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NSCLC clinical trials

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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: NCT06362369 Not yet recruiting - Colorectal Cancer Clinical Trials

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

Start date: April 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens. Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b

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.

NCT ID: NCT06315010 Not yet recruiting - NSCLC Clinical Trials

REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis

REPOSE
Start date: August 2024
Phase: Phase 2
Study type: Interventional

REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene.

NCT ID: NCT06248606 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases

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

This is a single arm phase 2 trial is to evaluate the efficacy of SRS plus adagrasib for the treatment of brain metastases for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). A total of 30 patients will be enrolled on this study.

NCT ID: NCT06221670 Not yet recruiting - NSCLC Clinical Trials

Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK)

Start date: March 20, 2024
Phase: Phase 2
Study type: Interventional

This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.

NCT ID: NCT06218069 Not yet recruiting - NSCLC Clinical Trials

Immuno-pet iMaging resPonses administeRed Immune checkpoiNt inhibiTor

IMPRINT
Start date: August 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with [89Zr]crefmirlimab berdoxam PET imaging as an imaging biomarker.

NCT ID: NCT06182761 Not yet recruiting - NSCLC Clinical Trials

A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer

WUKONG-9
Start date: January 2024
Phase: Phase 2
Study type: Interventional

The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.

NCT ID: NCT06062823 Not yet recruiting - NSCLC Clinical Trials

Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations

Start date: October 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to explore the efficacy of afatinib in NSCLC harbouring EGFR PACC mutation subtype. The main question it aims to answer is: Afatinib is active in patients with advanced NSCLC harbouring EGFR PACC mutation subtype. Participants will undergo screening, follow by treatment if eligible for study participation and then enter follow up phase after study medication has stopped. Patients will take afatinib 40mg daily continuously, until the development of progressive disease or meeting discontinuation criteria. A treatment cycle is defined as 28 days.

NCT ID: NCT06054191 Not yet recruiting - NSCLC Clinical Trials

Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

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

This is a Phase II, two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations.