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NSCLC clinical trials

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NCT ID: NCT06467383 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced

Key-Early
Start date: June 20, 2024
Phase:
Study type: Observational

This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II).

NCT ID: NCT06465238 Not yet recruiting - NSCLC Clinical Trials

Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.

NCT ID: NCT06462963 Not yet recruiting - Breast Cancer Clinical Trials

OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)

SPRINT
Start date: December 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate, NSCLC and colorectal cancer having all lesions that will be treated with radical radiotherapy amenable to single-fraction SBRT. The main question/hypothesis this clinical trial aims to answer is: - Single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy. Patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT.

NCT ID: NCT06457789 Not yet recruiting - NSCLC Clinical Trials

Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer

iRelate
Start date: July 2024
Phase: N/A
Study type: Interventional

The iRelate is a PET imaging trial to compare two upcoming and promising T cell PET tracers. Following chemo-immuno therapy, as part of standard care, NSCLC patients will be recruited to receive two PET scans, shortly before their surgery. Both PET scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor. This study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting PET tracers.

NCT ID: NCT06448910 Not yet recruiting - NSCLC Clinical Trials

The Efficacy and Safety of Cadonilimab (AK104) as Induction and Consolidation Therapy for Locally Advanced/Unresectable NSCLC Patients Receiving Concurrent Chemoradiotherapy

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this single arm, phase II clinical trial is to evaluate the efficacy and safety of cadonilimab (AK104) as induction and consolidation therapy in locally advanced/unresectable non-small cell lung cancer (NSCLC) patients treated with concurrent chemoradiotherapy. Participants will receive 2 cycles of induction therapy with cadonilimab combined with EP regimen, followed by standard concurrent chemoradiotherapy (thoracic radiotherapy +EP regimen chemotherapy), and finally consolidation therapy with cadonilimab (AK104) for 1 year.

NCT ID: NCT06422143 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

Start date: July 2, 2024
Phase: Phase 3
Study type: Interventional

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

NCT ID: NCT06414915 Not yet recruiting - NSCLC Clinical Trials

Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

NCT ID: NCT06400160 Not yet recruiting - Prostate Cancer Clinical Trials

Clinical Trial of TB511 in Advanced Solid Tumors

Start date: October 2024
Phase: Phase 1/Phase 2
Study type: Interventional

1. Study population [TB511 Monotherapy Cohort for Phase I and Phase IIa Clinical Trial] Participants with an advanced solid tumor who are either refractory or intolerant to standard of care (SoC). [Immune checkpoint inhibitors (ICIs) Combination Therapy Cohort for Phase IIa Clinical Trial] Participants with advanced solid tumor who have either not responded to or have relapsed after ICIs that are anti-PD-1 or PD-L1 inhibitors and who have no standard of care available. 2. Objectives of the Clinical Trial [Phase I Clinical Trial] 1) Primary Objective - To evaluate the safety and tolerability of TB511 monotherapy in Participants with advanced solid tumor to determine maximum tolerated dose (MTD) and recommended Phase IIa dose (RP2D). 2) Secondary Objectives - To evaluate the safety of TB511 monotherapy. - To evaluate the objective response rate (ORR) and anti-tumor effect (based on Response Evaluation Criteria in Solid Tumors Version 1.1, RECIST v1.1) of TB511 monotherapy. - To evaluate the pharmacokinetic characteristics of TB511 monotherapy. 3) Exploratory Objectives - To compare the changes in biomarker levels of TB511 monotherapy. - To evaluate immunogenicity by measuring anti-drug antibodies against TB511 [Phase IIa Clinical Trial] 1) Primary Objective - To evaluate the ORR of TB511 monotherapy and combination therapy with Pembrolizumab in Participants with advanced solid tumors (based on RECIST v1.1). 2) Secondary Objectives - To evaluate the disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) of TB511 monotherapy and combination therapy with Pembrolizumab. - To evaluate the safety and tolerability of TB511 monotherapy and combination therapy with Pembrolizumab. - To evaluate the pharmacokinetic characteristics of TB511 monotherapy and combination therapy with Pembrolizumab. 3) Exploratory Objectives - To compare the changes in biomarker levels of TB511 monotherapy. - To evaluate immunogenicity by measuring anti-drug antibodies against TB511

NCT ID: NCT06362980 Not yet recruiting - NSCLC Clinical Trials

A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations

EGFR
Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.

NCT ID: NCT06329648 Not yet recruiting - NSCLC Clinical Trials

Distributed Learning of Edic and CardIac Dose Effects in Lung Cancer

DECIDE
Start date: June 1, 2024
Phase:
Study type: Observational

Cardiac dose was not a major concern in lung radiotherapy patients until the results of the RTOG (Radiation Therapy Oncology Group) 0617 trial, which showed an association between cardiac dose and survival. Since then, many papers have studied the association between cardiac (substructure) dose and either survival or cardiac toxicity. Ideally, cardiac toxicity would be separated from survival. However, scoring cardiac toxicity prospectively was not standard practice, and retrospective scoring is challenging because of the overlap of cardiac toxicity symptoms and lung cancer (treatment) symptoms. Therefore in real world cohorts, cardiac toxicity is usually not scored properly and most larger studies pragmatically consider overall survival as primary endpoint, and the relation between cardiac dose and cardiac toxicity is not well established for lung cancer patients. Cardiac toxicity might not be the only factor in decreased survival; toxicity of the immune system might be a competing risk or a major contributing factor, where dose to the heart is a surrogate for dose to blood. Dose to the immune system is defined as EDIC (Effective Dose to circulating Immune Cells), comprising heart dose, lung dose and body dose combined. As EDIC dose and cardiac dose partly overlap, a large cohort with substantial variation will be required to disentangle the two effects. Such vast amounts of routine care data are immediately available in many radiotherapy centers all over the world. The problem we face is not the lack of routine care data, but making such data available for analysis. DECIDE adopts a federated learning approach, which implies that data does not have to be centralized within a single institution to be fit for use. We aim to include an unprecedentedly large-scale cohort of 20,000 patients. In this proposal, we need to add on scientific and technological innovations that exploit the existing federated learning framework to scale up to supporting >25 simultaneously connected partners. We will be training (generalized) linear epidemiological models as well as new computer vision-based models for outcome predictions. As cause-specific survival (cardiac toxicity or immune toxicity) is unavailable or unreliable in major studies, we will use the more pragmatic endpoint of survival. By elucidating the clinical contributions of whole heart dose, cardiac substructure dose and EDIC dose in combination with known clinical risk factors, the desired impact is to change clinical practice for lung cancer radiotherapy and improve survival.