This trial is evaluating whether Durvalumab will improve 3 primary outcomes and 24 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of up to 6 months after last dose.
This trial requires 733 total participants across 5 different treatment groups
This trial involves 5 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Carcinoma, non-small-cell lung is the most common lung tumor in men. More than a quarter of the patients with non-small-cell lung carcinoma died. Symptoms and signs were most often related to bulky tumors. The age of the patient was the main factors for predicting the symptoms and signs associated to non-small-cell lung carcinoma patients.
Lung carcinoma is treated primarily based on stage and histomorphopathology. In stage I disease, surgery alone offers the best chance of long-term survival and reduces the chance of developing distant metastases. In stage II disease, surgery does not significantly improve patient survival, but the amount of cancer spread is limited. Radiotherapy or chemoradiotherapy is not normally recommended as first-line treatment unless metastatic spread occurs. Chemotherapy is usually reserved for patients who have developed distant metastasis.
Carcinoma, non-small-cell lung may cause weight loss and, less commonly, symptoms such as headache, cough or dyspepsia. The only sign that distinguishes carcinoma, non-small-cell lung from other causes of mass-like symptoms are increased serum levels of tumour markers. Carcinoma, non-small-cell lung may be associated with enlarged lymph nodes.
Even when carcinoma, non-small-cell lung was definitively cured, some patients presented after a 5-year followup, with significant residual or recurrent disease. Thus, long-term, patient-directed followup will be important to assess patients' treatment successes. A specific and more effective followup strategy needs to be developed for patients with carcinoma, non-small-cell lung.
Non-smokers are at a small increase in SCC risk. The large risk differences between Chinese and North Asian and Caucasians may reflect ethnicity-specific differences in smoking habits.
Despite the high risk of lung cancer, a substantial proportion of lung cancer cases in the United States are not related to asbestos or tobacco smoking, and in the vast majority of such cases they are attributable to environmental tobacco smoke. The use of available screening and diagnostic tests, such as lung scans, chest x-rays, computed tomography of the lungs, and diagnostic bronchoalveolar lavage could potentially detect cases of NSCLC caused by environmental tobacco smoke. We recommend a comprehensive screening program for all people over 45 years of age.
The average age of diagnosis of carcinoma, non-small-cell lung (CSM)-related disease remains remarkably constant at a relatively low age of 80.1 years. The increasing age of lung cancer was almost three-fold greater when compared with the age of people with carcinoma, non-small-cell lung (CSM)-related disease.
Durvalumab is a strong inhibitor of PD-L1, a new class of therapeutic antibody. Because of their common side effects, PD-L1-based antibodies are only prescribed after the exclusion of alternative hypotheses in the development of an immunotherapy, using biomarkers to predict the likelihood of responses.
In May 2014, US Food and Drug Administration granted orphan drug designation for durvalumab and expanded the dosage and the indication to more advanced/uncontrolled disease. In November 2014, US FDA approved in adults with metastatic non-small cell lung cancer (NSCLC) with disease progression following platinum-based chemotherapy (PFS > 6 months). In September 2016 the US FDA approved in adults with locally advanced or metastatic pancreatic cancer (PDC) with disease progression following definitive chemoradiation (dCRT) (post-chemoradiation radiotherapy) followed by a chemotherapy regimen. This approval was based on the SYNTAX study with a survival advantage of 4.
In patients with metastatic NSCLC, no clinically meaningful differences were seen between DTG and durvalumab in the QoL parameters measured (VAS pain/nausea/vomiting, overall pain). Patients with a high baseline VAS and VAS pain/nausea scores were most likely to encounter some change.
It is difficult to come up with an answer from the last 3 years to the question 'What is the latest research for carcinoma, non-small-cell lung?' Because of the small number of reports cited, and due to the limited amount of recent research performed, it is difficult to make any conclusions. More randomized controlled trials are needed, particularly for the treatment of nonfunctioning neuroendocrine tumors.
Durvalumab was well tolerated and demonstrated strong anti-tumor activity in people with various solid tumors. It resulted in substantial and durable reductions in disease burden and was well tolerated.