
A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers
CarcinomaNon-Small-Cell LungThis is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF-00299804.

Testing a Cognitive Behavioral Model for Reducing Dyspnea in Patients With Lung Cancer
Lung Non-Small Cell CarcinomaLung Small Cell CarcinomaThis trial studies the effect of a form of cognitive-behavioral therapy, Take a Breath, on reducing the intensity and frequency of dyspnea (difficulty breathing) in patients with lung cancer. Take a Breath consists of individual therapy sessions that educate patients on dyspnea and provides coping strategies.

Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients
Extensive Stage Small Cell Lung CancerHealthy11 moreThis randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.

Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer...
Non-Small Cell Lung CancerPulmonary resection surgery is currently the recommended curative treatment for early stages of non-small cell lung cancer. The implementation of preoperative respiratory rehabilitation programs has shown beneficial results on pulmonary function, functional level, cardiorespiratory conditioning and the occurrence and severity of postoperative complications in this population of patients. Despite these benefits, the most recent meta-analyzes highlight the fact that training modalities (duration, frequencies, intensity) are very heterogeneous. It is then difficult to structure a program only on the basis of data from the literature. In a cohort analysis of 50 patients trained from 2014 to 2017, our team reported a significantly greater improvement in physiological parameters in patients who performed 15 or more preoperative training sessions. This number of 15 outpatient sessions is therefore considered a minimum training goal in our current practice. The difficulty of the oncological context is to find the compromise between the necessary diligence to initiate the cancer surgical treatment and the necessary time to obtain the benefits of the preoperative rehabilitation. Previous study reports the difficulty of setting up a four-week training program, perceived as delaying surgery. In order to prevent any risk of prolonging the surgical management time, rehabilitation teams routinely offer short programs with high training frequencies of up to five to six sessions per week. It seems important to note that preoperative rehabilitation is normally considered in patients for whom there is a risk of moderate to high postoperative complications according to the European and North American recommendations. Thus these patients generally benefit from a longer period of assessment than patients whose risk is considered low in terms of their cardio-respiratory and muscular function. The median duration between the physiological evaluation of patients considered "at risk" before pulmonary resection surgery is 44 (Q1-Q3 29-76) days at Rouen University Hospital, with no significant differences observed between patients who have benefited or not from preoperative rehabilitation. Some teams have even pointed out that there is no difference in survival prognosis in the short or long term between patients who have had an operative delay of more or less 60 or 90 days respectively, which shows the compatibility with the set up a dedicated training course. As mentioned earlier, the concept of delay has led to extremely dense training for a functionally and cardio-respiratory fragile target population as evidenced by pejorative VO2peak. The density of the training, failing to generate significant physiological stimulation, may increase fatigue or limit adherence to training, especially if it requires movement, and is added to a therapeutic planning including many consultations and further examinations. To date, no study has evaluated the density of preoperative supervised training on pre-surgical benefits. The objective of this work is to compare the effectiveness of a program of 15 training sessions on VO2peak according to two different densities, namely five times a week over three weeks, or three times a week over five weeks.

Trial Involving Subjects Over 70 Years of Age With Non Small-cell Lung Cancer of Stage IV and Comparing...
Non Small-cell Lung CancerThis is a phase III randomized multicenter study involving subjects over 70 years of age with non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously received chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS) as a screening tool. If the SGS results are normal, the patient will be treated with dual-agent therapy based on platinum (carboplatin + pemetrexed if the histology is non epidermoid, carboplatin + gemcitabin if the histology is epidermoid), with no further geriatric assessment. When the SGS reveals abnormalities, a comprehensive geriatric evaluation (CGE) will be used to define two subpopulations on Balducci's fragility scale, who will receive either monotherapy (docetaxel) or best supportive care. The strategy based on the SGS will be compared with a treatment algorithm based on standard criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified cognitive assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression scale (GDS 5), and screening for a geriatric syndrome defined by the existence of dementia, repeated falls, and urinary and fecal incontinence. The SGS will be validated by comparison with the CGE, that will be administered systematically at enrollment. All the SGS items are included in the CGE. Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL questionnaires), overall survival, the objective response rate, and toxicity. The investigators will also study the predictive power of nutritional indices such as the PINI and the Buzby score with respect to survival, the treatment response, and tolerability.

A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung...
Lung CancerThe goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

Computer-Generated Quality of Life Assessment Program for Advanced Non-Small Cell Lung Cancer Patients...
Non Small Cell Lung CancerIn the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal for oncologists and their patients. In order to achieve this goal, some form of systematic and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of advanced cancer treatments on QoL. The Lung Cancer Symptom Scale (LCSS) is a validated site-specific QoL measure designed for use in patients with lung cancer undergoing treatment. Recently it has been developed into an electronic form that uses a hand-held pocket personal computer (pc) to enhance collection and presentation of QoL assessments into clinical trials and patient care. This study will evaluate the impact of this computer-generated QoL (LCSS-QL) assessment on treatment practices for advanced lung cancer patients using a randomized trial design. The investigators hypothesize that a Computer-Generated Quality of Life Assessment Program will positively impact treatment patterns for patients with lung cancer. Specifically, the investigators hypothesize: Use of the LCSS-QL will increase and accelerate referral to and use of palliative care services; Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with earlier identification of lack of benefit in some patients; Use of the LCSS-QL may decrease the use of imaging tests to assess objective tumor response as an indicator of treatment benefit. Maximizing quality of life is one of the most important goals of palliative chemotherapy in the treatment of advanced lung cancer. If this simple practical tool can be demonstrated to improve palliative management of these patients, including optimizing duration of chemotherapy and use of palliative and supportive services based on patient QoL response, this will dramatically improve the quality of care provided to advanced lung cancer patients. This study will also provide a springboard for other ways to incorporate computer-generated QoL measurement in treatment decision-making in advanced cancer patients, including in other tumor types such as advanced breast and colorectal cancer.

Feasibility of Exercise With Post-Op Lung Cancer Patients
Non-Small Cell Lung CancerPrimary Objective: To examine the effects of an exercise training program on cardiopulmonary fitness in early-stage postoperative non-small cell lung cancer patients undergoing adjuvant chemotherapy Secondary Objectives: Determine patients' adherence levels to such a program during adjuvant chemotherapy Explore the effects of exercise training on treatment compliance and toxicity, and quality of life. To explore the effects of exercise training on markers of inflammation (e.g., c-reactive protein, immune response) in patients undergoing adjuvant chemotherapy for early-stage non-small cell lung cancer

Safety of Adding IMO-2055 to Erlotinib + Bevacizumab in 2nd Line Treatment for Patients With NSCLC...
Non-Small Cell Lung CancerTo evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055 when combined with erlotinib and bevacizumab in patients with previously treated advanced NSCLC.

Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated...
CarcinomaNon-Small-Cell Lung1 moreTo determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.