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Carcinoma, Non-Small-Cell Lung clinical trials

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NCT ID: NCT06082492 Recruiting - Clinical trials for Stage III Non-small Cell Lung Cancer

The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients

NVALT31-PET
Start date: March 19, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F-Fluorodeoxyglucose Positron Emission Tomography/ Computerized Tomography (18F FDG PET/CT) versus follow-up with conventional CT surveillance. Participants will receive usual care until 3 years of follow-up (control group) with additional whole-body 18F FDG PET/CT scans during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up in the intervention group. Other tasks include: - filling in quality of life (QOL) questionnaires at every time point; - participating in an interview evaluating the addition of the 18F FDG PET/CT scans (optional); - collecting blood at the follow-up time points for our secondary endpoint (optional). Researchers will compare the usual care control group with the intervention group to see if the additional 18F FDG PET/CT scans are (cost)-effective.

NCT ID: NCT06081777 Recruiting - NSCLC Clinical Trials

Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

MRDinS3LC
Start date: November 25, 2022
Phase:
Study type: Observational [Patient Registry]

Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.

NCT ID: NCT06080776 Recruiting - Clinical trials for Non-small Cell Lung Cancer

SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations

Start date: May 11, 2023
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of SH-1028 tablets versus placebo in stage II-IIIB non-small cell lung cancer (NSCLC) patients with sensitizing epidermal growth factor receptor (EGFR) mutations, following complete tumor resection, with or without adjuvant chemotherapy.

NCT ID: NCT06079970 Recruiting - Lung Cancer Clinical Trials

Confocal Laser Endomicroscopy VERification

CLEVER
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy. The main question[s] it aims to answer are: To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure). Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.

NCT ID: NCT06077760 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

INTerpath-002
Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

NCT ID: NCT06074588 Recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Start date: November 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

NCT ID: NCT06069570 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC

Start date: November 7, 2023
Phase: Phase 1
Study type: Interventional

This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with metastatic non-small cell lung cancer to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.

NCT ID: NCT06068842 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer

METRIX
Start date: November 3, 2023
Phase:
Study type: Observational

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases of which 60% are non-squamous (NSQ). This study will evaluate the prevalence of mesenchymal epithelial transition (MET) overexpression (OE) in adult participants with advanced or metastatic NSQ NSCLC. Archived tissue biopsies will be tested for MET OE and data from approximately 500 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 15 months. There is no additional burden for participants in this trial.

NCT ID: NCT06068049 Recruiting - Clinical trials for Non-small Cell Lung Cancer

OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain

OSIREAL
Start date: July 28, 2023
Phase:
Study type: Observational

Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers. Osimertinib is indicated as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations in the EGFR, for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC, and for the adjuvant treatment of adult patients with NSCLC stages IB-IIIA after complete resection of the tumor that has activating mutations of the EGFR. The FLAURA trial showed that treatment with osimertinib significantly prolongs PFS and improves overall survival (OS) compared to standard EGFR tyrosine kinase inhibitors. The results of the ADAURA study showed a reduction in the risk of recurrence or death by 83% in stages II to IIIA, and in 80% in stages IB-IIIA. Additionally, osimertinib demonstrated a highly statistically significant improvement in DFS and HRQoL was maintained. To date, there are real-world data on osimertinib use in pretreated patients with stages IIIB-IV NSCLC EGFRm/T790M in Spain, obtained from the OSIREX study. However, there are no real-world data on osimertinib either in first-line treatment in locally advanced or metastatic EGFRm NSCLC nor as adjuvant treatment, in early stages of cancer, regarding effectiveness, adherence, treatment exposure and quality of life (QoL), among others, and in particular for the use of osimertinib in subpopulations less represented in pivotal trials as elderly or patients with uncommon EGFR mutations. Furthermore, the duration of treatmenti in real life is also a gap, as it appears to be longer than in clinical trials, which means that there are patients who are treated beyond progression, Therefore, this observational ambispective study based on real-world data aims to provide data on osimertinib use as adjuvant treatment in adult patients diagnosed with stages IB-IIIA EGFRm NSCLC and in first line treatment in patients with locally advanced or metastatic EGFRm NSCLC, in Spain, indications currently marketed in Spain. Specifically, the study will focus on patient characteristics, adherence, treatment exposure, administration, survival, QoL, effectiveness and safety providing insights into osimertinib use in daily practice for patients with EGFRm NSCLC, where there are current evidence gaps.

NCT ID: NCT06065813 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer

Start date: August 8, 2022
Phase: Phase 2
Study type: Interventional

Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer