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NCT06312137
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
NCT07583771
This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).
NCT06814496
Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting. III) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT. A nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.
NCT05671510
The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.
NCT07222566
This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC. * Is not a candidate for complete surgical resection or curative chemoradiotherapy. * Do not have known actionable genomic alterations * Be treatment naïve for advanced or metastatic disease Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion: * Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor. * Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor. Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects. The study will include regular visits for: * Treatment and health checks: while participant continues receiving treatment. * Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.
NCT03340506
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
NCT05861947
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).
NCT03909334
The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.
NCT05616624
In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. Although safety and tolerability has been previously determined in the sarcoma population, dose de-escalations of the chemotherapies in that patient population were required. Therefore, a phase I portion will be incorporated to determine the RP2D of the triplet in this population.
NCT05180474
The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: * The side effects seen with GEN1047 * What the body does with GEN1047 once it is administered * What GEN1047 does to the body once it is administered * How well GEN1047 works against solid tumors The estimated trial duration for an individual participant is 8 months, consisting of a 28-day screening period, an estimated 3 month treatment period (the duration of treatment may vary for each participant), and an estimated 4 month post-treatment follow-up period (the duration of follow-up may vary for each participant). All participants will receive active drug; no one will be given placebo.
NCT05777603
Background: Non-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial changes may aid tumor growth. Researchers want to find out if treating the bacteria, too, can help cancer treatment work better. Objective: To test 2 inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer treatment, in people with NSCLC. Eligibility: People aged 18 years and older with NSCLC that has returned or progressed after treatment and cannot be treated with surgery. Design: Participants will be screened. They will have a physical exam with blood tests. They may blow into a machine to test how well their lungs work. They will have imaging scans. They may need to have a small piece of tissue cut from their tumor (biopsy). Participants will be treated in six 21-day cycles. They will visit the clinic to receive a drug for cancer treatment on the first day of each cycle. This drug will be administered through a tube attached to a needle inserted into a vein in the arm. The 2 antibiotic drugs will be in the form of a fine mist that can be inhaled. Participants use a device to take these drugs at home. They will inhale aztreonam up to 3 times a day and vancomycin 1 or 2 times a day. They will take these drugs during only 3 of the treatment cycles. Biopsies and other tests will be repeated halfway through and after the study treatment. Follow-up visits will continue for 1 year after study treatment.
NCT06834074
The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.
NCT06451497
This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.
NCT07507188
* In this study, we hypothesized that immune engagement by amivantamab will enhance antitumor efficacy by modulating the immune microenvironment in combination with lazertinib in patients with untreated EGFR-mutant NSCLC or with chemotherapy (carboplatin plus pemetrexed) after progression with 3rd generation (3G) EGFR TKI. * The primary objective of this study is to examine the patients' tumors for immunomodulatory effects of amivantamab-based regimens. * In a phase 2, two cohort clinical trial, treatment naïve patients with EGFR-mutant NSCLC will be treated with amivantamab SC plus oral lazertinib (Cohort 1, n=30) or patients with EGFR-mutant NSCLC progressed on or after 3G EGFR TKI treated with amivantamab SC plus chemotherapy (Cohort 2, n=30).
NCT07489391
Study objective and procedures The objective of CURIE-LC is to evaluate the feasibility (i.e., whether it is possible and safe) of carrying out a comprehensive exercise program during combined radiotherapy and chemotherapy in patients with lung cancer. The study will assess whether patients can adhere to the exercise program while receiving oncologic treatment and will explore its effects on physical fitness and quality of life. What does participation involve? If participants choose to take part, they will join a supervised exercise program conducted throughout the chemoradiotherapy treatment. The program includes three main components, tailored to the individuals' abilities: Inspiratory breathing exercise: training with a specialized device to strengthen the breathing muscles and improve lung capacity. Aerobic exercise: moderate-intensity aerobic activity (e.g., treadmill walking or stationary cycling) several days per week to improve endurance and cardiovascular health. Strength training: muscle-strengthening exercises (e.g., light weights or resistance bands) twice per week to maintain or increase arm and leg strength. A physiotherapist or other trained professional will guide the participant at all times to ensure exercises are performed safely and appropriately. Sessions will last approximately 20 to 60 minutes and will be coordinated with the radiotherapy/chemotherapy schedule so as not to interfere with the treatment. In addition to the exercise sessions, participants will undergo physical assessments and complete questionnaires at several time points. Before starting and at the end of the program, the investigagtors will measure functional capacity using the 6-minute walk test (6MWT) and assess respiratory muscle strength using maximal inspiratory and expiratory pressures (PImax and PEmax). Handgrip strength will also be measured. Participants will complete questionnaires about health status, fatigue, mood, and quality of life. These evaluations will help determine the impact of exercise during treatment. The exercise program will last for the duration of the treatment, approximately 7 to 9 weeks, with a short-term follow-up after treatment ends. Overall, participation involves attending the scheduled weekly exercise sessions during treatment, plus several evaluation visits (before, during, at the end of the program, and a few months later). Exact timing and frequency will be explained and planned according to the individual situation, aiming to minimize disruption to daily routine.
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....
NCT03068663
The subject is to study the lung microbiota and the one of upper airways (UAs) (much less studied than the intestinal microbiota) in 40 patients having lung cancer. 20 patients undergo only surgical treatment, while other half receives also chemotherapy. The idea is to explore changes in microbiota of the lung, upper UAs and intestine, and potentially find associations between them. These results will serve us as a base for the future study, focused on manipulation of the microbiota by prebiotics, probiotics or symbiotics and its effect on anti-cancer treatment tolerance and effectiveness.
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.
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.
NCT04977453
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.