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Lung Neoplasm Malignant clinical trials

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NCT ID: NCT04036721 Suspended - Clinical trials for Interstitial Lung Disease

Coorticosteroid Regimen in Patients With Anti-PD-1/PD-L1 Induced Pneumonitis

PROS-CONS
Start date: October 1, 2019
Phase: Phase 4
Study type: Interventional

This is a prospective interventional open-label randomized trial. The patients treated with anti- PD-1 (programmed-death receptor type 1) or anti-PD-L1 (programmed-death ligand) antibodies in case of new acute onset interstitial changes or new seriuos respiratory system related symptoms will be recruited for this study to perform diagnostics. At the recruitment the patient will be randomized 1:1 to investigatory or control arm, the randomization will be stratified upon three criteria: 1. severity of suspected pneumonitis at baseline (grade 2 vs. grade 3-4) 2. response for oncological treatment (partial response (PR) and complete response (CR) vs. stable disease (SD) and progression disease (PD)) 3. chronic respiratory system disorders Both groups will be treated in the same way in terms of diagnostic procedures. In case of interstitial lung diseases related to immune checkpoint inhibitor is confirmed with the severity of grade 2-4 in the modified CTCAE criteria the patient will get the treatment, accordingly to the randomization: ARM A - INVESTIGATORY GROUP the start dose will be 1-4 mg/kg of body weight of prednisone, depending on clinical condition and pneumonitis severity, the induction treatment will last for 5-7 days, in case of severe condition - no improvement after 48-72 h of initial treatment - introduction of immunosuppressive agent is recommended - cyclophosphamide, mofetil mycophenolate or infliximab. A continuation treatment with dose tapering is than recommended, starting from 60mg q 24h of prednisone for 2-4 weeks, and dropping the dose 10mg q 24 h not faster than over 14 days; the maintenance dose of prednisone 10mg q 24 h should be hold for 8 weeks and withdraw should last for 4 weeks. This arm will be treated with corticosteroid for at least 12-24 weeks. ARM B - CONTROL GROUP the starting dose will be 1-4mg/kg of body weight of prednisone , depending on clinical condition and pneumonitis severity, the induction treatment will last 5-7 days; in case of severe condition - no improvement after 48-72 h of initial treatment - introduction of immunosuppressive agent is recommended: cyclophosphamide, mofetil mycophenolate or infliximab. A continuation treatment with dose tapering is than planned, starting from oral dose of 30-60mg q 24h of prednisone, and dose reduction of 10mg q 24 h each 1 week. This arm will be treated for 6-12 weeks. During the treatment and after its termination the function of respiratory system, interstitial changes in radiologic examinations, anticancer response, survival time, pneumonitis relapse and glucocorticosteroid side effects will be monitored and evaluated. The observation will last up to 52 weeks.

NCT ID: NCT03834116 Completed - Clinical trials for Lung Neoplasm Malignant

Resistance Inspiratory Muscle Training for Patients With Thoracic Malignancies

Start date: November 23, 2019
Phase: N/A
Study type: Interventional

A small-scale pilot randomized controlled trial conducted by the investigators demonstrated some preliminary evidence that inspiratory muscle training (IMT) could be a promising self-management method for alleviating breathlessness. Hence, the aim of this study is to assess the effectiveness of IMT in patients with thoracic malignancies on dyspnea.

NCT ID: NCT03824977 Completed - Clinical trials for Lung Neoplasm Malignant

Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery

PREOTEST
Start date: November 21, 2018
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to evaluate the performances of the Six-Minute Stepper Test (6MST) and Sit To Stand test (STST) to predict post-operative complications after minimally invasive lung cancer resection.

NCT ID: NCT03525782 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

Start date: February 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer.

NCT ID: NCT03352245 Completed - Clinical trials for Lung Neoplasm Malignant

Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of >50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.

NCT ID: NCT02985203 Terminated - Clinical trials for Lung Neoplasm Malignant

Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer

Start date: November 2016
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer. The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B).