Active clinical trials for "Carcinoma, Non-Small-Cell Lung"

The use of computed tomography (CT) screening has allowed for early detection of lung cancers as small as 5mm in diameter. Early stage cancers are highly curable with a reported survival of greater than 90% over 5 years after surgical resection. Before a patient can have surgery, a biopsy must be performed. One common method is a transthoracic needle biopsy (TTNB). In this procedure, a CT-image is used to locate the area for biopsy. Once identified, the radiologist applies a local anesthetic and inserts an aspiration needle through the ribs, and into the lung tissue. The sampled lung tissue is then sent to pathology. Although this procedure has a diagnostic yield ranging between 70% and 85%, it is associated with serious complications such as pneumothorax, hemoptysis, infection, hemothorax, air embolism and there is about a 20% (range 9%-54%) incidence of pneumothorax, or air leak from the lung, requiring chest tube drainage. Additionally, about 5-15% of cases experience hemoptysis, or coughing blood, although significant life-threatening hemoptysis is only present in less than 1% of patients. When these complications occur, hospitalization as inpatients is required, with an average length of stay of 1-3 days. A new form of technology to localize and biopsy peripheral lung lesions is believed to significantly reduce the amount of complications that can occur during a biopsy. This technology is known as Electromagnetic Navigation Bronchoscopy (ENB). ENB uses electromagnetic tracking and CT-generated virtual bronchoscopy to create a three-dimensional "GPS map" of the lung, guiding the surgeon directly to the tumor. The surgeon is then able to perform bronchoscopy and biopsy the tumor from inside the bronchus. A recent systematic review and meta-analysis of 15 trials reports a pneumothorax rate of 3.1%, with only 1.6% of patients requiring chest tube drainage. Initial studies demonstrate a slightly lower diagnostic yield for ENB as compared to TTNB; however, a systematic exploration of study heterogeneity reveal that lung nodules included in TTNB studies are larger than those included in the meta-analysis of ENB yield. The review further identified six variables associated with increased diagnostic yields for ENB, including "combined use of an ultrasonic radial probe and catheter suctioning as a sampling technique". The superDimension® InReach™ System was granted Health Canada approval on July 23, 2009. There have been no studies directly comparing ENB to TTNB, either retrospectively or prospectively. Initial systematic reviews demonstrate that ENB may have a slightly lower diagnostic yield relative to TTNB. Selection bias and low study quality may have resulted in an underestimation of the true diagnostic yield associated with ENB. The literature also confirms that ENB has a significantly better safety profile as compared to TTNB. As such, a prospective comparison between the two techniques is mandated. This Phase II pilot feasibility trial will utilize randomized methodology to gather the preliminary data that is required for the successful completion of a Phase III randomized controlled trial to compare lung biopsy with ENB verses TTNB. This study will also be the first time ENB lung biopsy is documented in Canada.

This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC) non-small cell lung cancer (NSCLC).

The investigators propose to conduct a retrospective study of single agent ceritinib in patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged adenocarcinoma of the lung with the sole purpose of characterizing the genomic landscape before ceritinib and at the time of disease progression.

This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC (dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal growth factor receptor).

Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver mutations, which when targeted with specific therapies, experience improved outcomes. Unfortunately, identification of these mutations, although recommended in national guidelines, has been limited for a variety of factors including small biopsy samples. The broad application of a sensitive genomic profiling test, which simultaneously examines for multiple genomic alterations on limited biopsy material, could increase the identification of patients with actionable mutations and thereby improve survival in NSCLC. The FoundationOne test meets these requirements. A recent study using the FoundationOne assay identified a significant number of actionable mutations among NSCLC patients who were previously thought to be negative for mutations when tested using other approaches. This is a non-randomized observational comparative study with various cohorts based on physician diagnostic patterns of care and biologic genomic profile status. Survival and cost information will be compared based on different use of genomic profiling.

The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial. The investigators hope to figure out the better chemotherapy regimen for the post-EGFR-TKI failure setting. The primary objective of this trial is to compare progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin and single-agent pemetrexed treatment arms. The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2 arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. Patients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.

This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer. The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.

The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months. At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent. Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups: Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients). Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients). All the patients will be seen according to normal practice by the study medical team. Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.

Lung cancer is the leading cause of cancer death in both men and women in the United States. In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and bronchus, resulting in 159,260 deaths. Per the current National Comprehensive Cancer Network (NCCN) guidelines, the standard of care for early-stage non-small cell lung cancer (NSCLC) is lobectomy with lymph node dissection. Historically, medically inoperable early-stage NSCLC patients have been offered definitive external beam radiotherapy (EBRT) as primary management but, overall, studies have consistently shown poor patient outcomes. Stereotactic body radiation therapy (SBRT) is a technique which delivers very high doses of radiation per fraction over one to five fractions to precisely defined volumes with steep dose gradients. SBRT is commonly utilized for the treatment of biopsy-proven early stage NSCLC in the medically inoperable patient.