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Clinical Performance Study Protocol for Use of the [redacted] PD-L1 [redacted] CDx Assay: Evaluation of PD-L1 Expression Levels in Non-small Cell Lung Cancer Specimens from Phase III Study [redacted]

The primary objective of this study is to evaluate the clinical performance of the [Redacted] PD-L1 [Redacted] CDx Assay in terms of its ability to identify patients with non-squamous metastatic NSCLC (mNSCLC) who may benefit from treatment with […

Proteogenomic approach to reveal age-specific molecular mechanisms of laryngeal squamous cell carcinomas

Identify molecular differences in carcinogenesis of LSCC between younger and elderly patients through an integrated proteogenomic analysis of laryngeal tissue biopsies that could optimize personalized treatment of elderly patients in particular.

A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC

The primary objective is to assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1. The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free…

A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and
Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects…

A Phase II, multi-center, open-label, five-arm study to evaluate the efficacy and safety of oral ceritinib treatment for patients with ALK-positive non-small cell lung cancer (NSCLC) metastatic to the brain and/or to leptomeninges.

The primary objective is to evaluate the antitumor activity of ceritinib in patients with ALK-positive NSCLC metastatic to the brain and/or toleptomeninges based on whole body overall response rate (ORR), defined as the proportion of patients with a…

Imaging in Lifelines

The Imalife study aims to assess reference values of lung density, bronchial wall thickness, vascular calcification and lung nodules by quantitative low-dose CT. Secondarily, it aims to assess the relation of quantitative imaging biomarkers of the…

Lung cancer Early Molecular Assessment trial

Primary Objective:- To determine the percentage of patients with EGFR mutation, ALK translocation and other genetic aberrations with an improved efficacy of molecular profiling in all stages of NSCLC.- To determine PD-L1 tumour proportion score in…

A Phase III, Open-label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination with Tremelimumab, Determined by PD-L1 Expression, Versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB IV) who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…

Phase I Study: safety and immunogenicity of vaccination with XAGE1B long peptides combined with
poly-ICLC in patients with pulmonary adenocarcinoma

Primary objective:* To evaluate the safety of vaccination with XAGE1B peptides emulsified in Montanide ISA 51 co-mixed with the adjuvant Hiltonol® (Poly-ICLC) in patients with pulmonary adenocarcinoma.Secondary objective* To evaluate the capacity of…

A Phase I, Open-label, Non-randomised Study to Assess the Effect of
Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral
Dose of AZD9291 in Patients with EGFRm Positive NSCLC Whose Disease
has Progressed on an EGFR TKI

To investigate the effect of a CYP3A4 inhibitor (itraconazole) on the PK of AZD9291.

A randomized phase III study of monotherapy docetaxel or intercalated erlotinib docetaxel combination therapy in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma. (NVALT 18 study)

The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.

Fluid phase biopsy (circulating tumour DNA and serum tumour markers) in
patients with non-small cell lung cancer.

In advanced NSCLC & in first stage of study in locally advanced NSCLC:To assess the kinetics of STMs and ctDNA in plasma before, during and after treatment for NSCLC.Second stage of study in locally advanced NSCLC:To determine the prognostic…

NL NVALT2017 / Translational research for immune modulating and targeted therapy in non-small cell lung cancer, an exploratory NVALT study

* To explore baseline predictive biomarkers for tumor response to immune modulating and targeted treatment in patients with NSCLC.* To develop biomarkers of therapy resistance to anti-PD-1 treatment in patients with NSCLC.* To explore patterns of…

Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…

A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) after Completion of Platinum-based First Line Chemotherapy

The aim of the study is to compare overall survival (OS) and Blinded Independent Central Review (BICR)-assessed progression free survival (PFS), of nivolumab, and nivolumab in combination with ipilimumab, versus placebo in subjects with ED-SCLC…

A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Non-Small Cell Lung Cancer

1) Objective: To compare the overall survival (OS) of previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel.2) Objective: To compare progression-free survival (PFS) per RECIST 1.1 by…

MicroRNA profiles in blood and urine in lung cancer: a pilot study

The primary objective of this study is to compare the profile of MicroRNA*s in the urine and blood of lung cancer patients with the profile of MicroRNA*s in the urine and blood of non-lung cancer patients with similar symptoms and with that of…

The benefit of ultra-high resolution computed tomography: Precision of repeated volume measurements of pulmonary nodules

To assess the variability of semi-automated volume measurements of pulmonary nodules in patients with known or suspected pulmonary metastases on same-day repeated scans of equal radiation dose from two different CT scanners: CT scanner with standard…

CA209-759: Blood-borne biomarkers for tumor response to Nivolumab in KRAS-mutated non-small cell lung cancer, an exploratory study

Predictive value of patient specific KRAS mutation in ctDNA in serial blood samples (trajectories) and a durable clinical response to nivolumab.

CA209-762: Pilot study of fine needle aspiration (EUS/EBUS) versus histology for PD-L1 staining in lung cancer, a pilot study.

The primary objective for this study is to explore the options for a minimally invasive predictive test for selecting patients for the treatment with an anti-PD1/PD-L1 treatment. The secondary objective is to explore for which patients with PD-L1…