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NSCLC clinical trials

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NCT ID: NCT04986293 Recruiting - Esophageal Cancer Clinical Trials

CPAP or BiPAP for Motion Mitigation During Radiotherapy

SISTER
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

When using highly conformal radiotherapy techniques, such as proton therapy, a controlled breathing pattern and a minimal breathing amplitude could greatly benefit the treatment of mobile tumors. This reduction in tumor motion may be achieved with the use of a ventilator that is able to regulate and modulate the breathing pattern. CPAP provides a constant level of positive airway pressure. Compared to spontaneous breathing, the use of CPAP increased lung volume and can result in a significant decrease in tumor movement and a significant decrease in both mean lung and mean heart radiation dose. These results were found in patients treated for limited stage disease, it is not clear if this approach is feasible for patients with more advanced stage of disease that undergo radiotherapy with curative intent. With Bilevel Positive Airway Pressure (BiPAP), tidal volume excursions are determined by the pressure difference between the set inspiratory positive airway pressure (IPAP) and the set expiratory positive airway pressure (EPAP). This mode of ventilation increases lung volume comparable to CPAP, but also to control tidal volumes and breathing frequency. However, BiPAP has never been studied in the setting of motion mitigation during radiotherapy and BiPAP might be more difficult to adjust to for patients compared to CPAP. Therefore, the current study is proposed to evaluate whether or not CPAP or BiPAP is of benefit in patients that undergo radiotherapy for larger intra-thoracic tumor volumes.

NCT ID: NCT04981119 Recruiting - Cancer Clinical Trials

Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing

BASECAMP-1
Start date: October 29, 2021
Phase:
Study type: Observational

Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.

NCT ID: NCT04969965 Completed - Healthy Volunteers Clinical Trials

To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations

Start date: June 21, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label and uncontrolled study to evaluate the comparative PK of EQ143 following oral single dose administration in adult healthy volunteers different racial and ethnic populations. A total of one (1) single dose cohort is planned at 110 mg of EQ143. EQ143 is an approved therapy in China at the 110 mg dose for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) T790Mmutation-positive, metastatic non-small cell lung cancer (NSCLC), who have progressed during or after EGFR tyrosine kinase inhibitor (TKI) therapy. A total of 45 (15 Caucasian, 8 Black/African American and 7 Hispanic/Latino, and 15 ethnic Chinese)

NCT ID: NCT04958967 Withdrawn - NSCLC Clinical Trials

Phase Ib Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation

Start date: October 1, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1 multi-center clinical study. To explore the efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation. The study plans to enroll 20subjects, including 20 treated patients aThe subjects will receive Furmonertinib Mesilate 240 mg/day or 160mg/day until disease progression, death or intolerability. The primary endpoint is Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC); the secondary study endpoints include ORR( Assessed by the Investigator),DCR,DOR,DpR,PFS,OS,CNS ORR( Assessed by the Independent Review Committee) In addition, the peripheral blood ctDNA will be collected and analyzed in this study

NCT ID: NCT04950907 Not yet recruiting - NSCLC Clinical Trials

Uniportal Tubeless VATS for the Evaluation of Biopsy for Second-generation Sequencing in Patients With Advanced NSCLC

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.

NCT ID: NCT04944069 Not yet recruiting - NSCLC Clinical Trials

Almonertinib With Bevacizumab for EGFR-Mutant NSCLC Patients With Leptomeningeal Metastasis

ATTRACT
Start date: July 2021
Phase: N/A
Study type: Interventional

A prospective, open-label, multi-center, single-arm study of Almonertinib combined With Bevacizumab for EGFR-mutant NSCLC patients with leptomeningeal metastasis.

NCT ID: NCT04939701 Completed - Ovarian Cancer Clinical Trials

Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants

Start date: January 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.

NCT ID: NCT04930133 Active, not recruiting - NSCLC Clinical Trials

Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy

Start date: February 24, 2020
Phase:
Study type: Observational

The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while > 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.

NCT ID: NCT04909684 Recruiting - NSCLC Clinical Trials

Dose Tapering and Early Discontinuation to InCreAse cosT-effectIveness Of Immunotherapy for NSCLC

DEDICATION-1
Start date: November 18, 2020
Phase: Phase 3
Study type: Interventional

Rationale: Immune checkpoint inhibitors have shown to improve the overall survival for patients with metastasized non-small cell lung carcinoma (NSCLC) but the optimal dosing and patient selection are still a matter of discussion. The pembrolizumab dose, for instance, may be reduced significantly without decreasing treatment efficacy. Furthermore, as approximately only half of all patients responds to treatment, there is an urgent need to develop (early) treatment response prediction markers to select those who benefit from treatment. Objective: Primary: to investigate the non-inferiority of pembrolizumab 75% versus pembrolizumab 100% in terms of overall survival. Secondary: to develop biomarkers that predict immunotherapy treatment response. Study design: An open label randomized non-inferiority study. Study population: 750 patients with NSCLC, eligible for treatment with pembrolizumab, in line with the current ESMO clinical practice guidelines. Intervention: Patients will be randomized to standard of care (100%) versus reduced dose (approx. 75%, depending on treatment schedule) pembrolizumab. Main study parameters/endpoints: One-year overall survival rate

NCT ID: NCT04892849 Recruiting - Esophageal Cancer Clinical Trials

Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy

ST-ICI02
Start date: April 30, 2021
Phase:
Study type: Observational

Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects