The Therapeutic Effect of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Platinum Sensitive Recurrent Small Cell Lung Cancer
This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.
NCT06467786 — Small Cell Lung Cancer
Status: Recruiting
http://inclinicaltrials.com/small-cell-lung-cancer/NCT06467786/
LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non-acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. Psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. Dialectical Behavioral Therapy (DBT) Skills Training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. However, DBT Skills Training has rarely been applied in patients with chronic illness. The investigators adapted DBT Skills Training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create LiveWell, an 8-session Skills Training protocol delivered one-on-one via videoconference. Building on preliminary data and aligned with the ORBIT model for behavioral intervention development, the first phase of this study (K99, Aim 1, 1 year) aims to iteratively refine LiveWell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the Dynamic Sustainability Framework from implementation science, and 4) user testing (n=10). The K99 phase will produce a standardized protocol and procedures for the R00. The second, independent phase of the study (R00, Aim 2, 3 years) will be a Phase IIB randomized pilot trial to test study feasibility, acceptability and outcome patterns suggesting the efficacy of LiveWell compared to Enhanced Usual Care (EUC). Lung cancer metavivors (n=80, >20% non-White) receiving care at an NCI-designated center and endorsing distress >3/10 will be randomized 1:1. The investigators hypothesize that: 1) LiveWell and EUC protocols and procedures will show evidence of feasibility (accrual N=80/20 months, >=80% adherence to interventions and assessments, <=20% attrition) and acceptability (>=3/5 satisfaction study procedures, >=3 mean intervention satisfaction LiveWell)), and 2) LiveWell will improve quality of life (primary outcome) and reduce psychological distress (depression, anxiety, illness acceptance) and symptom burden (fatigue, dyspnea, pain) (secondary outcomes) from baseline to post-treatment compared to EUC. The investigators will explore emotion regulation as a mechanism of change. Findings from this study will inform an R01 submission to conduct a Phase III efficacy trial. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.
NCT06464562 — Cancer Metastatic to Lung
Status: Not yet recruiting
http://inclinicaltrials.com/cancer-metastatic-to-lung/NCT06464562/
Phase II Clinical Study of Almonertinib in Combination With Lastet in the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations
The goal of this clinical trial is to test in Locally Advanced or Metastatic Non-small Cell Lung Cancer patients with EGFR Mutations. The main question it aims to answer is: Evaluation of the Efficacy and Safety of Aumolertinib in Combination with Lastet for the Treatment of EGFR-Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer in First-line Therapy. Participants will be treated with a combination of Aumolertinib and Lastet.
NCT06463171 — Lung Cancer Non-small Cell Stage IV
Status: Not yet recruiting
http://inclinicaltrials.com/lung-cancer-non-small-cell-stage-iv/NCT06463171/
Randomized Phase II Clinical Study of Liposomal Irinotecan or Etoposide Combined With Carboplatin and Serplulimab as First-line Treatment for Extensive Stage Small Cell Lung Cancer
Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.
NCT06462105 — Small Cell Lung Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/small-cell-lung-cancer/NCT06462105/
A Phase II Trial of Adoptive Cell Therapy With Tumor-infiltrating Lymphocytes in Patients With Non-Small Cell Lung Cancer
Aim of the study is to investigate the efficacy and safety of Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in NSCLC patients in a phase II clinical trial.
NCT06455917 — Non-Small Cell Lung Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/non-small-cell-lung-cancer/NCT06455917/
Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
The purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.
NCT06453889 — Lung Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/lung-cancer/NCT06453889/
Gumarontinib Combined With Third-generation EGFR-TKI in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Amplification Following EGFR-TKI Treatment Failure.
This study evaluated the efficacy and safety of gumarontinib combined with third-generation EGFR-TKI in the treatment of locally advanced or metastatic NSCLC with MET amplification after first-line EGFR-TKI failure, without limiting the type of third-generation EGFR-TKI. The study was divided into 2 cohorts: Cohort 1 included patients with MET amplification after third-generation EGFR-TKI first-line therapy resistance, and cohort 2 included patients with MET amplification after first-generation EGFR-TKI first-line therapy resistance.
NCT06452433 — Non-small Cell Lung Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/non-small-cell-lung-cancer/NCT06452433/
A Phase 2 Single-Arm Study of Neoadjuvant CChemo-Immunotherapy and Surgical Resection in Locally Advance Non-Small Cell Lung Cancer (NSCLC) With N3 Lymph Node Involvement
The goal of this clinical trial] is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage III non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.
NCT06449313 — Non-small Cell Lung Cancer Stage III
Status: Not yet recruiting
http://inclinicaltrials.com/non-small-cell-lung-cancer-stage-iii/NCT06449313/
Patient and Physician Preferences for Potentially Resectable, Non-metastatic Non-small Cell Lung Cancer Treatments
The purpose of this study is to investigate the perspectives and preferences of patients and healthcare professionals (medical oncologists, pneumologists, thoracic surgeons) regarding treatment options in the resectable non-small cell lung cancer (NSCLC) setting
NCT06448793 — Non-small Cell Lung Cancer (NSCLC)
Status: Not yet recruiting
http://inclinicaltrials.com/non-small-cell-lung-cancer-nsclc/NCT06448793/
Observation of Frailty in Lung Cancer Patients and Its Influencing Factors
Using the Integrated Conceptual Model of Frailty (ICMF) and Frailty Framework among Vulnerable Population (FFVP) as theoretical basis, the frailty status of lung cancer patients is described, and the physiological, psychological, and social frailty of lung cancer patients are comprehensively evaluated and analyzed. The influencing factors related to frailty are explored, in order to provide a basis for effective intervention research on lung cancer patients in the future.
NCT06448455 — Lung Cancer
Status: Recruiting
http://inclinicaltrials.com/lung-cancer/NCT06448455/