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Treatment of larger tumor volumes or >= 2 lung tumors simultaneously in lung cancer patients using SBRT in a mean-lung dose escalation study

Primary objective: the assessment of the maximal mean lung dose that is accepted to safely treat large peripheral tumors or 2 lung metastases simultaneously using SBRT. Secondary objectives:- evaluation of local control - evaluation of regional…

A Randomized Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma

Primary Objectives* Compare OS in NSCLC patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel aloneSecondary Objectives* Compare progression-free survival (PFS) between the 2 treatment arms*…

ImmunoModulation by the Combination of Ipilimumab and nivolumab neoadjuvant to Surgery In advanced Or recurrent Head and Neck Carcinoma, (IMCISION), a phase-Ib/II trial. Subtitle: Hypoxia as a determinant for the effect of nivolumab with or without ipilimumab on intra-tumoral T cell capacity

Herewith, we present a research protocol that allows us to examine feasibility and safety of checkpoint blockade neoadjuvant to standard of care (SOC) in a patient population in need for improved clinical outcome and in tumors likely to respond to…

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…

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis

Primary objective:To evaluate the effect of each of 2 doses of AK001 separately in combination with an INS versus the INS alone on the reduction in size of nasal polyps as evaluated by the change from Baseline to Week 12 after the start of treatment…

A phase II, multicenter, single-arm study of oral LDK378 in adult patients with ALK-activated non-small cell lung cancer previously treated with chemotherapy and crizotinib

The primary objective of the study is to demonstrate the antitumor activity of LDK378.

Iressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment. NVALT 16

The primary objective of this study is to evaluate the disease control rate (DCR; confirmed complete response (CR) or partial response (PR), or stable disease (SD)) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.…

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…

Ipilimumab plus Nivolumab and ChemoRadiotherapy followed by Surgery in patients with resectable and borderline resectable T3-4N0-1 NSCLC

Primary objective:• To assess the safety and feasibility of adding ipilimumab-nivolumab to a CRT induction protocol• To assess the efficacy of adding ipilimumab-nivolumab to CRT on the likelihood of a pCR and MPRSecondary objectives: • Local and…

A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

The primary objective is to assess treatment with rovalpituzumab tesirine improves overall survival rate (OS) compared to topotecan in subjects with DLL3high SCLC who have first disease progression during or following front-line platinum based…

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN + PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN + PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

The co-primary objectives of this study are: * To evaluate the efficacy of as measured by investigator-assessed PFS according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). * To evaluate the efficacy of atezolizumab as…

Re-induction of a systemic immune response after initial response with immune therapy with radiotherapy in metastatic or locally recurrent lung cancer

To investigate the progression-free survival after radiotherapy to a single lesion in patients with stage IV non-small cell lung cancer who achieved at least stable disease with immune therapy alone or concurrent immune therapy and chemotherapy and…

A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III)Who Have Not Progressed Following Definitive, Platinum-based,Concurrent Chemoradiation Therapy (PACIFIC)

The primary objective of this study is to assess the efficacy of MEDI4736 treatment compared with placebo in terms of overall survival (OS) and progression free survival (PFS; (per RECIST 1.1 as assessed by the investigator).

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 multicenter, open label non-randomized phase I/II dose escalation study with extension cohort to determine the safety, tolerability and immune modulating effects of the therapeutic LRPAP1 synthetic long peptide ( LRPAP7-30V-SLP) vaccine (TEIPP24) at different doses in HLA-A*0201-positive patients with non-small cell lung cancer (NSCLC).

Primary objectives- A multicenter, open label non-randomized phase I/II dose escalation study with extension cohort to determine the safety, tolerability and immunogenicity of the therapeutic LRPAP1 synthetic long peptide ( LRPAP7-30V-SLP) vaccine (…

A Phase III, Open Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma

The primary objective of this study is to compare the overall survival (OS) associated with rAd-IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM…

A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer

To establish the efficacy and safety of nivolumab administered as a flat dose in combination with weight-based ipilimumab dosing.

A randomised phase II trial of osimertinib and bevacizumab versus osimertinib alone as second-line treatment in stage IIIb-IVb NSCLC with confirmed EGFRm and T790M

Primary objectiveTo assess the efficacy of the combination of osimertinib and bevacizumab versus osimertinib alone in terms of progression-free survival (PFS) assessed by RECIST 1.1.Secondary Objectives:To compare short and long term clinical…

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 (…