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Carcinoma, Non-Small-Cell Lung clinical trials

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NCT ID: NCT05020275 Recruiting - Lung Cancer Clinical Trials

Resistance to the Tyrosine Kinase Inhibitor Osimertinib and Pharmacokinetics in Non-small Cell Lung Cancer

RESISTYR
Start date: December 29, 2021
Phase:
Study type: Observational

Osimertinib is a tyrosine kinase (TKI) inhibitor targeting EGF-R (epidermal growth factor receptor) and used in the management of patients with non-small cell lung cancer (NSCLC) with oncogenic drug addiction to EGF-R. The results of the FLAURA study justifies this 3rd generation TKI as the first line TKI of choice since an increase in overall survival of several months has been observed compared to TKIs of previous generations (erlotinib, gefitinib). However, the response to osimertinib is heterogeneous and some patients are poor responder. In addition, even when an initial response to ITK is observed, the natural history of the disease inevitably leads to the appearance of resistance mutations and loss of efficacy of osimertinib after a few months of treatment.In the hypothesis of a concentration-effect relationship, an underexposure (an insufficient plasma concentration) to osimertinib could lead to a suboptimal response by favoring the appearance of molecular resistance. By analogy with the mechanisms of resistance to anti-infectives, the systemic concentration of TKI may have to be maintained above a certain value throughout the treatment to reach an effective concentration in the tumor, in order to to prevent the selection of resistant clones. The value of this approach for optimizing treatment with TKI has been shown for this therapeutic class. This mechanistic hypothesis has been suggested several TKIs. In addition, the association between pharmacokinetics of TKIs and the development of resistance has been reported in several pilot studies for dasatinib, erlotinib. Furthermore, a link between TKI concentration and ctDNA concentration was demonstrated in a pilot study by Garlan et al. in 11 patients treated for melanoma with vemurafenib. The impact of the results of this study is important since the aims are to identify preemptive and predictive biomarkers of drug response and to increase mechanistic knowledge regarding risk factor of resistance to osimertinib. Finally, if the hypotheses evaluated in this translational research study are verified, therapeutic drug monitoring of TKI (and ctDNA analysis) would be immediately applicable in clinical practice since the technical tools are already available in the laboratories of most hospitals centers.

NCT ID: NCT05017025 Active, not recruiting - Clinical trials for Stage IV Lung Cancer AJCC v8

Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-small Cell Lung Cancer

Start date: February 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial studies the side effects and best dose of aurora A kinase inhibitor LY3295668 when given together with osimertinib in patients with EGFR-mutant non-squamous non-small cell lung cancer that has spread to other places in the body (advanced or metastatic). Aurora A kinase inhibitor LY3295668 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving aurora A kinase inhibitor LY3295668 in combination with osimertinib may help control EGFR-mutant non-squamous non-small cell lung cancer.

NCT ID: NCT05016544 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Advanced Non-small Cell Lung Cancer

Start date: July 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1, open-label study to evaluate the safety and the efficacy of inetetamab in combination with pyrotinib in patients in HER2 mutant or amplified patients with advanced non-small cell lung cancer

NCT ID: NCT05015608 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

SACHI
Start date: November 22, 2021
Phase: Phase 3
Study type: Interventional

This study will look at how effective the study drug(Savolitinib combined with Osimertinib) versus Pemetrexed combined with platinum in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of the first-line EGFR inhibitor therapy.

NCT ID: NCT05015010 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

ALNEO
Start date: May 20, 2021
Phase: Phase 2
Study type: Interventional

Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single deļ¬nitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach. In this trial we want to test in ALK positive stage III locally advanced NSCLC patients, the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence, with a limited risk of toxicity related, in long term administration after surgery.

NCT ID: NCT05014815 Active, not recruiting - Clinical trials for Nonsmall Cell Lung Cancer, Stage IV

Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer

Start date: November 16, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized investigator and participant blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC

NCT ID: NCT05013450 Recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

Dupilumab_Metastatic NSCLC

Start date: September 10, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an Phase Ib/2 study, single arm, single cohort study to determine the safety and tolerability of Dupilumab with PD-(L)1 blockade for patients with relapsed/refractory metastatic NSCLC. For Phase 2, to determine the effect of adding IL-4Ra blockade to PD-(L)1 blocking agents in patients with relapsed/refractory NSCLC, who have progressed on prior PD-(L)1 agents

NCT ID: NCT05012254 Recruiting - Lung Cancer Clinical Trials

Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases

NIVIPI-Brain
Start date: November 18, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, non-randomised, phase II, multicenter clinical trial. 71 stage IV or recurrent, non-small cell lung cancer patients with synchronous brain metastases will be enrolled in this trial to evaluate the efficacy of Nivolumab plus Ipilimumab plus two cycles of platinum-based chemotherapy as first line treatment.

NCT ID: NCT05011487 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

NOCE01
Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer

NCT ID: NCT05010109 Recruiting - Clinical trials for Stage III Lung Cancer AJCC v8

Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

Start date: July 5, 2021
Phase: Phase 1
Study type: Interventional

This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.