View clinical trials related to Non-Small Cell Lung Cancer.
Filter by:In this phase I first-in-humans-study a vaccine consisting of arginase-1 (ARG1) peptides and the adjuvant Montanide ISA-51 will be tested in ten patients with metastatic solid tumors. Patients will be treated with an ARG1 vaccine every third week for 45 weeks.
The purpose of this study is to assess pain management after elective thoracoscopic lobectomy. The study will compare two local anesthetics that are given intra-operatively during lobectomy to see which one helps in better pain control and to see which one helps decrease the need for opioid medications. Participants will receive either Marcaine (Bupivacaine-epinephrine 0.25%, 1:200,000) or Exparel (Bupivacaine liposomal (1.3%)) and the drug will be chosen in a random fashion. Participants will be followed during the hospital stay and for one year thereafter. An visual Scale will be administered to measure pain, and opioid drug use will be measured by calculating morphine equivalent dose on each day post surgery until discharge and thereafter on 30 day, 6 month and 12 month follow-up visits. Participants will be monitored for any drug related toxicity and other co-morbid conditions for a period on one year post surgery. Overall cost for the surgery and during in hospital stay post surgery will be collected and compared between the two treatment arms.
Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. The primary objective is to evaluate if total baseline tumor mutation burden (TMB) in cell-free circulating tumor deoxyribonucleic acid (ctDNA) is predictive of objective response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by the investigator by estimating the level of association.
A Phase 3, Open-Label, Multi-Center, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Participants With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer. 45 sites will be involved in China, 320 subjects will be enrolled.
This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.
Lung cancer patients have a poor prognosis and only around 20 % is alive after 5 years. However, for advanced non-small cell lung cancer immunotherapy has become a cornerstone of treatment. Two immunotherapeutic drugs for lung cancer have been approved in the last two years. Immunotherapy blocks the capability of cancer cells to inactivate the patient´s immune system, thus re-enabling eradication of cancer cells. In clinical trials, immunotherapy has shown superior survival and less toxicity compared to standard chemotherapy. Whether the patients are candidates for immunotherapy or not is currently based on an unprecise biomarker that poorly predicts the patients who may benefit from immunotherapy. Immunotherapy can cause severe adverse effects and is expensive. Consequently, novel biomarkers are urgently needed from a patient perspective as well as a socioeconomic perspective. The objective of the project is to investigate changes in genes and other signals in tissue and blood samples from immunotherapy treated lung cancer patients. The investigators expect to identify new biomarkers that can predict with high precision, which patients may benefit from immunotherapy. On-treatment, the investigators also aim to identify biomarkers that predict the treatment response and reveal the underlying mechanisms when cancer cells become resistant to the treatment.
The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).
Rationale: Pemetrexed is a multi-targeted folate antagonist, which is primarily indicated for the treatment of advanced non-small cell lung cancer (NSCLC) and mesothelioma. Dosing of cytotoxic agents like pemetrexed requires balancing the dual risk of sub-therapy and toxicity. Administration of pemetrexed to patients with a creatinine clearance <45 ml/min is currently not advised. Pemetrexed is dosed based on body surface area (BSA), while renal function and dose are the sole determinants for systemic exposure. This causes 3 major issues: 1. In patients with renal dysfunction, BSA-based dosing may lead to haematological toxicity 2. Patients have to discontinue treatment due to declining renal function, and are withheld effective treatment 3. Even in patients with adequate renal function (GFR >45 ml/min) treatment may be improved by individualized dosing based on renal function, resulting in less toxicity. Also, BSA-based dosing may lead to ineffective therapy in patients with above average renal function. The investigators aim to address these problems. Objective: The overall main objective is to develop a safe and effective individualized dosing regimen for pemetrexed. Study design:IMPROVE-I is a single arm phase II pharmacokinetic safety study using a Simon two stage design to assess the feasibility of renal function-based dosing of pemetrexed in renal impaired patients. Study population: IMPROVE-I includes 23 patients with NSCLC or mesothelioma with an estimated creatinine clearance <45ml/min that meet all other requirements for pemetrexed treatment. Intervention:Patients will be treated with pemetrexed, with dosing based on renal function. As a safety measure, the first dose will be calculated to 50% exposure. After administration, safety and pharmacokinetics are assessed. If tolerated well, dose escalation to reach 100% exposure is performed, including assessment of safety and pharmacokinetics. Main study endpoints: The fraction (percentage) of patients with attainment of therapeutic exposure. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators consider the extra burden from participating in the planned studies limited. The extra interventions compared to routine care, consist of sampling extra blood. The pharmacokinetic assessments require placement of one additional intravenous catheter. To ensure minimal impact of study participation on daily life, a limited sampling strategy will be used. Patients may benefit from participating in IMPROVE I and -II, as they will be treated with a potentially safe and effective drug that is dosed individually, which prevents toxic exposure
Rationale: Pemetrexed is a multi-targeted folate antagonist, which is primarily indicated for the treatment of advanced non-small cell lung cancer (NSCLC) and mesothelioma. Dosing of cytotoxic agents like pemetrexed requires balancing the dual risk of sub-therapy and toxicity. Administration of pemetrexed to patients with a creatinine clearance <45 ml/min is currently not advised. Pemetrexed is dosed based on body surface area (BSA), while renal function and dose are the sole determinants for systemic exposure. This causes 3 major issues: 1. In patients with renal dysfunction, BSA-based dosing may lead to haematological toxicity 2. Patients have to discontinue treatment due to declining renal function, and are withheld effective treatment 3. Even in patients with adequate renal function (GFR >45 ml/min) treatment may be improved by individualized dosing based on renal function, resulting in less toxicity. Also, BSA-based dosing may lead to ineffective therapy in patients with above average renal function. The investigators aim to address these problems. Objective: The overall main objective is to develop a safe and effective individualized dosing regimen for pemetrexed. Study design: IMPROVE-III is an explorative microdosing study to assess the extrapolability of microdose-pharmacokinetics to the pharmacokinetics of a therapeutic dose. Study population: IMPROVE-III includes 10 patients of IMPROVE-I and/or IMPROVE-II. Intervention: patients will be administered a microdose with subsequent pharmacokinetic assessment. Main study endpoints: The predictive performance of microdosing to predict full dose pharmacokinetics
The first-line treatment with single agent AZD3759 results in superior Progression Free Survival (PFS) compared to Standard of Care (SoC) Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKI), in patients with advanced EGFR mutation positive non-small cell lung cancer (NSCLC) with Central Nervous System (CNS) metastasis