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Carcinoma, Non-Small-Cell Lung clinical trials

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NCT ID: NCT06088771 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC

Start date: March 8, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or patients who have a smoking history and radiographic findings highly suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy. On Day 1, participants will receive neoadjuvant therapy consisting of 600 mg of dupilumab (2 SC injections of 300 mg) and 350 mg of IV cemiplimab. Participants will undergo standard of care surgery, which will be scheduled within 7 days of Day 15. Participants will be followed up 30 days following administration of dupilumab and cemiplimab for adverse event (AE) and dose limiting toxicity (DLT) monitoring. Participants will be offered adjuvant therapy as per standard of care, outside the context of this clinical treatment, and undergo subsequent standard of care monitoring for recurrence. The study team will monitor the status of the participant through chart review, or by telephone should the patient not continue to follow with a physician at Mount Sinai, for up to 5 years.

NCT ID: NCT06084806 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

Test-retest Evaluation of [18F]F-AraG PET

Start date: October 31, 2023
Phase: Phase 2
Study type: Interventional

This pilot study aims to evaluate the test-retest variability of [18F]F-AraG-PET imaging in patients with advanced NSCLC tumors. The main objectives of the study are to quantify the uptake of [18F]F-AraG in tumors and lymphoid tissue in two consecutive scans spaced not longer than 7 days apart from each other to estimate the magnitude of physiologic and measurement variability. To explore these objectives, eligible subjects will undergo two [18F]F-AraG PET/CT scans within 7 days of each other prior to receiving treatment. This study is a single-site, open-label, non-randomized, single-arm pilot trial. Patients and care providers will not be blinded to any part of the study.

NCT ID: NCT06083870 Recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

Start date: December 13, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.

NCT ID: NCT06083857 Recruiting - Clinical trials for Non-small Cell Lung Cancer

PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer

Start date: June 18, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

To learn if the combination of amivantamab and tepotinib can help to control NSCLC. The safety of this drug combination will also be studied.

NCT ID: NCT06083454 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Ascorbate With Durvalumab in Non-Small Cell Lung Cancer (NSCLC)

Start date: October 23, 2023
Phase: Phase 1
Study type: Interventional

This is a descriptive, proof of concept, open-label, randomized, 3-arm, window of opportunity trial to evaluate the immunomodulatory role of pharmacological ascorbate with Durvalumab

NCT ID: NCT06082635 Recruiting - Clinical trials for Non Small Cell Lung Cancer

TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)

Start date: December 14, 2023
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, open-label, Phase III clinical trial which compares the safety and efficacy of TGRX-326 with crizotinib in patients with ALK-positive advanced or metastatic NSCLC

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.