View clinical trials related to Carcinoma, Non-Small-Cell Lung.
Filter by:RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.
This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule. The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy. The combination of cisplatin/pemetrexed has come to be recognized as the new standard of care for patients with untreated, unresectable malignant pleural mesothelioma (MPM) and untreated NSCLC non-squamous cell histology. Preclinical and clinical findings that support this protocol are: - CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines. - Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines. - The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination, given that hematological toxicity and gastrointestinal toxicity are the principal toxicity types of the latter. - Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated that the addition of CBP501 to this combination can be evaluated without excessive risk in the phase II programs. - The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and pemetrexed 500 mg/m² is currently in use in the phase II study with first line mesothelioma patients. - Hints of activity were observed during the phase I study with CBP501 and cisplatin. - No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.
The investigators performed a multicenter, open trial of using TS gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.
Dose finding part: A phase I clinical trial to evaluate the safety of combined sorafenib and everolimus treatment in patients with relapsed solid tumors (finished). Extension part:Treatment of non-small cell lung cancer (NSCLC) with KRAS mutation after ≥ 1st relapse (recruiting)
This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
This is a multi-center, randomized, blinded, two-period, two-sequence, crossover study, with a minimum 3-week washout period between treatments.The study is designed to evaluate the bioequivalence of SID530 to Taxotere. It will be conducted in study participants with locally advanced or metastatic NSCLC who have failed platinum therapy and also in participants with locally advanced or metastatic breast cancer who have failed at least one line of chemotherapy. Eligible study participants must be planning to have at least two consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy. The duration of study participation will be approximately 7 weeks. The study has three study phases: Screening (<=1 week), Cycle 1 (21 days), and Cycle 2 (21 days).
Background: - The Lung Cancer section of the National Cancer Institute s Medical Oncology Branch is running a study to better understand which genes might be important in patients who are undergoing therapy for lung cancer. Objectives: - To find out if differences (also called polymorphisms) in specific genes lead to differences in outcomes (such as treatment success and survival rates) for patients who have been diagnosed with lung cancer. - To establish a repository of genetic information for future studies of these differences and their relation to lung cancer. Eligibility: - Any individual who has been diagnosed with lung cancer and is being treated through the National Cancer Institute. Design: - After entrance in this study, patients will provide information to the researchers on age, gender, race/ethnicity, treatments received and response to treatments, and other specific information about their disease. This information will be kept confidential. - Approximately half a tablespoon of blood will be drawn. - Patients will be treated for lung cancer with normal treatment methods, as if they had not been enrolled in the study - Some patients may be offered the option of enrolling in separate research protocols for cancer treatment, involving chemotherapy, surgery, or radiation.
Background: More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment. Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in body secretions such as breast milk, tears and saliva. In previous studies, talactoferrin improved life span in patients with NSCLC without causing toxic side effects. Objectives: To examine the effects of talactoferrin on the immune system and determine its effectiveness in treating NSCLC. Eligibility: Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse following at least one course of treatment. Design: Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks, followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on the drug side effects and the response of the tumor. Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital signs and blood tests every 3 weeks. CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6 weeks and 12 weeks and then every 12 weeks during the duration of treatment. Apheresis: Quantities of white blood cells called lymphocytes are collected through a procedure called apheresis in order to measure the immune response to treatment. In this procedure, blood is collected through a needle placed in a vein in the arm (similar to donating blood) and circulated through a cell separator machine. The lymphocytes are extracted and the rest of the blood is returned to the body through the same needle.
Background: - The drug R935788 (fostamatanib disodium) is a kinase inhibitor (i.e., it interferes with cell communication and growth and may prevent tumor growth). - R935788 has shown promising activity in NCI-60 (a panel of 60 diverse human cancer cell lines) against colon cancer, non-small cell lung cancer, and renal cell carcinoma cell lines, as well as in two renal cell xenograft models. - This is an open-label, Phase II study of R935788. Phase I studies in patients with immune thrombocytopenic purpura, rheumatoid arthritis, and lymphoma have demonstrated safety with a continuous dosing schedule, and a maximum tolerated dose has been established. Objectives: - To test an experimental drug called R935788 (fostamatinib disodium) for its ability to stop cancer growth signals, thus slowing the growth of cancer cells in laboratory testing. - To determine the clinical response of R935788 administered orally twice a day on a continuous schedule in patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid cancer, non-small cell lung cancer, hepatocellular, carcinoma of the head and neck, and renal cell carcinoma. - To evaluate the effects, safety, and biochemical response of R935788 therapy. Eligibility: - Patients with colorectal carcinoma, pheochromocytoma, follicular or papillary thyroid cancer, non-small cell lung cancer (excluding squamous cell histology), hepatocellular cancer, carcinoma of the head and neck, and renal cell carcinoma whose disease has progressed after any therapy or who have no acceptable standard treatment options. - Patients must have recovered from toxicities of prior therapies to at least eligibility levels. - Patients who have received radiation or chemotherapy within 4 weeks of study enrollment are not eligible. - Women who are pregnant or breastfeeding are not eligible. Design: - Researchers will conduct the following tests and procedures during the study: - Clinic visits with a physical exam, including vital signs and blood pressure, every other week during cycle 1, and once a month starting with cycle 2. - Blood will be drawn weekly during cycle 1, every other week during cycle 2, and once a month starting with cycle 3; urine tests will be conducted depending on results of blood tests. - Imaging tests, such as computed tomography (CT) scans (a series of x-rays) or ultrasound (an examination using sound waves), will be done every 8 weeks while the patient is receiving R935788. - R935788 will be administered orally twice a day for 28 days (one cycle). Imaging studies will be obtained every two cycles. Patients will fill in a diary to show when they took the medication and to note any side effects. The 28-day treatment cycle will be repeated as long as the patient is tolerating R935788 and the cancer is either stable or getting better. - Researchers will conduct the following additional tests to see how the study is affecting the patient: - Other research blood samples will be collected before treatment, at cycle 1 week 3, at the beginning of cycle 2, and at 8 weeks. - Optional tumor biopsies will be requested before starting treatment, at cycle 1 day 28. - Patients with specific lesions or tumors may be asked for an optional tumor biopsy on day 8.