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Comparative analysis of KRAS and EGFR mutation detection in liquid biopsy vs tissue biopsy in patients with NSCLC

In this study, the agreement between liquid biopsy and tissue biopsy based KRAS/EGFR molecular diagnostics will be determined. Additionally, pairwise comparison of different liquid biopsy based molecular tests will be performed based on several…

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…

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, 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…

Needle based CLE -EBUS guided- for diagnosis and staging of lung cancer

To assess the feasibility and safety of bronchoscopic/endosonography guided needle based confocal laser endomicroscopy patients with suspected or proven lung tumor and/or mediastinal/hilar lymph node metastases

Track and treat in NSCLC (TATIN) - ctDNA guided treatment of early resistance to targeted treatment in patients with EGFR positive NSCLC

Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer

To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by Durvalumab

A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer

The study objectives and endpoints described below will be evaluated for the following treatment regimens:• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance• Arm B: Nivolumab + CCRT followed by nivolumab maintenance• Arm C:…

A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study)

The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…

A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF HE3-DXd IN SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER

This study has been transitioned to CTIS with ID 2024-511205-33-00 check the CTIS register for the current data. Dose Expansion:Primary Objective-*To investigate the antitumor activity of HE3-DXdSecondary Objectives-*To assess the safety and…

Pharmacokinetic boosting of osimertinib in patients with non-small cell lung cancer.

The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…

Cardiac changes after stereotactic radiotherapy for early stage NSCLC cancer or lung metastasis - HALO

We aim to optimize the radiation treatment of early stage lung cancer patients. Cardiac sparing is possible, but it comes at the cost of an increased mean lung dose. Without proof of cardiac toxicity, cardiac sparing will not be (routinely) applied…

Immunological effects of stereotactic radiotherapy - An exploratory trial (iDOSE)

Objective: To identify immunological responses elicited by different schedules of SABR in ES-NSCLC. Expression rates and activation states of immune effector subsets will be assessed in peripheral blood and liquid biopsies (plasma/serum).Hypothesis…

A Phase 3, Randomized, Double blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2022-502658-15-00 check the CTIS register for the current data. Primary Objective• To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A (vs Arm B…

A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients with
BRAFV600-mutant Non-small Cell Lung Cancer

Primary Objective:To evaluate the efficacy of encorafenib + binimetinib in treatment-naïve and previously treated patients with BRAFV600E-mutant NSCLC as measured by ORR.Secondary objectives:1. To evaluate the efficacy of encorafenib + binimetinib…

Utrecht COhort for Lung cancer Outcome Reporting and trial inclusion (U-COLOR)

1) To collect information on patient characteristics, short- and long-term clinical and patient-reported outcomes; and 2) to create an infrastructure for efficient, fast, and pragmatic randomized evaluation of new interventions.

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

This study has been transitioned to CTIS with ID 2024-512667-31-00 check the CTIS register for the current data. Primary objective:- To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients…

A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1* 50%

Primary: To evaluate the efficacy of capmatinib plus pembrolizumab in comparison to pembrolizumab alone. Secondary: * To evaluate the anti-tumor activity of capmatinib plus pembrolizumab in comparison to pembrolizumab alone.* To characterize the…

A Phase 1, Open-Label, Multicenter, Drug-Drug Interaction Study of TAK-788 and Midazolam, a Sensitive CYP3A Substrate, in Patients With Advanced Non*Small Cell Lung Cancer

Primary Objectives:The primary objective of this study is to characterize the effect of repeated oral administration of TAK-788 160 mgQD on the single oral- and IV-dose PK of midazolam.Secondary Objectives:The secondary objective of this study is to…

A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of canakinumab in combination with docetaxel versus placebo in combination with docetaxel in subjects with non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy (CACZ885V2301, CANOPY-2)

Primary: Safety run-in part (part 1):* to confirm tthe recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with docetaxel. Double-blind, randomized, placebo-controlled part (part 2):* to compare the overall survival (OS) between…