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NSCLC Stage IV clinical trials

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NCT ID: NCT06374160 Not yet recruiting - NSCLC Stage IV Clinical Trials

Exercise in Patients With Advanced Non-small Cell Lung Cancer

BREATH
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far. The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches. The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.

NCT ID: NCT06313541 Not yet recruiting - NSCLC Stage IV Clinical Trials

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Start date: March 10, 2024
Phase: Phase 2
Study type: Interventional

This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC

NCT ID: NCT06219317 Not yet recruiting - NSCLC Stage IV Clinical Trials

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

ICARS
Start date: October 2024
Phase: Phase 2
Study type: Interventional

This is a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in patients with a stage IV, synchronous, oligometastatic non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of cemiplimab with our without platinum-based chemotherapy and radical treatment. Eligible patients are randomized with a 1:1 ratio to either the cemiplimab or placebo group and will undergo disease assessment (e.g. imaging, blood tests) at regular follow-up visits.

NCT ID: NCT06218940 Not yet recruiting - NSCLC Stage IV Clinical Trials

HY1272 in Patients With Locally Advanced or Metastatic Solid Tumors or Locally Advanced or Metastatic EGFRm+ NSCLC

Start date: December 1, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multicenter, dose escalation study of HY1272 (administered via IV) evaluating both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in patients diagnosed with locally advanced or metastatic solid tumors (monotherapy) or locally advanced or metastatic EGFRm+ NSCLC (combination therapy). The study is designed to evaluate safety, tolerability, PK, and anti-tumor activity of HY1272 administered once weekly. Patients in the monotherapy portion of this study will receive only HY1272. Patients in the combination therapy portion of this study will receive osimertinib administered once daily (QD) with HY1272.

NCT ID: NCT05859217 Not yet recruiting - Lung Cancer Clinical Trials

A Study of Combining Cabozantinib and Atezolizumab for Advanced/Metastatic NSCLC (Cabatezo-1)

Cabatezo-1
Start date: December 2023
Phase: Phase 2
Study type: Interventional

NSCLC patients with low expression level of PD-L1, esp. those with its level less than 1%, do not derive much benefit from anti-PD-1/L1 therapy (e.g. atezoilzumab). In this study, investigators hypothesize that the combination of cabozantinib (a multi-kinase inhibitor) and atezolizumab will result in better therapeutic value.

NCT ID: NCT05597800 Not yet recruiting - HIV Clinical Trials

Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome

LUNGVIR
Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV/HCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome (Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).

NCT ID: NCT05543330 Not yet recruiting - NSCLC Stage IV Clinical Trials

A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC

Start date: September 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/phase 2, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of M701 in patients with treatment of malignant pleural effusions caused by NSCLC.

NCT ID: NCT04613804 Not yet recruiting - NSCLC Stage IV Clinical Trials

Toripalimab as Maintenance Therapy in Patients With Driver-gene Negative Advanced NSCLC After First-line Chemotherapy

Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

Lung cancer is the malignant tumor with the highest incidence and mortality in China. Non-small cell lung cancer (NSCLC) ,which includes non-squamous cell carcinoma (including adenocarcinoma, large cell carcinoma, and other cell types) and squamous cell carcinoma, accounts for about 80% of lung cancer. Platinum-based two-drug chemotherapy is the first-line standard treatment for driver-gene negative advanced NSCLC, but most patients experience disease progression after 4 to 6 months. To extend the efficacy of first-line treatment, maintenance therapy is a logical clinical option for patients who are effective after 4 to 6 cycles of standard treatment. There is currently no standard regimen for maintenance treatment of NSCLC. We evaluated the effectiveness and safety of maintenance therapy with the anti-PD-1 monoclonal antibody (Toripalimab injection) followed by the first-line standard regimen in advanced NSCLC patients who are effective after standard treatment. With a view to exploring treatment methods that are effective for the maintenance treatment of driver-gene negative advanced NSCLC and have little toxic and side effects,thereby improving the survival prognosis of these patients.

NCT ID: NCT04604470 Not yet recruiting - Lung Cancer Clinical Trials

Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2

I-SABR2_PDA
Start date: October 20, 2020
Phase:
Study type: Observational

This is a trial-specific (NCT03705403) decision aid (tPDA) for stage IV NSCLC patients that might want to participate. We want to investigate if a tPDA would be (significantly) helpful for these patients in making a decision. ImmunoSABR has a complex study design, we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together. (text, video, questions, pictures, timelines, etc.)

NCT ID: NCT04492969 Not yet recruiting - NSCLC Stage IV Clinical Trials

Prospective Observation of Failure Patterns in NSCLC Treated With ICIs

Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.