Clinical Research Directory

Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54

Low-dose CT Screening has been shown in two large trials in the United States (NLST) and Europe (NELSON) to increase overall survival in subjects 55 years of age and older with a strong smoking history. Unfortunately, in both North Carolina (NC) and South Carolina (SC), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. This study is aimed at decreasing the minimum age of screening in a high-risk 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.

Patient-Specific 3D Model-Assisted Preoperative Consultation for Thoracoscopic Lung Resection

This study is a single-center, cluster randomized controlled trial evaluating whether lung three-dimensional model-assisted preoperative consultation can improve shared decision-making in adult patients undergoing thoracoscopic anatomical lung resection. Six attending thoracic surgeons will be randomized to provide either three-dimensional model-assisted consultation or usual preoperative consultation. Patients in the intervention group will receive consultation supported by a generic lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from routine preoperative imaging. Patients in the control group will receive usual preoperative consultation according to current clinical practice. The primary outcome is patient-perceived shared decision-making measured immediately after consultation using the 9-item Shared Decision-Making Questionnaire. Secondary outcomes include anxiety, disease- and surgery-related knowledge, communication satisfaction, health-related quality of life, decision regret, consultation duration, and postoperative outcomes within 30 days.

Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening

The goal of this clinical trial is to learn if a behavioral "nudge" strategy, specifically a default option, can improve screening participation in populations at high risk for lung and stomach cancer. The main questions it aims to answer are: 1. Does presenting a screening appointment as a default option increase the likelihood that high-risk individuals will choose to be screened? 2. How do participants react, and what is their level of acceptance, when the nudge intervention is disclosed to them? 3. Does this transparency (disclosing the nudge) change their subsequent screening decisions? Researchers will compare a default option group to a standard control group to see if the nudge effectively increases screening adherence. Participants will: 1. Read a short educational text about lung or stomach cancer and its screening. 2. Complete an online questionnaire. 3. Make a decision regarding a simulated cancer screening appointment. 4. Read a disclosure explaining the behavioral nudge strategy used during the study. 5. Re-evaluate their screening decision and answer questions regarding their attitude toward the nudge.

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.

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients

To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.

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.

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....

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.

Construction and Feasibility Study of a Home-Based Intelligent Symptom Management Program for Lung Cancer Patients Receiving Combined Drug Therapy Based on Symptom Journey Profiling

The goal of this clinical trial is to develop and evaluate a home-based intelligent symptom management program based on symptom journey profiles for patients with lung cancer receiving combination drug therapy. The program will be delivered through the "Zhihu Feifang" WeChat mini-program and is designed to help patients monitor symptoms, receive personalized symptom management recommendations, and obtain timely support during treatment intervals at home. The study will assess the feasibility, acceptability, and preliminary effectiveness of this intelligent symptom management program. The main research questions are as follows: (1) Is the intelligent symptom management program feasible and acceptable for patients with lung cancer receiving combination drug therapy? (2) Compared with usual care, can the program reduce symptom burden and improve symptom self-management ability? (3) Can the program improve quality of life and help patients identify and manage symptoms more promptly during treatment intervals? Researchers will compare the intelligent symptom management program with usual care to evaluate its preliminary effectiveness. Participants will be randomly assigned to either the intervention group or the usual care group. Participants in the intervention group will: (1) Receive usual care plus the "Zhihu Feifang" WeChat mini-program intervention; (2) Use the mini-program during four consecutive treatment intervals, lasting approximately 4 months; (3) Complete regular symptom assessments through the mini-program; (4) Receive personalized symptom management education, coping strategies, and risk alerts based on their symptom severity and symptom changes; (5) Receive nurse monitoring and follow-up support when needed; (6) Complete questionnaires at baseline and at follow-up time points during the study; (7) Some participants may also take part in an interview after the intervention to share their experience and suggestions. Participants in the usual care group will receive routine follow-up care, including health education, telephone follow-up, and medical visit guidance.

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.

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.

Construction and Preliminary Evaluation of Dyadic Acceptance and Commitment Therapy for Couples With Fear of Lung Cancer Recurrence

The goal of this clinical trial is to develop a simple, scientific, effective, and culturally adapted dyadic Acceptance and Commitment Therapy (ACT) intervention program (the ADAPT program) targeting fear of cancer recurrence (FCR) among lung cancer patients and their spouse caregivers. The study will also evaluate the feasibility, acceptability, and preliminary effectiveness of the ADAPT program. The main research questions are as follows: * Is the ADAPT intervention program feasible and acceptable for lung cancer patients and their spouse caregivers? * Compared with usual care, can the ADAPT intervention program preliminarily reduce FCR levels in both patients and their spouse caregivers? Can the program improve coping styles, illness perceptions, family functioning, and intimate relationships among both patients and their spouse caregivers? Can the program enhance psychological flexibility and quality of life (QOL) in both patients and their spouse caregivers? Researchers will compare the ADAPT intervention program with usual care to evaluate its preliminary effectiveness in reducing FCR among lung cancer patients and their spouse caregivers. Participants will: * Receive the ADAPT intervention twice during each radiotherapy and/or chemotherapy cycle, for a total of three treatment cycles (approximately 3 months); * Complete questionnaires at baseline (before the intervention), immediately after the intervention, and one month post-intervention; * Report outcomes including FCR severity, FCR triggers, psychological flexibility, illness perception, dyadic coping, family functioning, intimacy, and quality of life (QOL).

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 .

Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: 1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

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.

Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN).

DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns

This is a prospective, observational, multicenter study, in which clinical and demographic data will be extracted from medical records. Convenience sample, with an estimated inclusion of 200 patients treated in seven participating centers. Eligible tumors for this project will be from patients with advanced (unresectable or metastatic) non-small cell lung carcinoma, who will start first-line oncological treatment in one of the participating centers between 2025 and 2026 (between January 2025 and January 2026). Patients must be over 18 years old and data must be available in electronic medical records. Medical records will be assessed to confirm patients' eligibility. Patients with localized disease amenable to local treatment, non-epithelial histology, small cell carcinoma and neuroendocrine tumor will not be eligible. A survey will be designed targeting thoracic and generalist medical oncologists, aiming to understand the factors guiding the choice of first-line treatment regimens and to compare these insights with real-world data. The survey will be directed to Brazil, with an estimated of 200 filled files.

3D Virtual Resection for Predicting Lung Function in VATS

This study aims to validate a novel preoperative assessment strategy using three-dimensional (3-D) computed tomography (CT) reconstruction and virtual resection simulation. The goal is to accurately predict postoperative pulmonary function in patients with non-small cell lung cancer (NSCLC) undergoing Video-Assisted Thoracoscopic Surgery (VATS) anatomical resection. Accurate prediction of postoperative lung function is crucial for patient safety. Traditional methods, such as segment counting, often lack precision because they assume all lung segments contribute equally to function, ignoring variations caused by tumors or emphysema. This study utilizes 3-D "virtual resection" to quantify the "Planned Resected Ventilated Lung Volume Fraction" (pRVLVF) before surgery. The study will recruit 60 participants divided into two groups: those undergoing lobectomy (n=30) and those undergoing segmentectomy (n=30). Participants will undergo standard thin-slice CT scans and pulmonary function tests (PFT) before surgery. Postoperatively, lung function and recovery will be tracked at 3, 6, and 12 months to develop a dynamic prediction model and evaluate the compensatory capacity of the residual lung.

Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC

Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous NSCLC

Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy

This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.

Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC

To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.

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).

Real World Registry for Use of the Ion Endoluminal System

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.