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Showing 1-20 of 991 trials
NCT07328490
Background: Small-cell lung cancer (SCLC) is the most deadly form of lung cancer. It kills at least 250,000 worldwide each year. Extra-pulmonary neuroendocrine cancer (EP-NEC) is a similar type of cancer that develops anywhere other than the lungs. EP-NEC is also very aggressive. Better treatments are needed for these cancers. Objective: To test 2 drugs (tarlatamab combined with sacituzumab govitecan \[SG\]) in people with SCLC or EP-NEC. Eligibility: People aged 18 years and older with SCLC or EP-NEC that either did not respond to or returned after treatment. Design: Participants will be screened with a physical exam, blood tests, heart function testing, and imaging scans. Both study drugs are given intravenously (through a needle in the arm). Participants will receive a small starter dose of tarlatamab (1 mg) 2 weeks before beginning regular treatment, followed by the full dose (10 mg) one week later. Treatment then follows a repeating 4-week cycle: tarlatamab (10 mg) on days 1 and 15, and sacituzumab govitecan (7.5 or 10 mg/kg) on days 1 and 8. Treatment continues for up to 2 years, unless the cancer worsens, the participant passes away, or side effects become too severe. Participants will have regular check-ups including physical exams, blood tests, and imaging scans to monitor safety and treatment response. Blood and tumor samples will be collected for research purposes. After stopping treatment, participants will return for a safety check at 30 days, then be contacted every 3 months to check on their health and survival. Those who stop treatment for reasons other than cancer progression will continue CT scans every 8 weeks until their disease progresses.
NCT06066138
Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects. Objective: To test different doses and timing of atezolizumab for people with cancer. Eligibility: People aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug. Design: Participants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor. Atezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care. The first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later. For the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change. Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months. Study treatment may last up to 2 years....
NCT00068003
Background: The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will collect white blood cells from normal volunteers and white blood cells and/or tumor cells, from patients who have been screened for and are eligible for a NCI Surgery Branch treatment protocol. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth. The cells and/or tumor from patients will be used to make the cell treatment product. Eligibility: Patients must be eligible for a NCI Surgery Branch Treatment Protocol Normal Volunteers must meet the criteria for blood donation Design Both patients and normal Volunteers will undergo apheresis. Patients will then undergo further testing as required by the treatment protocol. There is no required follow up for normal volunteers.
NCT07485114
1. Background and Rationale:: Galectin-3 (Gal-3) is a β-galactoside-binding protein involved in various biological processes, including cell proliferation, apoptosis, adhesion, and immune regulation. In cancer, Gal-3 promotes tumor progression by enhancing cell survival, metastasis, and angiogenesis. Additionally, Gal-3 can upregulate Programmed Death-Ligand 1 (PDL-1) expression on cancer cells, contributing to immune evasion. PDL-1, an immune checkpoint protein, binds to its receptor PD-1 on T cells, inhibiting their activity and allowing cancer cells to escape immune detection. The interaction between Gal-3 and PDL-1 creates an immunosuppressive tumor microenvironment, reducing the efficacy of PDL-1 inhibitor therapies. Gal-3 drives the inflammatory response and can worsen the inflammation based side effects of PD-1/PDL-1 inhibitos. Understanding this interplay is crucial for optimizing treatments and improving patient outcomes in cancer immunotherapy. The present study employs the FDA-approved, automated Architect system, initially used in cardiology, to ensure high accuracy and consistency in Gal-3 measurement. This method represents a significant advance over traditional manual ELISA kits, aiming to standardize and reproduce results across the patient cohort and to optimize the application of XGAL-3 apheresis based on robust data. The study results can help optimize the use of the XGAL-3 therapeutic apheresis as an adjuvant treatment to enhance the efficacy and reduce the side effects associated with PDL-1 inhibitors. Therefore, the aim of this study is to conduct an observational clinical trial assessing the correlation between Galectin-3 Level and immunotherapy Outcomes in renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma patients treated with PD-1/ PDL-1 Inhibitors 2. Study Objectives: * Primary objectives: To correlate Gal-3 levels with patient outcomes, including response to treatment, duration of response, survival, and side effects observed. * Secondary objectives: To monitor and analyze serum Gal-3 level \& fluctuations over the course of PD-1/PDL-1 inhibitors in oncological patients. 3. Study enrollment and withdrawal: Inclusion/Exclusion Criteria: Inclusion Criteria: 1. Must be able to read and understand the informed consent form (ICF) and follow protocol requirements 2. Patients aged\>=18 years 3. Patients with renal cell carcinoma, Transitional cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma 4. Patients treated with PD-1/PDL-1 inhibitors 5. Patients prior to first cycle of PD-1/PDL-1 inhibitors 6. Subjects willing to continue and take part in the study for the throughout the study duration. Exclusion Criteria : 1. Female subject who is pregnant, lactating, or who want to get pregnant during the study period. Male subjects who want their partner to get pregnant. 2. Female of child-bearing potential who can't agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study. 4\. Study Design and Methodology: Study population: Oncology patients with renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma, receiving PD-1/PDL-1 inhibitors Study duration: 3 years Number of patients: 300 patients Study type: This is a prospective, observational. study evaluating the correlation between serum Gal-3 level \& fluctuations and treatment outcome of immunotherapy based PD-1/PDL-1 inhibitors in patients with renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma General Study design: The study will enroll participants from the Tel Aviv Sourasky medical center who are diagnosed with renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma, and treated with PD-1/PDL-1 based immunotherapy Methodology 1. Data Collection: clinical and laboratory data will be collected before treatment, including blood count and chemistry included liver function In addition, disease characteristics , demographic data (age, sex), treatment-related information (concomitant medications, dosages), and documentation of adverse events will be recorded each evaluation. All data will be entered into the CRF in accordance with study procedures. 2. Gal-3 blood levels: collected of 3 ml before every immunotherapy administration per treatment 3. Gal-3 blood levels testing method * Gal-3 blood level withdrawn of 3 ml each visit before each treatment * Samples will be frozen at -80°C microbiology lab and analyzed in pre-determined group size or periodical testing. * Utilize the ARCHITECT platform for all testing, with reagents supplied by Eliaz Therapeutics Inc, ensuring consistency and reliability in test results. 4. Statistical analysis: Upon trial completion, the possible correlation between Gal-3 levels and immunotherapy outcomes will be analyzed.
NCT05692635
The purpose of this research is to see if monitoring the brain using magnetic resonance imaging (MRI) after radiation therapy will allow investigators to find cancer that has spread to the brain (brain metastases) before it causes symptoms.
NCT06305754
The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS).
NCT07190248
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
NCT04253964
This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.
NCT07100080
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
NCT04960059
This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.
NCT07195695
This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow. In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation). Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits. Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.
NCT02973789
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
NCT05098132
This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.
NCT07476287
This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working. To join the study, participants must meet the following conditions: * Are aged 18 years or older * Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted) * Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs) * Have healthy organs based on medical tests and are in good physical condition After joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
NCT07122882
Currently, tyrosine kinase inhibitor (TKI) remains the standard of care for oncogene-driven non-small cell lung cancer (NSCLC). However, almost all oncogene-driven NSCLCs would develop acquired resistance against TKI in clinical practice. Therefore, understanding the molecular mechanisms underlying the acquired resistance is a critical issue in lung cancer. Based on the literature, acquired resistance mechanism against EGFR TKI includes EGFR secondary mutation (T790M, C797X, L792X, G796X, L718Q, and exon 20 insertions), MET amplification, HER2 amplification, acquired gene fusions, and other complex alterations. From the perspective of mutagenesis, the acquired resistance against TKI may be associated with APOBEC mutational processes, kataegis, chromothripsis, extrachromosomal DNA (ecDNA), and the interaction among them. However, still 30% to 50% of oncogene-driven NSCLCs had no identified mechanism attributed to the acquired resistance. Previous studies mostly used targeted-gene sequencing, which may overlook some structural variation and the transcriptomic dynamics. This study aims to investigate the genomic alterations, mutational processes, and the transcriptomic landscape underlying the acquired resistance using integrated genomics.
NCT06780137
Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
NCT07473128
The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is: Does trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer? Participants will be randomised to receive either trilaciclib or placebo.
NCT07472647
This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
NCT06357533
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
NCT06284317
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.