Clinical Research Directory

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.

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.

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.

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.

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.

MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients

This is a single-center, prospective, single-arm interventional study with historical control, designed to evaluate the clinical value of a multidisciplinary team (MDT)-based decision-making umbrella decision model in elderly patients with lung cancer. A total of 2,000 patients aged 60-90 years with newly diagnosed non-small cell or small cell lung cancer will be enrolled. Each patient will undergo comprehensive geriatric assessment and receive an individualized treatment plan formulated by an MDT comprising thoracic surgeons, geriatricians, oncologists, pulmonologists, rehabilitation therapists, and radiologists. Treatment options include surgery, ablation, stereotactic body radiotherapy (SBRT), neoadjuvant immunochemotherapy, targeted therapy, and best supportive care. The primary outcome is 3-year progression-free survival (PFS). Secondary outcomes include overall survival, objective response rate, quality of life (EORTC QLQ-LC43), incidence of adverse events (CTCAE v5.0), and healthcare economics. Historical controls (2014-2024) will be extracted from hospital records and matched using propensity score matching. The study aims to establish a standardized MDT pathway to improve treatment outcomes and reduce risks in the geriatric lung cancer population.

LUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in Canada

LUNG-ROLL is a retrospective cohort study that will describe the contemporary treatment patterns, prevalence and incidence, patient demographic and clinical characteristics, clinical outcomes, and healthcare resource use/costs for patients with lung cancer in Canada (specifically, Alberta and Ontario) using administrative data.

Family-centred Pulmonary Rehabilitation to Empower Carers

Chronic respiratory diseases are leading causes of death and disability worldwide, imposing an enormous burden on individuals, families, and societies. Dependence on others begins early in the disease course. Over 70% of people with a chronic respiratory disease rely on informal care for daily assistance. Informal carers face multiple demands that may affect their health and ability to provide care. However, support interventions remain largely absent. Informal carers have identified pulmonary rehabilitation as an opportunity to also support them. Pulmonary rehabilitation is a cornerstone non-pharmacological intervention comprising exercise training, education, psychosocial support, and behaviour change, and is known to improve symptoms, functional capacity, quality of life, and survival. Although including informal carers in pulmonary rehabilitation has shown promising benefits for family adjustment, pulmonary rehabilitation remains patient-centred, with no dedicated support for carers' specific needs. This study will therefore redesign pulmonary rehabilitation to act as a dual-support intervention for both people with chronic respiratory disease and their informal carers. The study aims to assess the effects of carer inclusive pulmonary rehabilitation on preparedness for caregiving. A total of 120 patient-informal carer dyads will be randomly assigned to either carer inclusive pulmonary rehabilitation or standard pulmonary rehabilitation. In both groups, patients will undergo pulmonary rehabilitation. In the carer inclusive pulmonary rehabilitation group, informal carers will also participate in the education and psychosocial support sessions, which will be specifically designed to also address their needs. In the standard pulmonary rehabilitation group, informal carers will not participate in the pulmonary rehabilitation programme.

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.

Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization

This study evaluates whether multiparametric chest magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI), performed without any contrast material, can distinguish malignant from benign lung lesions that were assigned Lung-RADS category 4 on a standard-of-care lung cancer screening low-dose CT. Participants who have a Lung-RADS 4 lesion on screening CT undergo one non-contrast research MRI of the chest at 3.0 Tesla. The MRI is added to standard care; no standard-of-care imaging, biopsy, or treatment is withheld or replaced, and the research MRI is not used for clinical decision making. Participants then continue routine clinical management, and the final nature of the lesion is established from pathology or microbiology when tissue is obtained, or otherwise from at least 24 months of clinical and imaging follow-up. The primary measure is the sensitivity and specificity of multiparametric MRI against that final diagnosis. Secondary measures include whether DWI alone performs as well as the full MRI protocol, how MRI compares with PET/CT in participants who had PET/CT as part of their care, and quantitative MRI thresholds (apparent diffusion coefficient, lesion-to-spinal-cord signal intensity ratio, native T1 and T2). This is an exploratory pilot and feasibility study. No formal power calculation was performed; the sample size is intended to support feasibility assessment, protocol optimization, and preliminary estimates of diagnostic performance.

Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC

To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS .

Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

Background: EP0057 (formerly CRLX101) consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or "nanoparticle drug conjugate" travels through the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule. Olaparib is a drug that may stop cancer cells from repairing the deoxyribonucleic acid (DNA) damage caused by chemotherapy. Researchers want to see how safe it is to give EP0057 and olaparib together and to see how well the combination treats a specific type of lung cancer called small cell lung cancer (SCLC). Objectives: To test the safety and maximum dose of EP0057 and olaparib together. To test how well they treat small cell lung cancer. Eligibility: Adults 18 and older with small cell lung cancer. Design: Participants will be screened with standard cancer care tests. Participants will get the 2 study drugs in 28-day cycles. EP0057 will be given every 2 weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most days. Participants will keep a pill diary. For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits. At study visits, participants may have: * Blood and hair samples taken * History and Physical exam * Questions about health and side effects * Pregnancy test * Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. * Computed tomography (CT) scan * Injection of EP0057 (twice per cycle) * Olaparib prescription Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will have a physical exam and blood tests. They may have a tumor biopsy. The study team will call the patient every 3 months for follow up after completing the study treatment.

A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors

To learn if KSQ-001EX is safe to give to participants with advanced forms of solid tumors.

Effects of Early Mobilization and Feeding After Lobectomy

This randomized controlled study evaluates the effects of early mobilization and early oral feeding, two components of the Enhanced Recovery After Surgery (ERAS) protocol, on postoperative outcomes in adult patients with lung cancer undergoing lobectomy at Ege University Hospital. Participants were randomly assigned to an intervention group or a control group. In addition to standard postoperative care, participants in the intervention group received an ERAS-based protocol consisting of sitting at the bedside approximately 5.5 hours after surgery, beginning mobilization at 6 hours, and walking at least 100 meters when clinically stable and approved by the surgical team. Oral water intake was started at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated. Participants in the control group received the clinic's standard postoperative care. The study compares postoperative pain, complications, chest tube duration, length of hospital stay, reoperation, readmission within 30 days, nutritional status, laboratory findings, and quality of life between the two groups. Participants are followed for up to three months after surgery.

Effect of Modified Arm Positioning on Shoulder Pain After Thoracoscopic Lobectomy

This study is a prospective randomized controlled trial aiming to reduce shoulder pain after lung surgery. Shoulder pain on the surgical side is common after video-assisted thoracoscopic lobectomy, affecting about 20%-58% of patients. It can limit coughing, moving, and sleeping, and may delay recovery. The pain may come from two sources: nerve stimulation during surgery and the prolonged arm position used during the operation. While nerve stimulation is hard to avoid, the arm position can be modified. Currently, most pain treatments rely on medications or nerve blocks given after surgery, which have side effects or risks. No one has tried to prevent the pain by changing the arm position during the operation. We plan to enroll 270 patients scheduled for thoracoscopic lung removal surgery at Chengdu Shangjin Nanfu Hospital. Patients will be randomly divided into two groups. One group will receive the standard side-lying position with arms extended on arm boards (traditional position). The other group will receive a modified position where both arms are bent at the elbows and wrapped with surgical drapes, without using arm boards (modified double-arm wrap position). Our main goal is to compare the rate of shoulder pain (on the operated side) within 24 hours after surgery between the two groups. We will also compare pain on the opposite shoulder, pain severity, time needed to set up the position, total surgery time, hospital stay, and any nerve or skin complications. This study has been approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University. All participants will provide written informed consent. The findings may help improve intraoperative positioning and enhance early recovery after lung surgery.