This trial is evaluating whether Pembrolizumab will improve 2 primary outcomes and 23 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Through 90 days post last dose of study treatment (Up to approximately 27 months).
This trial requires 623 total participants across 2 different treatment groups
This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
When you go to the doctor's office to get an X-ray, you could also see a CT scan because they're very similar. The main difference between the CT and the X-ray is the CT has better anatomical resolution and CT should get done first. The CT is the only scan that can show the lungs better than the X-ray. When you see a CT scan it will show the extent and size of all your lungs, as well as any calcifications in your lungs which will be good stuff to know to find any suspicious nodules.
The long-term survival of carcinoma, non-small-cell lung after surgical resection is extremely low (30%). For carcinoma, non-small-cell lung with one or more malignant lesions metastatic at the time of the initial surgery, the long-term survival after resection is significantly improved to 80%.
Carcinoma, NSCLC is defined as a group of malignant tumors that may be carcinoma, SCC, or AC (histopathology type I) of the lung. In clinical trials (whether clinical or in vitro studies) the histopathology type I is usually used in experiments because of the possibility of misinterpretation of results. In recent years, there have been many advances in the pathological diagnosis of carcinoma, NSCLC. In the clinical trials, NSCLC subtypes and the histopathology type are usually recorded in report as a reference for the patients (the patients are not blinded).
Although the epidemiology of this disease is complicated, several risk factors have been associated with an increased likelihood of developing it. In addition, carcinoma of the lung remains a medical mystery, with the precise cause of the majority of cases not known.
The most commonly used treatments for lung cancer are surgery, radiation therapy, and chemotherapy, with surgery most commonly used and surgery most often used for non-small-cell lung cancer. In the United States, most people survive <2 years after diagnosis. Survival after initial diagnosis varies greatly for different subgroups based on gender, race, and age. Women and Blacks have a better survival than men and Whites.
In 2013, 431,534 people in the United States had the diagnosis of carcinoma, non-small-cell lung. Of the total number of cases, there were 246,483 cases of adenocarcinoma, 251,542 cases of squamous cell carcinoma, and 34,926 cases of small cell carcinoma. About 28,000 more cases of carcinoma, non-small cell lung were diagnosed in males than in females. People diagnosed with this type of cancer were more commonly than not middle aged.
Pembrolizumab is occasionally used in combination with several agents, particularly chemotherapy. However, the overall number of patients who would be eligible for pembrolizumab was small. Further prospective trials in larger numbers are needed to confirm and optimize the use of pembrolizumab among patients with solid tumors.
Findings from a recent study shows a strong association between lung cancer and a hereditary basis. A multilocus genetic model is proposed and family linkage in an appropriate case-control design and high-resolution scanning is needed to demonstrate an association.
Surgical therapy is the standard of care for NSCLC. Patients with Stage III malignancy, or Stage III tumors of limited size (<30mmx3 mm), should be considered for active surveillance or clinical trials. Patient age, number of comorbidities, and disease stage can guide patient selection into one of the aforementioned trials.
A significant ( P < 0.0001) proportion of patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab experienced an objective response and survival benefit compared with patients who received chemotherapy alone with or without pembrolizumab. Furthermore, a minority of patients (14 %) experienced treatment-related side effects. In all, patients receiving pembrolizumab had a lower rate ( P < 0.0001) and severity of drug-related skin toxicity and treatment-related fatigue compared with chemotherapy without pembrolizumab. A higher rate ( P = 0.0402) of serious liver toxicity was observed at 3.4 per 10,000 vs.
Pembrolizumab is a novel therapeutical tool in advanced NSCLC. The study confirms the high response rate in treatment-refractory disease. Furthermore, there seems to be an increased incidence of peripheral nervous system events (PNIS); the frequency of this new signal is around 4%, which seems to be higher than the previously described (1%), and may be related to a larger duration of pembrolizumab therapy.
Survival rates for most subtypes of carcinoma, non-small-cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s do not appear to be improving since their initial publication in 1971. Because of the rarity of specific histology as a risk factor for mortality, the data do not preclude the possibility of a substantial improvement in survival for certain histology groups, such as adenocarcinoma. Cancer 2006;122:974-80.