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A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) (CLDK378A2112)

Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…

A phase II trial evaluating the safety and efficacy of the addition of concurrent anti-PD-1 nivolumab to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B Non-Small Cell Lung Carcinoma

Primary objective: To assess the feasibility of the addition of nivolumab consolidation to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B NSCLC, as defined by the rate of grade *3 pneumonitis (CTCAE V4.0) 6 months…

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination with Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS and OS in patients with PD-L1- positieve (equal or greater than 25%) NSCLC.To assess the efficacy of MEDI4736 therapy compared to SoC in terms of…

Randomized Phase II, 2-arm study of Pembrolizumab after high dose radiation (SBRT) versus Pembrolizumab alone in patients with advanced non-small cell lung cancer.

Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

Primary Objective* The primary objective of this study is to compare the confirmed objective response rate (ORR) by Week 19 following treatment with bevacizumab-Pfizer in combination with paclitaxel and carboplatin to bevacizumab-EU plus paclitaxel…

[11C]Erlotinib tumor heterogeneity: an in vivo study using static whole body positron emission tomography in non-small cell lung cancer patients.

To evaluate interlesional and intralesional differences in [11C]erlotinib uptake in EGFR mutated (EGFR+) NSCLC patients who are at different stages in their TKI treatment. To correlate tumor [11C]erlotinib uptake to EGFR mutational status, tumor…

Efficacy of a guided self-help exercise program targeting speech, swallowing and shoulder problems in laryngectomized patients: a randomized controlled trial

To investigate the efficacy of the guided self-help exercise program of *in Tune without Cords* among laryngectomized patients.

An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations

Primary• To evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-…

LungTech Stereotactic Body Radiotherapy (SBRT) of inoperable centrally located NSCLC: A phase II study in preparation for a randomized phase III trial

The primary objective of this trial is to assess the effectiveness of IG-SBRT in patients with medically inoperable early stage, centrally located NSCLC and in those who are not willing to undergo surgical treatment.The primary measure of…

Evaluation of 3'-deoxy-3'-[18F]fluorothymidine -PET and diffusion weighted imaging -MRI in patients with early stage non-small cell lung cancer treated with a platinum-based doublet as preoperative chemotherapy.

Primary objectives* 18F-FLT-PET/CT: - To correlate the percentage change in SUV between baseline (SUV-1) and early therapy (SUV-2) with pathological quantification (% of viable tumor cells) of the primary tumor after pre-operative chemotherapy in…

A Phase III open-label, multicenter trial of avelumab (MSB0010718C) versus docetaxel in subjects with non-small cell lung cancer that has progressed after a platinum-containing doublet

To demonstrate superiority with regard to overall survival (OS) of avelumab versus docetaxel in subjects with programmed death ligand 1 (PD-L1) positive (+; as determined by a companion diagnostic test under development), non-small cell lung cancer…

Immunological profiling of hilar and mediastinal lymph nodes in lung cancer patients

We aim to explore the feasibility of immunological cell typing of endobronchial ultrasound (EBUS) guided fine needle aspirates (FNA) of lymph nodes and to develop immunodynamic biomarkers during SABR treatment.

Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations

The primary objective is to evaluate the ability of afatinib to control disease in pretreated patients with advanced non-small cell lung cancer harbouring HER2 exon 20 mutations.Secondary objectives are:* To evaluate secondary measures of clinical…

Respiratory signal driven breathing instructions to improve spatial alignment between respiratory gated PET and breath-hold CT

Is it possible to increase the spatial match between PET and CT imaging with the use of a respiratory instructed breath hold CT?

Comparison of a slowscan ITV, 4DCT ITV/MidV and ABC CT in stage I/II NSCLC patients (IMA study)

Evaluate the differences in the three CT techniques, concerning differences in target volume, dose differences and feasibility. This study will result in an advice which CT technique should be used in the near future, in order to treat the stage I/…

A phase I dose-finding study of bi-daily weekly ModraDoc006/ritonavir as switch maintenance therapy after platinum doublet therapy in patients with non-small cell lung cancer.

* To determine the DLT and the MTD/RP2D of docetaxel as ModraDoc006/ritonavir that can be administered safely to patients with NSCLC in a bi-daily weekly schedule, following platinum doublet first-line treatment.

A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic non-small cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI)

Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…

A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189).

Primary Objective1. To evaluate the antitumor activity of pembrolizumab in combination with chemotherapy compared with saline placebo in combination with chemotherapy using PFS per RECIST 1.1 as assessed by BICR of imaging.2. To evaluate the…

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUNAB (MPDL3280A, ANTI*PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN + PACLITAXEL WITH OR WITHOUT BEVACIZUMAB COMPARED WITH CARBOPLATIN + PACLITAXEL + BEVACIZUMAB IN CHEMOTHERAPY-NAiVE
PATIENTS WITH STAGE IV NON-SQUAMOUS NON*SMALL CELL LUNG CANCER.

Primary Efficacy ObjectivesUnless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + paclitaxel + bevacizumab (Arm B) versus carboplatin + paclitaxel + bevacizumab (…

A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ non*small-cell lung cancer

To demonstrate superiority with regard to Progression Free Survival based on an Independent Review Committeeassessment of avelumab versus platinum-based doublet in NSCLC subjects with PD-L1+