Clinical Research Directory

Engagement of Veterans With Lung Cancer

This research study will help our understanding of whether additional support for Veterans with lung cancer can improve their quality of life.

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

The goal of this clinical trial is to investigate the utility of biomarker tools Extracellular Vesicles (EVs), Patient-derived organoid (PDOs), and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line (SoC 1L) platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

This study will monitor the safety of novel immunotherapy combinations in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells \[TC\]/ Tumor proportion score \[TPS\] \>= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Analysis of Circulating Tumor Markers in Blood - ALCINA 5

The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer

The goal of this observational study is to learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are: * Does pneumonectomy bring more benefits for pateints than lobectomy? * Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment and the study will analyze the data.

Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer

The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.

Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer

This trial is a multicenter, open-label, non-interventional controlled study to identify and characterize epigenetic signatures of lung cancer. The goal of this study is to develop a simple blood test that can detect lung cancer with high sensitivity, and assist in the early diagnosis and management of lung cancer. In particular, the ability to assist existing methods in cancer diagnostics, predict response to treatment, and assess the success of treatment during and after treatment will be examined. In addition, the ability to assess minimal residual disease (MRD) will be evaluated, by taking blood after surgery to remove a tumor or after treatment, and testing whether there is any residual DNA from the tumor using the markers that are found. The collection of patients and data will be conducted over a period of about a year and a half, with the aim of reaching approximately 300 participants, including patients with lung cancer before and after treatment/surgery and control groups.

Exploration of Risk Factors for Postoperative Cerebral Infarction in Lung Cancer Patients: a Retrospective Single-centre Study

Lung cancer remains the world's leading cancer in terms of morbidity and mortality, with more than 20 million new cases and 9.7 million deaths annually. Despite improvements in surgical techniques and medical care, the number of elderly people undergoing surgery is gradually increasing, so there are an increasing number of complications following lung resection. Postoperative cerebral infarction is a relatively rare but devastating complication that places a heavy burden on patients and families. The incidence of postoperative cerebral infarction in patients after thoracic surgery has been reported to be 0.6-1.1%. There is a risk of postoperative cerebral infarction after lung cancer surgery, and the results of a few studies have shown that postoperative cerebral infarction is related to old age, male, hypertension, hyperlipidemia, and lobectomy factors, but the pathogenesis of the occurrence of cerebral infarction has not been clearly proved for the time being, and so these risk factors cannot be taken as the direct cause of cerebral infarction. Therefore, we need to further explore the factors leading to cerebral infarction after lung cancer surgery. If we can further prove that some of the risk factors are related to the causes of cerebral infarction after lung cancer surgery, we can make corresponding strategies in the perioperative period to improve the safety of surgery and reduce the incidence of cerebral infarction in the postoperative period.

Quality of Life as a Predictor of OS and PFS in Patients With Lung Cancer

By 2020, lung cancer continues leading the first cause of cancer mortality and the second most common type of cancer in the world. There are limitations to early detection and then more than 60% of patients are diagnosed in advanced stages where there are no longer curative options; that situation is associated with high mortality and poor survival. It is known that some clinical and biochemical parameters of the disease have been recognized as prognostic factors; however, it has been described that a reduction in the overall global quality of life score, mainly by physical function, increased pain, and dysphagia, are associated with mortality, and having high social well-being and global quality of life scores are associated with a lower risk of death. Objective: This study will measure association between Health-Related Quality of Life levels and mortality and progression free survival in advanced non-small cell lung cancer patients Patients and methods: This study will include patients with lung cancer histopathological confirmed including bronchus or trachea. Methodologically, the study has two components: One related to the exposure variable (HRQL), which involves a scale validation study, and other related to the measurement of the association between HRQoL and survival outcomes, which involves a prospective cohort analytical observational study. This last component will be carried out specifically with a sample of patients with non-small cell lung cancer (NSCLC). Results and impact: The project contribute to the implementation of tools adapted and validated in the Colombian context to assess the quality of life in patients with lung cancer. Additionally, knowing the relationship between quality of life and traditional oncological outcomes will provide tools to give patients with comprehensive treatment, and to have a prognosis of the disease that incorporates psychosocial aspects

SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type

Lung cancer can be divided into two major categories: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC accounting for about 85% and SCLC about 15%. The prognoses of different types of lung cancer vary significantly. Early identification of different pathological types of lung cancer is crucial to the patient's prognosis. Raman Spectrum (RS), as a non-invasive and highly specific molecular detection technique, can obtain information at the molecular level, thereby sensitively detecting changes in biomolecules related to tumor metabolism such as proteins, nucleic acids, lipids, and sugars. Surface-enhanced Raman spectroscopy (SERS), developed based on this technology, is one of the feasible methods for high-sensitivity biomolecular analysis. In preliminary study, the investigators collected serum Raman spectral data from a cohort of 233 patients with malignant lung tumors and built a Raman intelligent diagnostic system for SCLC and NSCLC based on a machine learning model, achieving an accuracy rate of 80%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical study aims to validate the use of this intelligent diagnostic system for the early diagnosis of SCLC.

Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques

The goal of this multicenter observational study is to evaluate the long-term survival and perioperative outcomes of sleeve lobectomy in robotic-assisted thoracic surgery (RATS) for patients with central lung cancer when compared with video-assisted thoracic surgery (VATS) approach, both of which have been already applied to these patients in minimally invasive surgical techniques as part of their regular medical care recently. The main question it aims to answer is: Are RATS sleeve lobectomy associated with similar or even better long-term survival and perioperative outcomes for patients with central lung cancer when compared with the VATS approach?

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

This is a phase II study. All patients are stage IV non-squamas non-small cell lung cancer(NSCLC) with malignant pleura effusion, Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC with malignant pleura effusion.

The Diagnostic Value of Bronchoscopic Needle-based Confocal Laser Endomicroscopy (nCLE) As a Real-time Detection Tool for Diagnosing Peripheral Lung Cancer: a Multi-centre Randomised Controlled Trial

The goal of this prospective, multi-centre, randomised controlled clinical study is to evaluate the diagnostic efficacy and safety of nCLE guided lung biopsy in patients with for peripheral lung nodules under the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS), and assess whether the biopsy techniques, namely transbronchial crybiopsy (TBCB) and transbronchial forceps biopsy (TBFB), would influence the diagnostic efficacy and safety of nCLE guided biopsy. Participants will divided into nCLE-NB-rEBUS-forcep biopsy group, nCLE-NB-rEBUS-TBCB group, NB-rEBUS-forcep biopsy group, and NB-rEBUS-TBCB group at a 1:1:1:1 ratio by using central, computerized random sequence, and then undertake nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, and NB-rEBUS-TBCB according to the group. Researchers will compare the diagnostic yield and incidence of adverse events of the four biopsy techniques.

Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions

To evaluate the ability of \[68Ga\]N188 to detect nectin-4 overexpression in patients with lung lesions.

A Single-Arm, Phase Ⅰb Study of Golidocitinib Combined With Anti-PD-1 for the Treatment of Previously Treated NSCLC

This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with anti-PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with anti-PD-1 in combination with or without platinum-containing chemotherapy regimens.

Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC

This real-word study is designed to prospectively explore whether local treatment (surgery, ablation, radiotherapy and others) can prolong the time to treatment discontinuation during 1L lorlatinib treatment in Chinese patients with unresectable ALK+ NSCLC. Participation in this study is not intended to change the routine treatment received as determined by their attending physicians. Patients will be treated according to the routine medical practice in terms of visit frequency and types of assessments performed.

Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

Prolonged Air Leak (PAL) is a common and serious problem after lung surgery. It can lead to worse patient outcomes, longer hospital stays, and higher costs. Reinforced staplers are designed to make the staple line stronger and reduce the risk of PAL. However, investigators don't know if they are better than standard staplers, especially in a specific type of lung surgery called fissureless lobectomy for lung cancer. This study aims to find out if reinforced staplers are more effective at reducing PAL and its complications compared to non-reinforced staplers. Reinforced staplers have been used in lung surgeries and have shown to reduce PAL. For example, staplers with special materials like polyglycolic acid (PGA) sheets have shown lower air leakage and fewer days with chest tubes. Other materials like expanded polytetrafluoroethylene (ePTFE) sleeves have also been used to manage air leaks in different types of lung surgeries. However, their effectiveness in fissureless lobectomy has not been studied yet.