Clinical Research Directory

The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer

Patients with rheumatoid arthritis (RA) have an increased risk of lung cancer, potentially influenced by targeted therapies such as JAK inhibitors and biologics. Extracellular vesicles (EVs) are key mediators of intercellular communication and may carry biomarkers involved in oncogenesis. This study aims to compare EV concentration and molecular content in RA patients treated with different targeted therapies. The objective is to identify treatment-related differences in EV profiles that may contribute to lung cancer development and improve risk stratification.

Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait

Lung cancer is a leading cause of cancer-related death in Kuwait, where most cases are diagnosed at an advanced stage and there is no national screening program. This prospective pilot feasibility study offers low-dose computed tomography (LDCT) screening to high-risk individuals aged 50-80 years (about 590 participants, so that about 500 complete a baseline scan), recruited by physicians at Ministry of Health polyclinics and hospital chest clinics and screened at the Chest Diseases Hospital. The primary objective is to assess the uptake of, and barriers to, LDCT lung cancer screening in Kuwait and to establish a framework for a national screening program. Participants undergo eligibility assessment (smoking history of at least 20 pack-years, totalled across all smoked tobacco products using pre-specified equivalency conversions for shisha/waterpipe, cigar, pipe, and roll-your-own tobacco), baseline assessment, and are offered three LDCT screening rounds (a baseline scan and two annual rounds) with Lung-RADS-based management and follow-up. Scans are read by radiologists without artificial intelligence (AI); at the end of the study, AI software is run once on the archived scans in a separate reader study. Findings will inform national lung cancer screening guidelines for Kuwait.

ERICA-02 Study : Impact of Physical Exercise on the Tumor Immune Microenvironment in Patients Treated With Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer

Recent advances combining chemotherapy and immunotherapy before surgery have significantly improved outcomes for patients with resectable non-small cell lung cancer (NSCLC). However, a substantial proportion of patients still do not respond optimally to these treatments. Researchers believe that physical activity may help strengthen the immune system and favorably modify the tumor microenvironment, potentially improving treatment effectiveness. ERICA-02 aims to investigate this hypothesis.The primary objective of ERICA-02 is to evaluate whether a structured exercise program performed during neoadjuvant chemo-immunotherapy can increase the presence of CD8+ cytotoxic T lymphocytes within the tumor. These immune cells play a key role in recognizing and destroying cancer cells and are considered an important marker of anti-tumor immune response.The study is designed for adults with locally advanced, resectable non-small cell lung cancer who are eligible for neoadjuvant chemo-immunotherapy followed by surgery. Participants must be medically fit to engage in physical activity, able to comply with study procedures, and provide informed consent before enrollment.ERICA-02 is a multicenter, randomized phase II pilot trial involving approximately 40 patients. Participants will be randomly assigned to one of two groups : intervention group and control group. Each participant will be involved in the study for approximately six months, including three months of exercise intervention for patients assigned to the exercise group.

Circulating Tumor Cells (CTC) in Lung Cancer

The primary objective of this study is to establish circulating tumor cell (CTC) derived xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples (personalize DNA repair therapy).

Longitudinal AI-Assisted Management of Indeterminate Pulmonary Nodules

Patients with indeterminate lung nodules often face a choice between continued CT surveillance and invasive investigation. This trial compares management with or without access to an AI report that matches nodules across real serial CT scans, measures change, and estimates validated malignancy or invasiveness risks. The principal question is whether offering the report reduces lung resections that yield benign pathology over 24 months. Diagnostic delay, cancer stage, treatment opportunity, complications, and longer-term cancer outcomes are also assessed.

Clinical Application of Artificial Intelligence Methods in Diagnostic Imaging of Pulmonary Nodules

This is a retrospective, multicenter observational study evaluating the clinical value of combining high-resolution (1024×1024 matrix) targeted CT scans with an artificial intelligence (AI) deep learning system to distinguish between benign and malignant pulmonary nodules. By analyzing existing medical records and CT images of adult patients (aged 18 and older) with pulmonary nodules (3-30 mm) who have confirmed diagnoses (via postoperative pathology）, this study aims to assess the diagnostic accuracy and efficiency of the AI system. The study plans to enroll approximately 10,000 cases from three hospitals in Shanghai. The primary goal is to evaluate the AI system's diagnostic performance (such as sensitivity, specificity, and Area Under the ROC Curve) and compare it with the performance of radiologists, ultimately exploring whether this combined approach can provide more accurate clinical diagnoses and reduce unnecessary procedures.

MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer

This study is a prospective single-arm clinical trial targeting patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who have received neoadjuvant immunotherapy. The primary objective is to evaluate whether a personalized follow-up and adjuvant treatment strategy-based on the combination of ctDNA-based minimal residual disease (MRD) testing and pathological response-can effectively improve the 2-year postoperative recurrence-free survival (RFS). The study will enroll 100 patients scheduled for radical surgery who have undergone neoadjuvant immunotherapy (in combination with platinum-based chemotherapy). Patients will receive individualized follow-up and adjuvant therapy based on dynamic changes in ctDNA at various preoperative and postoperative timepoints, as well as pathological response. Adjuvant therapy will be recommended if patients do not achieve pathological complete response (pCR) after surgery, or if ctDNA testing is positive after neoadjuvant therapy or post-surgery. Only patients who achieve pCR and have negative ctDNA at both specified timepoints will forgo adjuvant therapy; these patients will undergo blood sampling at each routine follow-up, with adjuvant therapy initiated upon ctDNA seroconversion to positive. The primary endpoint is 2-year RFS after surgery; secondary endpoints include overall survival (OS) and the diagnostic rate of recurrence/metastasis based on ctDNA-MRD testing. This project aims to explore the refinement of adaptive treatment strategies in the neoadjuvant immunotherapy lung cancer population, with the ultimate goal of improving overall therapeutic efficacy and establishing a standardized, integrated postoperative management system suitable for lung cancer patients.

Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer.

Lung cancer is one of the leading causes of cancer-related morbidity and mortality worldwide. Thoracic surgery remains the treatment of choice for patients with early-stage disease; however, postoperative recovery is frequently associated with reduced functional capacity, decreased physical activity levels, pulmonary complications, dyspnea, and impaired quality of life. Early physiotherapy interventions are recommended to minimize these adverse outcomes, although access to postoperative rehabilitation services remains limited in many healthcare settings, including the Andalusian Public Health System. Telerehabilitation has emerged as a promising strategy to improve access to rehabilitation services by delivering therapeutic exercise and clinical follow-up remotely. Previous studies have demonstrated that telerehabilitation is safe, effective, and cost-efficient across different clinical populations. However, evidence regarding its effectiveness in patients recovering from lung cancer surgery remains limited. This single-blind randomized controlled trial aims to compare the effects of an eight-week telerehabilitation program based on therapeutic exercise with usual postoperative care in patients with lung cancer undergoing thoracic surgery. Participants allocated to the intervention group will receive 24 therapeutic exercise sessions and 8 online clinical follow-up sessions delivered through the Rehbody platform over an 8-week period. Outcomes will include functional capacity, dyspnea, physical activity level, postoperative pulmonary complications, and health-related quality of life. The study is designed to address the following research question: In adults with lung cancer undergoing thoracic surgery (Population), does an eight-week therapeutic exercise-based telerehabilitation program (Intervention), compared with usual postoperative care (Comparison), improve postoperative recovery as measured by functional capacity, dyspnea, physical activity level, postoperative pulmonary complications, and quality of life (Outcomes)?

Diagnostic Performance of an AI-Based Multi-Omics Model for Early Lung Cancer

This is a prospective, multicenter observational cohort study for patients with lung nodules suspicious for early-stage lung cancer. The study aims to build AI-assisted diagnostic models by integrating clinical data, CT imaging and multi-omics biomarkers, and validate a rapid evaluation system for bronchoscopic biopsy specimens. No investigational drugs or devices will be applied; all participants receive routine clinical care. We will collect clinical records, CT images, blood and tissue samples, and conduct long-term follow-up of disease outcomes. A total of 1050 subjects will be enrolled from 8 participating hospitals in China.

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Background: Mesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN. Objective: To test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma. Eligibility: People aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment. Design: Participants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN. Participants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. Participant s T cells will be modified in a lab to produce TNhYP218 CAR T cells. Participants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment. TNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days. After discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy. Long-term follow-up will continue another 10 years....

TELESCOPE- TELEhealth Shared Decision-making COaching

Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict. Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers. Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).

Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer

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.

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery. The study is seeking participants who: * Are aged 18 years or older * Have either: * Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery. * Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples. * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously. * Be in good physical condition and have healthy organs based on medical tests. * Do not have known actionable changes in DNA The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis: * Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery. * Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor. * Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens. All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.

Benchmarking Large Language Models Against Tumour Boards for Oncology Treatment Recommendations

BEACON (Benchmarking AI for Clinical Oncology decisioNmaking) is a prospective, multicentre, comparative, blinded, non-interventional benchmark comparing the treatment recommendations of six frontier large language models (LLMs) with those of multidisciplinary tumour boards (RCP) in oncology treatment planning. One hundred standardised synthetic cases (20 per localisation, across breast, lung, urological, digestive and gynaecological cancers) are submitted as identical structured input to two independent tumour boards per localisation and to six frontier LLMs. Every recommendation, human or model, is decomposed into five predefined decision domains (intent, surgery, radiotherapy, systemic therapy with its line, work-up and biomarkers). For each domain, concordance between two recommendations is scored 2 when the same options are selected, 1 when at least one option is shared, and 0 when none is shared; the score is computed automatically from the recommendation forms, without human scoring. The primary endpoint is the mean domain score between each LLM and each tumour board, read against the same score computed between the two tumour boards of the same case, so that humans and models are measured by an identical rule and no respondent contributes to its own reference. A co-primary safety endpoint captures the proportion of recommendations carrying serious harm potential, because concordance alone can conceal dangerous errors. Where the two boards select different options, the case-domain is classified EQUIPOISE and, like every discordance, is adjudicated by an independent panel blinded to the source of the recommendation. Tumour boards record their recommendations during the meeting itself, on a dedicated platform (https://etude-beacon.fr) that reveals a case only once it is presented and time-stamps that reveal, so that no board can read a case in advance. BEACON is designed as reusable, openly licensed, pre-registered infrastructure: all synthetic cases, evaluation rubrics, scoring algorithms, verbatim prompts and raw model outputs are released for full reproducibility.

Radiomics for Distinguishing Benign and Malignant Lung Nodules

Differentiating between benign (non-cancerous) and malignant (cancerous) pulmonary nodules is a critical step in determining appropriate patient management and cancer treatment planning. Conventional evaluation using chest computed tomography (CT) relies on visual inspection of features such as size, shape, and borders; however, benign and malignant nodules frequently exhibit overlapping characteristics, which often necessitates invasive biopsy procedures. Radiomics is an emerging analytical technique that extracts high-dimensional quantitative data from standard medical images, including tissue texture, density patterns, and complex spatial features, that cannot be detected by visual inspection alone. The purpose of this observational study is to evaluate the utility of CT-derived radiomics combined with machine learning algorithms to non-invasively differentiate between benign and malignant pulmonary nodules. Researchers will extract quantitative imaging features from chest CT scans of patients presenting with pulmonary nodules measuring less than 5 cm to train and validate predictive machine learning models, with the goal of improving non-invasive diagnostic accuracy and reducing unnecessary biopsy procedures.

HTL0039732 in Participants With Advanced Solid Tumours

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.

A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Small/Middle Tier Cities and County Lung Cancer Quality Improvement Project (QIP) Study

To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.

Low-Frequency rTMS for Sleep After Thoracoscopic Lung Resection

This single-center randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) improves postoperative inpatient sleep in adults undergoing elective thoracoscopic lung resection for primary lung cancer. A total of 220 participants will be assigned 1:1 to active or matched sham stimulation. Five sessions will be delivered during seven perioperative calendar days, with no more than one session per day. The primary outcome is each participant's mean Richards-Campbell Sleep Questionnaire (RCSQ) total score across postoperative inpatient nights 1-3, calculated from at least two eligible nights. Secondary outcomes include length of postoperative hospitalization, pain, quality of life, actigraphy-derived sleep, anxiety, depression, electroencephalographic measures, and safety.

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)

Lung cancer screening (LCS) with low-dose computed tomography (LDCT) can reduce the risk of dying from lung cancer, but many people who are eligible for screening do not receive it. The purpose of the Empower LCS/Call+ study is to evaluate new strategies to improve lung cancer screening among adults who are eligible for screening based on current U.S. Preventive Services Task Force (USPSTF) guidelines. This pilot randomized controlled trial will enroll approximately 80 participants from UC Irvine Health and Emory Healthcare. Participants will be randomly assigned to receive either enhanced usual care or the Empower LCS/Call+ intervention. The intervention includes educational materials, reminders for patients and primary care providers, and information about financial and community resources when appropriate. Participants who do not complete lung cancer screening after the initial intervention may receive additional telephone-based navigation through the Call+ program to help identify and address barriers to screening and help with scheduling. Participants will complete a baseline survey and follow-up surveys at 4 and 8 months, and researchers will review electronic health record information to determine whether lung cancer screening was discussed, ordered, and completed. Some participants will also be invited to complete a one-time interview about their experiences with the study. The results of this study will help determine the feasibility, acceptability, and preliminary effectiveness of the Empower LCS/Call+ intervention and will inform future efforts to improve equitable access to lung cancer screening.

SPSIPB vs SAPB for Thoracoscopic Surgery

Video-assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours of the postoperative period. Analgesia management is very important for these patients in the postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after VATS. US-guided serratus anterior plane (SAP) block provides effective analgesia in the thorax's anterior, posterior, and lateral dermatomes. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery and VATS. There is no clinical randomized study in the literature evaluating the efficacy of SPSIPB and SAP block following VATS.

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system. The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.

SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC

This is a prospective, single-arm phase II clinical study. It intends to evaluate the efficacy and safety of stereotactic radiation therapy (SRT) combined with envafolimab and endostar as first-line treatment in stage IV non-small cell lung cancer (NSCLC) patients without actionable EGFR/ALK/ROS1 driver gene alterations and with PD-L1 TPS ≥ 1%. A total of 61 eligible participants will receive combination treatment of stereotactic radiotherapy, envafolimab and endostar. Tumor response will be evaluated every 6 weeks according to RECIST v1.1, and treatment-related adverse events will be monitored based on NCI-CTCAE v5.0. The treatment will continue until disease progression, patient withdrawal, loss of follow-up or death.