This trial is evaluating whether V941 will improve 3 primary outcomes, 2 secondary outcomes, and 1 other outcome in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Cycle 1 (Up to 21 days).
This trial requires 100 total participants across 2 different treatment groups
This trial involves 2 different treatments. V941 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
For lung cancers, v941 is equally effective compared to the benchmark treatment regimen of carboplatin plus paclitaxel. The mechanism of action of v941 may be related to increased apoptosis and reduction of angiogenesis.
Each year, 100,300 people are diagnosed with carcinoma, non-small-cell lung, in the United States. About 7% of these patients die. Most people with carcinoma, non-small-cell lung can be treated with surgery. About 6% of the patients develop lung metastasis at the time of the first diagnosis. About 26% of the patients will die within two years.
The carcinoma, non-small-cell lung is caused by abnormal DNA, protein, and metabolism of an affected patient. Many factors influence carcinoma, non-small-cell lung occurrence including family history, environmental exposures.
The present study has shown the importance of looking for lymph node metastases and signs of invasion in carcinoma, non-small-cell lung. The lymph node ratio is useful in the evaluation of the extent of disease. It can be useful in making decisions on further treatment in combination with other investigations.
Treatment of carcinoma, non-small-cell lung is dependent upon the stage of the disease: early, localized stages (stages IA and IB with only one lymph node metastasis) are treated with surgery, and later stages (stages II, III, IV; two or three metastatic lymph nodes) are treated with chemotherapy, radiation therapy, and surgery. The five-year survival for carcinoma, non-small-cell lung is 5% for stage IA, 30% for stage IB, 59% for stage II, and 69% for stage III and IV. Treatment with chemotherapy and/or radiation and for early cancer treatment often results in complete remission of the cancer.
Results from a recent clinical trial indicate the following factors to be important in assessing prognosis, treatment decisions, and survival for lung carcinoma patients who present at diagnosis: (1) age, sex, stage, and performance status; (2) presence or absence of distant metastases; (3) whether surgery, chemotherapy, or combined modality therapy is offered; (4) number of involved sites; (5) radiographic evidence of local/regional recurrence; and (6) systemic disease burden, as expressed by number of involved sites, serum CA 19-9 level, and elevated CEA. The prognostic significance of number of involved sites is most marked at all stages except stage IA.
In a small number of patients a good prognosis can be achieved by a well-established multi-component system with the goal to prevent occurrence of recurrent or metastatic disease and therefore prolong survival.
In the light of these findings, the FDA could well be re-examining its regulatory policies on gene-silencing agents. The FDA's apparent reluctance to label and market gene-silencing technologies may be due to concern over the risk of 'off-label' gene silencing usage, which in the worst-case scenario could lead to a 'genetic time bomb' (or 'epigenetic time bomb') in the form of an intersex'mutant-phenotype' (i.e., 'human-genome-crossing') individual, with consequent lifelong health risk to members of his/her family or other intersex members, if they happen to live to old age.
The use of monoclonal antibodies in cancer research has led to the development of new therapies for various cancer types, and this trend may soon reach lung cancer. The monoclonal antibodies targeting CD20 and CD30 may be the best choice in the second-line therapy for patients with non-small cell lung carcinoma.
This information may provide clinicians and patients with a more thorough understanding of the disease process and treatment options, as well as aid in guiding patient-family discussions of end of life care.
[The percentage of patients who develop carcinoma, non-small-cell lung, from the general population] was (1.15 x 0.83) = 1.38. Taking the data at 1 year, this gives an expected probability of carcinoma, non-small-cell lung, of 4.9%. [This calculation helps to determine if there is a need to perform preventive screening for this disease] (P<0.05). Power makes it easy to find trials tailored to the needs of your condition, treatment, or location.
The most well-known patient with v941 was a child with retinoblastoma, and clinical trials may not be appropriate treatment for all patients with v941-positive cancers. We recommend that patients with v941-positive cancer do not participate in cancer clinical trials without a more appropriate trial involving v941. A small number of clinical trials on v941 are still ongoing, however more studies investigating the effectiveness and safety of v941 in patients with carcinoma may be the future direction for clinical trials with v941.