treatment cycle lasts 21 days. * Docetaxel group: Receive docetaxel via intravenous infusion at 75 mg/m² once every 3 weeks. Study treatment will continue until cancer gets worse, participant can't tolerate the study treatment, or other conditions make participant unable to keep receiving study treatment. Some participants on docetaxel may be able to switch to GFH375 during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and participant 's wellbeing throughout the study. Participants will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After participant's cancer becomes worse, clinic staff will telephone participant every 3 mouths to check on their cancer.
NCT07528274
The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy. Participants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments: 1. Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W) 2. Docetaxel: 75 mg/m² administered intravenously every 3 weeks (Q3W) for 4-6 cycles 3. Microwave ablation, administered per protocol
NCT06253871
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
NCT07354061
The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC). It will also learn about the safety of this combination therapy. The main questions it aims to answer are: * Does Ensartinib combined with chemotherapy lead to a pathological complete response (pCR) in surgically removed tumor tissue after neoadjuvant treatment? * What medical problems do participants have when taking Ensartinib combined with chemotherapy? This is a single-arm study, meaning all participants will receive the investigational treatment. There is no placebo or active comparator group. The study will be conducted in two stages; the second stage will proceed only if no special, unexpected, or serious adverse events related to Ensartinib occur during the first stage involving 5 participants. Participants will: * Receive neoadjuvant treatment with Ensartinib (taken orally once daily) plus Pemetrexed and Carboplatin (administered intravenously every 3 weeks) for 9 weeks (3 cycles). * Undergo surgical resection within 4 weeks after completing neoadjuvant therapy. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (CT, MRI) according to a detailed schedule during the neoadjuvant, surgical, and long-term follow-up periods (up to 10 years). * Be monitored for adverse events and survival outcomes.
NCT04585750
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.
NCT05520099
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
NCT07274384
In metastatic NSCLC patients with PD-L1 expression ≥50%, a circulating immature (CD10-) LDNs level of ≥30.5% confers a high risk of hyperprogression (HPD) with first line single-agent immune-checkpoint inhibitors (SA-ICI). HPD is defined as a tumor growth rate (TGR) delta ≥50% between pre-treatment and post-treatment, and/or a TGR ratio ≥2. The combination of platinum-based chemotherapy (PCT) with ICI in this setting could prevent the occurrence of HPD and ultimately improve survival outcomes. This randomized, multicentric, open-label, phase 2 trial will include patients with stage IV NSCL, without targetable oncogene drivers, PD-L1 TPS≥50%, and measurable disease on two CT scans performed before randomization. Participants will be randomized 1:1 to SA-ICI or ICI+PCT. Radiological evaluation will be performed by CT-scan at 6-8 weeks and subsequently according to the local investigators' schedule. In the SA-ICI arm, ICI regimen will include cemiplimab. In the PCT+ICI arm, PCT regimens will include both carboplatin or cisplatin + pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology) in combination with cemiplimab. PCT will be administered for three cycles. In case of stable disease or partial response according to RECIST v.1.1, cemiplimab will be performed as monotherapy from the third cycle until disease progression or unacceptable toxicity. If progression according to RECIST v.1.1 or HPD after three cycles of PCT+ICI, patients will be treated with standard second line therapy as local standard of care.
NCT07106827
This is a single-arm, single-center study for multiple tumor indications to evaluate the safety of GV20-0251. The trial uses a 3 + 3 design and enrolls 3-6 patients in the 10 mg/kg and 20 mg/kg dose groups, respectively. The cancer types include solid tumors.
NCT06682793
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: * Enrollment in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose
NCT06977828
The goal of this clinical trial is to learn if tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy works to treat for resectable stage II-IIIB driver gene-negative NSCLC. It will also learn about the safety of tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy. The main questions it aims to answer are: 1. Does tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy can increase pCR rate as well as MPR rate、EFS、DFS、ORR、OS for resectable stage II-IIIB driver gene-negative NSCLC? 2. Is tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy safe? Participants with histologically or cytologically confirmed NSCLC, potentially resectable, driver gene negative (II- IIIB stage), and without prior systemic treatment, who have signed the informed consent, will be screened for inclusion. After receiving 4 cycles of tislelizumab combined with anlotinib and platinum-based doublet chemotherapy, the subjects will be evaluated by a multidisciplinary team (MDT) to determine whether to proceed with radical surgical resection. The surgery will be performed within 3 to 7 weeks after the last neoadjuvant treatment. Postoperatively, patients will be divided into two subgroups based on the pathological results: For patients with postoperative pathological pCR, tislelizumab monotherapy will be used for maintenance treatment; For patients with postoperative pathological non-pCR, tislelizumab combined with anlotinib will be used for maintenance treatment. Both groups will continue treatment until disease progression as defined by RECIST 1.1, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other situations specified in the protocol that require treatment cessation, whichever occurs first. The maximum treatment duration is 12 months. Survival and safety assessments will be continuously conducted thereafter.
NCT06967532
First discovered in 1997 the torque teno virus (TTV) can be found in the vast majority of the human population throughout their lifetime. The TTV levels correlate with infectious diseases and organ rejection and are therefore currently being investigated as a tool to optimize the management of patients after solid organ transplantation (SOT). While TTV levels are already tested to guide immunosuppressive therapy its significance for oncologic patients is unclear. In recent years immune checkpoint inhibitors (ICIs) are increasingly implemented in multimodal therapy approaches for patients with non-small-cell lung cancer (NSCLC). Since ICI and TTV levels depend on T-cell function, the TTV load may be a relevant biomarker for the treatment response as well as complication risk after ICI therapy. Current standard imaging using PERCIST and RECIST criteria is prone to misinterpretation of treatment response of ICI therapy due to pseudoprogression and nodal immune flaring. This study aims to prospectively analyze TTV levels in NSCLC patients before, during and after neoadjuvant chemo-immunotherapy and correlate inter- and intraindividual changes in TTV levels with response rates observed on PET/CT restaging and histopathological response rates as well as postoperative outcome.
NCT06939127
This is a Phase II single-arm study designed to evaluate the efficacy and safety of cryoablation combined with tislelizumab and platinum-based doublet chemotherapy as neoadjuvant therapy, followed by adjuvant tislelizumab therapy in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). The study consists of a screening phase, a treatment phase (including the neoadjuvant stage, surgery, and adjuvant stage), a safety follow-up period, and a survival follow-up period.
NCT06863506
This is a prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations. The study comprises two independent cohorts: Cohort 1: Patients with EGFR uncommon mutations (G719X, L861Q, or S768I). Cohort 2: Patients with EGFR exon 20 insertion mutation Primary endpoint: Objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints: Disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile (CTCAE v4.03).
NCT06684418
This nationwide, multicenter observational study aims to develop and validate a multimodal artificial intelligence (AI) model for detecting occult lymph node metastasis in early-stage non-small cell lung cancer (NSCLC) patients. Despite advances in lymph node staging, 12.9%-39.3% of occult nodal metastasis cases remain undetected preoperatively, affecting treatment decisions. This study will use deep learning to extract imaging features of occult metastasis and combine them with clinical data to build an AI model for risk prediction. This study will provide insights into the feasibility of AI-driven detection of occult metastasis, supporting clinical decision-making and potentially revealing underlying biological mechanisms of lymph node metastasis in NSCLC.
NCT06667167
Induction phase of carboplatin+etoposide+pembrolizumab followed by maintenance of Pembrolizumab+sacituzumab govitecan
NCT06727370
This study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.
NCT06614231
To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.
NCT01639001
This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer Patients. The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma Kinase) gene locus.
NCT03562819
This is a multicentre, prospective, study of EGFR )Epidermal Growth Factor Receptor) mutation status in advanced NSCLC (Non-small cell lung cancer)patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months.