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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 randomised open-label phase II trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy

The primary objective is to evaluate if patients treated with chemo-radiotherapy and prophylactic cranial irradiation followed by consolidation treatment (nivolumab plus ipilimumab) have a better outcome in terms of progression-free survival (time…

Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study)

Primary: To assess PFS of lung cancer patients with an FGFR1 gene amplified in their tumor cells upon treatment with BIBF1120.Secondary: To assess response rate, duration of response, overall survival and safety.

A Randomized, Controlled Phase 2 Study Evaluating LY2875358 plus Erlotinib versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Activating EGFR Mutations Who Have Disease Control after an 8-Week Lead-In Treatment with Erlotinib

The primary objective of this study is to compare PFS with LY2875358 plus erlotinib therapy with erlotinibmonotherapy as first-line treatment in metastatic NSCLC patients with activating EGFR mutations who havedisease control after an 8-week lead-in…

A phase II multicenter, single-arm study of MPDL3280A in patients with PD-L1 positive locally advanced or metastatic non small cell lunch cancer

The primary efficacy objective for this study is to evaluate the efficacy of MPDL3280Ain patients with PD-L1*positive locally advanced or metastatic NSCLC, as measuredby investigator-assessed ORR according to modified RECIST.SECONDARY OBJECTIVESThe…

A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer (CEGF816X2201C)

Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…

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 randomized phase II study of paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV non-squamous-non-small cell lung cancer: NVALT12

The addition of NTG patches to bevacizumab containing chemotherapy (experimental arm) improves PFS in patients with stage IV non-squamous NSCLC, compared to bevacizumab containing chemotherapy without NTG (control arm)Secondary Objectives: Objective…

Stereotactic Radiotherapy for Metastasis to the Lung

To determine whether SRT achieves a local control rate comparable to surgery in patients with metastatic lung disease.

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…

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…

Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a "sensitive" relapse

To assess the therapeutic activity of SU11248 in patients with exptensive disease small cell lung cancer who are either chemonaive or have a sensitive relapse

A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Primary Objective:Part 1: To identify a dose of AMG 479 in combination with etoposide plus carboplatin and/or etoposide plus cisplatin, and of AMG 102 in combination with etoposide plus carboplatin and/or etoposide plus cisplatin that can be…

F-FDG PET as an Early Response Parameter in Stereotactic Body Radiotherapy for stage I-II (T1-T3, N0) Non Small Cell Lung Carcinoma: A Pilot Study

The objective of the present study is to investigate whether a metabolic response as assessed by 18F-FDG PET can be observed after the first fraction of SBRT. This study will contribute to establishing the role of definitive SBRT in the treatment of…

An open label two-stage study of orally administered BKM120 in patients with metastatic non-small cell lung cancer with activated PI3K pathway.

The purpose of this prospective, multi-center, open-label, two-stage phase II study is to assessthe efficacy of BKM120, as measured by determining the PFS, in patients with pretreatedmetastatic NSCLC that exhibits PI3K pathway activation. BKM120…

A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared with Docetaxel in 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (MEK114653)

Primary: progression-free survival in the GSK1120212-group in comparison with the docetaxel group. Secondary: safety and tolerability, response rate, duration of response, overall survival, PK.

A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment (CAUY922A2207)

Primary: Progression Free Survival (PFS) in patients treated with AUY922 versus pemetrexed or docetaxel.Secondary: Overall response rate, disease control rate, overall survival, safety and tolerability, PK.

A Single-Arm, Multicenter, Open-Label, Phase 2 Study of;Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab;(IMC-11F8) in the First-Line Treatment of Patients With;Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous…

A phase II study of gefitinib and fulvestrant in patients with advanced EGFR mutated non small cell lung cancer pretreated with reversible EGFR tyrosine kinase inhibitors

2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…

A phase II, multi-center, open-label study of AUY922 administered i.v. on a once-weekly schedule in patients with advanced non-small-cell lung cancer who have received at least two lines of prior chemotherapy

Primary objective* To estimate efficacy for each study stratum at 18 weeks as assessed by RECISTKey Secondary objectives:* To estimate overall survival (OS) and progression free survival (PFS) in patients with advanced NSCLC* To determine safety and…