Clinical Research Directory

Development and Utilization of an Integrated Clinical Genomic Database

This observational study aims to develop an integrated genomic and clinical database to support the discovery and validation of biomarkers for cancer diagnosis, treatment selection, and prediction of treatment response. The study will include adults aged 19 years or older with diagnosed or suspected cancer, as well as consenting individuals undergoing routine health screenings at Samsung Medical Center. Researchers will collect residual tissue specimens obtained during routine diagnostic or therapeutic procedures and additional blood samples collected alongside routine clinical blood tests. Previously collected specimens from approved biobank resources may also be used. Genetic, molecular, and protein analyses will be performed on the collected specimens, and the results will be integrated with clinical information, including cancer diagnosis, treatment history, treatment response, and disease outcomes. Patient-derived organoids and immune cells may also be used to investigate drug responses in laboratory models. The study aims to identify biomarkers associated with cancer development, progression, and treatment response, and to support the development of diagnostic tools and personalized treatment strategies. No experimental treatments will be assigned as part of this study, and no additional tissue biopsies will be performed solely for research purposes.

Patient Needs and Preferences for NSCL Cancer Treatment Monitoring

The qualitative phase of the study will consist of focus group discussions (FGDs) with patients, caregivers, and clinicians. The aim is to explore the most relevant aspects of the experience of patients with lung cancer during treatment, considering three interconnected dimensions: the biophysical dimension (physical health and symptom burden), the psychological dimension (emotional, cognitive, and behavioural wellbeing), and the social dimension (social roles, relationships, and contextual resources). The study will also investigate patients' preferences and experiences regarding symptom monitoring by the clinical team during treatment. The first step will involve a literature review on patients' preferences and experiences with lung cancer symptom monitoring during treatment. Findings will be complemented by informal discussions with clinicians and patient representatives to ensure a comprehensive understanding of patients' priorities and to identify potentially overlooked aspects. The next step will involve FGDs with patients, caregivers, and clinicians recruited at IEO. The FGDs with patients and caregivers will be conducted in two phases. In the first phase, three FGDs will be conducted with five patients each, together with one FGD involving five caregivers. The objective will be to generate a comprehensive list of relevant attributes related to the reporting of Patient-Reported Outcomes (PROs), Patient-Reported Experience Measures (PREMs), Clinical Outcome Assessments (COAs), and the monitoring of quality of life through telemedicine systems and Digital Health Technologies (DHTs). In the second phase, two additional FGDs will be conducted: one with five patients and one with five caregivers. These discussions will focus on refining the initial list of attributes and identifying those considered most important by participants. At the end of this phase, the Nominal Group Technique (NGT) will be used to prioritise the attributes and establish the final list. The prioritised attributes will then be compared, with the support of clinicians, with the evidence identified in the literature. This step will ensure that all relevant aspects have been addressed and that potentially important elements not sufficiently represented during the FGDs are considered. Finally, a focus group with clinicians will be conducted to define the different levels of the selected attributes. The resulting attributes and levels will constitute the basis for the subsequent quantitative preference study, aimed at systematically assessing the relative importance of the different aspects of treatment experience, symptom monitoring, and quality of life from the perspective of patients and other relevant stakeholders.

Snakehead Fish Extract and Curcumin Co-Supplementation in Advanced Lung Cancer on Inflammation, Nutritional Status, and Quality of Life

Background: Patients with advanced lung cancer receiving systemic therapy often experience nutritional decline, systemic inflammation, and impaired quality of life. Channa striata extract and Curcumin may offer complementary nutritional and anti-inflammatory support, but clinical evidence for their combination is limited. The goal of this clinical trial is to learn if combined Channa striata (snakehead fish) extract and curcumin supplementation works to improve nutritional status, inflammation, and quality of life in adults with advanced lung cancer receiving systemic therapy. The main questions it aims to answer are: * Does Channa striata extract plus curcumin co-supplementation raise body weight in participants with advanced lung cancer? * Does this co-supplementation lower inflammatory markers in these participants? * Does this co-supplementation improve health-related quality of life in these participants? Researchers will compare participants taking Channa striata extract plus curcumin to participants taking a placebo (a look-alike capsule that contains no active ingredients) to see if the co-supplementation works. Participants will: * Take Channa striata extract plus curcumin capsules or placebo capsules 3 times daily for 9 weeks alongside their standard systemic therapy * Have their body weight (kg), body mass index, and mid-upper arm circumference checked (cm) * Give blood samples to test inflammatory markers * Answer questionnaire questions about their health-related quality of life (QLQ -C30)

Advance Care Planning Impact on the Consistency of Older Adults With Lung Cancer and Their Potential Surrogates Regarding Life-Sustaining Treatment Preferences

This randomized controlled trial examined whether an advance care planning (ACP) tabletop game ("Walking with Wishes") could improve the consistency of life-sustaining treatment preferences between older adults with lung cancer and their potential surrogates (family members or friends), compared to a standard ACP manual. Eligible dyads (patient-surrogate pairs) were randomized 1:1 to either the tabletop game intervention or the ACP manual control group. The primary outcome was the absolute gap score on the modified Life Support Preferences Questionnaire (m-LSPQ), measuring the difference between patient and surrogate preferences for five life-sustaining treatments (antibiotics, CPR, surgery, nasogastric tube feeding, and intravenous infusion) across nine health scenarios. Secondary outcomes included state anxiety (STAI-S) for both patients and surrogates. The m-LSPQ was assessed at baseline (T0), 2 weeks (T2), and 6 weeks (T3) post-intervention. The STAI-S was additionally assessed immediately post-intervention (T1) to capture acute emotional responses to the intervention.

Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer

In low-risk patients with stage I non-small cell lung cancer (NSCLC) surgical treatment with an anatomical resection is currently the standard of care. For medically inoperable patients with stage I NSCLC, radiation therapy is currently the standard treatment. The latest generation of radiation therapy modalities is Stereotactic Body Radiation Therapy (SBRT). In high-risk patients, minimal invasive surgery in terms of sublobar resection (wedge resection) with lymph node sampling is currently the recommended treatment approach for these patients, even though the evidence is limited. Additionally, SBRT is an alternative treatment option but the use in these patients is also based on weak evidence. So, it is highly warranted to compare these two treatment options in this group of patients in a randomized, controlled trial where selection bias can be eliminated. It is the specific aim of this study to provide such a trial allowing an evidence-based approach when deciding between surgery and SBRT as treatment for NSCLC in high-risk patients. The STRADOS study (STereotactic RADiotherapy Or Surgery) is an open randomized, controlled national multicenter study in which high-risk patients with stage I non-small-cell lung cancer (NSCLC) are randomized to receive either surgical treatment with minimal invasive wedge resection with lymph node sampling, or SBRT. The overall purpose of the study is to investigate the disease-free survival (DFS) after surgical treatment when compared to SBRT. The primary endpoint is DFS after 3 years. Secondary endpoint is quality of life after 1, 3, 6, 12 and 36 months. Tertiary endpoints are overall survival (OS) after 3 and 5 years; DFS after 5 years; re-admission adverse events and complications after 1, 3, 6, 12 and 36 months; health-care related costs within 12 and 36 months; PRO data - other than quality of life (QoL) (health condition, symptoms and functional level) after 1, 3, 6, 12 and 36 months and lung function test after 12 month.

BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies

The purpose of this study is to determine the efficacy of BRain-AVOidant proton craniospinal irradiation (BRAVO pCSI) in adult participants with leptomeningeal metastases from solid tumors.

Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)

This study is a multicenter, prospective, open-label clinical trial. It enrolls previously untreated patients with resectable stage IB-IIIB KRAS G12C mutation-positive NSCLC to evaluate the efficacy and safety of glesorasib sequentially combined with ivonescimab and chemotherapy as perioperative treatment for this patient population.

Real-Time Non-Invasive Localization for Multiple Lung Nodules

This study compares real-time non-invasive localization and manual CT-guided needle localization for multiple lung nodules under 20 mm. It primarily aims to evaluate the successful resection rate of pulmonary nodules.

The Clinical Application Value of CAIX-Targeted PET Hypoxia Imaging in Malignant Tumors

This project involves conducting integrated PET/MR or PET/CT imaging using a CAIX-targeted PET tracer (e.g., \[68Ga\]Ga-DOTA-CAIX peptide) in clinically diagnosed malignant tumor patients, aiming to achieve the following objectives: Patients with malignant tumors: To visually assess the hypoxic state of malignant tumors, with pathological immunohistochemical detection of CAIX expression levels as the gold standard, evaluate the detection efficacy and quantitative accuracy of CAIX PET imaging for tumor hypoxic regions; clarify the location, extent, and heterogeneous distribution characteristics of hypoxic subregions within tumors; conduct a head-to-head comparison with \[18F\]FDG PET imaging to assess the complementary value and differences of the two imaging techniques in tumor boundary delineation, metastatic lesion detection, and tumor burden evaluation; based on the hypoxic biological information provided by CAIX PET imaging, assist clinicians in designing hypoxia-conformal margin expansion for radiotherapy target volumes, aiding in the determination of personalized radiotherapy and combined treatment plans.

Navigation Bronchoscopy Guided Microwave Ablation Versus SBRT in Early NSCLC

Background: Stereotactic body radiotherapy (SBRT) is a standard definitive local therapy for medically inoperable early stage non-small cell lung cancer (NSCLC). Navigation bronchoscopy guided microwave ablation is an emerging alternative that may reduce treatment burden and avoid ionising radiation. However, comparative evidence against SBRT remains limited. Objective: To generate relevant comparative evidence to inform treatment selection for medically inoperable patients or patients who decline surgery with early-stage NSCLC. Methods: This is a Hong Kong led, pragmatic, multicentre, parallel group randomised controlled clinical trial with open label treatment delivery and blinded end point assessment. Eligible participants will be randomised one to one to navigation bronchoscopy guided microwave ablation or SBRT. Surveillance includes scheduled chest computed tomography at 1, 3, 6, 12, 18, and 24 months, with independent blinded imaging adjudication using a prespecified review charter. The primary end point is 24-month local tumour control, defined as absence of local progression of the treated lesion. The primary analysis will follow intention to treat and will test noninferiority using an absolute risk difference margin of 0.15. Secondary outcomes include time to local progression, progression free survival, overall survival, treatment related toxicity and serious adverse events, patient reported outcomes including quality of life trajectories, and healthcare utilisation such as hospital visits, unplanned admissions, and retreatment. The target sample size is 100 participants, providing adequate power for the prespecified noninferiority margin and supporting secondary outcome estimation. Impact: Findings will directly inform multidisciplinary decision making, local pathway design, and service planning in Hong Kong and collaborating centres.

Postoperative Pulmonary Function Assessment Based on Deep Learning Study

Improvements in low-dose CT screening have led to an increase in early-stage NSCLC diagnoses, with surgical resection-usually lobectomy or segmentectomy-remaining the primary curative option. In Hong Kong, however, patients frequently present with comorbidities such as chronic respiratory disease or cardiovascular issues, making the preservation of healthy lung tissue crucial for their long-term quality of life. Traditional surgical resection, such as lobectomy or segmentectomy, has certain limitations in terms of functional preservation. In contrast, robotic/navigational bronchoscopic ablation has emerged in recent years as a novel minimally invasive endoscopic treatment strategy. This approach has been implemented in select centers and demonstrates potential advantages, including faster postoperative recovery, reduced trauma, and improved preservation of pulmonary function. By leveraging advanced navigation systems, bronchoscopic ablation enables precise localization and ablation of pulmonary nodules, avoiding the extensive resection of healthy lung tissue required in traditional surgery. These benefits hold promise for enhancing patients' long-term quality of life and survival rates. Moreover, conventional pulmonary function tests like FEV₁ and diffusing capacity of the lung for carbon monoxide provide only a global assessment of respiratory capacity, which may not fully capture the regional changes in pulmonary function that occur following segmentectomy or lobectomy. Likewise, basic CT volumetry overlooks finer anatomical details such as segmental airway distribution, microvascular networks, and local alveolar compliance. Furthermore, there is currently a paucity of direct comparative studies between robotic/navigational bronchoscopic ablation and traditional surgical resection regarding postoperative pulmonary function and long-term outcomes. Supported by Research Grants Council, our work since 2019 has validated the feasibility and safety of this technique, leading to widespread recognition and numerous publications. However, most existing research is retrospective or derived from single-center data, with a primary focus on short-term safety and technical feasibility. To address these limitations, an integrative approach leveraging 3D-CT imaging and ML is proposed. Machine learning is a technology that uses algorithms to automatically learn from data and make predictions or decisions. Deep learning, a subfield of ML, utilizes multi-layer neural networks to effectively extract features and recognize patterns in complex, high-dimensional data. ML, and particularly DL, has demonstrated remarkable potential in various medical imaging applications, including lesion detection, tissue segmentation, and outcome prediction. By automatically learning complex patterns in high-dimensional data, ML and DL models can interpret subtle radiologic characteristics that may be missed by conventional analyses. In the context of 3D-CT imaging for NSCLC, DL architectures-such as convolutional neural networks-can extract detailed features from volumetric scans, enabling robust quantification of tumor size, shape, and location as well as refined assessment of lung parenchyma. When integrated with pulmonary function parameters and clinical data, these algorithms provide a powerful means to generate predictive models, identify at-risk patients earlier, and guide individualized treatment planning. Moreover, ML-driven approaches can adapt to evolving datasets over time, continuously refining and improving their performance. This scalability and adaptability are especially valuable in prospective studies, where large, multimodal datasets are collected to evaluate the long-term impact of different treatment strategies. Consequently, incorporating ML and DL in this research not only enhances the precision of outcome prediction but also contributes to a standardized framework for dynamic, personalized assessment of pulmonary function, guiding more informed clinical decision-making. The primary aim of this study is to determine whether segmentectomy truly offers better functional preservation than lobectomy, whether robotic/navigation-guided bronchoscopic ablation indeed achieves superior pulmonary function preservation compared to traditional surgical resection, and under which specific patient conditions each approach may yield the greatest benefit. By undertaking a prospective, well-designed investigation, the research will fill a critical gap in evidence regarding long-term functional outcomes, providing clearer criteria for selecting the most appropriate resection type. Moreover, the introduction of a standardized, integrative assessment tool has the potential to optimize surgical decision-making and postoperative care, ultimately improving survival and quality of life for early-stage NSCLC patients in Hong Kong and potentially informing best practices in other healthcare contexts.

Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer

The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.

Liquid Biopsy Assay of EBUS-TBNA Supernatant Fluid for Diagnosing Lung Cancer

Background and aim: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the gold standard of lung cancer staging, yet up to 15% of procedures produce inadequate samples for definite diagnosis or staging. In such cases, more invasive surgical procedures are usually considered. Fluid collected during EBUS-TBNA is centrifuged to produce a pellet for cell block histopathological examination , while the supernatant is usually discarded. It has been demonstrated that this supernatant can provide material for next generation sequencing (NGS) mutation analysis using liquid biopsy (LB) technics when the procedure yielded positive results (tumor cells were demonstrated in the aspirate). We wish to assess whether LB NGS of the supernatant may provide data regarding lymph nodes involvement in non-small cell lung cancer (NSCLC) in cases with a negative EBUS-TBNA evaluation (no tumor cell identified in the aspirate). Methods: A prospective feasibility study which will recruit participants with high suspicion for thoracic lymph nodes involvement in NSCLC who will be subjected to EBUS-TBNA. The final study group will comprise of 10 subjects with a negative EBUS-TBNA evaluation (no tumor cell detected) who will require surgical resection of the thoracic lymph nodes. EBUS-TBNA collected fluid will be centrifuged and separated. Cellular pellets will undergo cytological and histopathological evaluation, including tissue NGS, as usual. Cell-free DNA will be extracted from the supernatant and will undergo separate LB NGS targeted to genes frequently mutated in NSCLC. We will assess the concordance between the positivity of supernatant NGS and surgical lymph nodes staging, and the concordance between supernatant NGS and blood NGS. Expected results: We expect high concordance between surgical lymph nodes staging and supernatant NGS, that is, genetic mutations would be identified by the supernatant NGS in subjects with lymph nodes involvement by tumor, and not in those without it. Importance to Medicine: NSCLC is the leading cause of cancer mortality. Improving the effectiveness of EBUS-TBNA may reduce the need for additional invasive procedures, increase accuracy and reduce turnaround time of specimens.

Prospective Phase II Study of Concurrent Radiotherapy Combined With Full-Course Immunotherapy or Consolidation Immunotherapy for Locally Advanced NSCLC

This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in patients with unresectable, locally advanced non-small cell lung cancer.

Study of Three Endpoints to Assess the Benefit of Rehabilitation in Patients With Advanced Non-small Cell Lung Cancer Controlled After at Least 6 Months of Systemic Treatment

The objective of this study is to identify an outcome that is relevant for assessing the benefit of rehabilitation in patients with advanced or metastatic non-small cell lung cancer whose disease has been stable or responding for at least 6 months with systemic treatment. Many people living with lung cancer experience asthenia, which reduces daily activity, independence, and quality of life. Regular physical activity (PA) is recommended for the management of all chronic diseases, including cancer. PA can be done independently by the patient or supervised by adapted physical activity instructors (EAPA) at home or in a day hospital (HDJ) in medical and rehabilitation care departments (SMR), where it is covered by social security. Rehabilitation program and physical activity may help improve strength, function, and social participation, for patients with non-small cell lung cancer . In this study, patients will participate in a 3-month rehabilitation program. We will measure quality of life, hand grip strength, and the Five Times Sit to Stand Test, before and after the program. Other measures will include daily step counts, nutrition, overall health status, continuation of cancer treatment, program adherence, and participant satisfaction. About 63 participants will be recruited in several hospitals, including CHUGA, CHMS and CHANGE. This patients will be able to choose a program that suits them and is available as part of they care. We are expecting 50 patients to participate in one of the rehabilitation program. The main goal is to identify the most useful outcomes to assess in future studies that will compare different rehabilitation approaches for people with lung cancer.

CAIX-targeted PET/CT in Solid Tumors

Tumor hypoxic microenvironment plays an important role in the initiation and progression of solid tumors, as well as tumor invasion, metastasis, and treatment resistance. Carbonic anhydrase IX (CAIX), as a crucial downstream molecule regulated by hypoxia-inducible factor-1 (HIF-1), is highly expressed in various solid tumors and is closely associated with tumor invasiveness, treatment response, and prognosis; thus, it represents an ideal target for tumor diagnosis and therapy. This study aims to explore the diagnostic value of CAIX-targeted PET/CT imaging in various solid tumors, as well as the correlation between tumor uptake and tissue CAIX expression.

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.

Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.

A Study of PHN-012 in Patients With Advanced Solid Tumors

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Clinical Investigator-Initiated Trial (IIT) of PD-L1-Targeted Radionuclide Probes

\[18F\]F-PDL1-3 molecular probe was used to detect the expression of PD-L1 in primary and metastatic tumors of patients with solid tumors. The heterogeneity of PD-L1 expression in the same lesion and different lesions was further evaluated, and the changes of PD-L1 expression in the course of the disease were observed. This method is helpful for the screening of patients with solid tumors with high PD-L1 expression, efficacy monitoring, and early warning of drug resistance and/or recurrence or metastasis, and ultimately achieve individualized targeted therapy of tumors

Cardiorespiratory Fitness After Lobectomy Versus Sublobar Resection

This observational study will compare changes in cardiorespiratory fitness after lobectomy and sublobar resection. Sublobar resection includes segmentectomy and wedge resection. Patients who can undergo pulmonary resection and meet the eligibility criteria will be studied during routine clinical care; the research will not assign the surgical procedure or add a study-specific intervention. Cardiopulmonary exercise testing (CPET) and pulmonary function testing will be performed before surgery and at routine follow-up visits 6 and 12 months after surgery. Changes from the preoperative assessment will be compared within each surgical group and between the two groups. The study will also examine the relationship between CPET measurements and postoperative complications.

Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations

This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings.

Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory

Informed Consent Form Protocol Title: Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory Version Number: V1.0 Version Date: April 1, 2024 Dear Subject: We invite you to participate in the study titled "Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory," which has been reviewed and approved by the Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. This informed consent form will provide you with some information to help you decide whether to participate in this clinical study. Your participation in this study is entirely voluntary, and your decision will not affect your normal rights and treatment at this hospital. If you choose to participate in this study, our research team will make every effort to ensure your safety and rights throughout the research process. Please read carefully. If you have any questions, please ask the researcher responsible for this study. I. Research Background, Significance, and Objectives: 1.1 Background and Significance With the extension of average life expectancy, the number of elderly lung cancer patients has also increased, with patients over 65 years old accounting for more than 50%. Elderly patients often have other diseases, low organ function, decreased cardiopulmonary function after surgery, and poor tissue repair capacity and immune function, making them more susceptible to complications such as atelectasis, pulmonary infection, and respiratory failure. Studies have shown that moderate exercise can reduce the risk of lung cancer, improve cardiopulmonary function and fatigue, increase muscle endurance and quality of life, shorten hospital stay, and reduce the incidence, mortality, and complication rates of lung cancer. The American College of Sports Medicine (ACSM) and the American Cancer Society recommend a total exercise volume of 150 minutes of moderate-intensity exercise or 75 minutes of high-intensity exercise per week, or an equivalent combination. Studies have shown that nearly two-thirds of cancer patients do not meet the recommended exercise volume and face risks of cardiovascular disease, diabetes, and premature death after surgery. Several countries, including the United Kingdom and Australia, have conducted exercise-related studies in patients undergoing lung cancer surgery. However, there is limited research on postoperative exercise intervention for the special population of elderly lung cancer patients both domestically and internationally, and there is a lack of postoperative exercise guidance and postoperative exercise management guidelines. Therefore, it is urgent to develop an exercise management program for this population. 1.2 Research Objectives This study aims to provide strong theoretical support for clinical medical staff to standardly guide postoperative exercise in elderly lung cancer patients, and also provides a template for the best evidence clinical application for other studies. II. Research Process: This study is a single-center clinical study. The expected number of subjects participating at this center is 68. If you agree to participate in this study, you need to sign this informed consent form. Afterward, we will conduct inclusion and exclusion criteria assessment. If you meet the inclusion criteria and do not meet the exclusion criteria, you will be enrolled in this study and have a 1/2 chance of being assigned to the control group or the intervention group. The intervention period is from 1 day before surgery to 2 weeks after discharge. During hospitalization, a rehabilitation physician and a respiratory therapy physician will jointly conduct a risk assessment, supervise, and guide the intervention for you. The intervention includes aerobic exercise, resistance exercise, respiratory training, etc. The intervention frequency ranges from 1-2 times per day to 1-4 times per week. It will be repeatedly reinforced in combination with authoritative exercise guidance videos until you have mastered it. The main part of the exercise guidance video is the specific exercise program, including the exercise methods you can choose, the duration of each exercise session, the weekly exercise frequency, and the exercise intensity. Corresponding demonstration videos and pictures of movements will be provided according to the exercise method you choose, so that you can practice at home. At discharge, you need to join the postoperative rehabilitation group. We will send the intervention guidance videos to the group, and you can save the videos to your mobile phone for reference at any time. At discharge, the rehabilitation physician will provide you with a paper or electronic exercise program for 2 weeks after discharge according to your condition. You w

Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.