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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.

An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in combination with Ipilimumab in Subjects with Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC)

Primary objectives - To evalulate the association between baseline tissue TMB/blood TMB and clinical efficacy (Objective Response Rate) for participants in Part 2- To evaluate the correlation between baseline tissue TMB and blood TMB for…

A Phase 2 Study of Poziotinib in Patients with Non-Small Cell Lung Cancer (NSCLC),
Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)

Objectives:To evaluate the following in NSCLC patients with EGFR or HER2 exon 20 insertion mutations (includingduplication mutations) who are treated with poziotinib:Primary Objective:Objective Response Rate (ORR)Secondary Objectives:• Disease…

Microbiome Intervention in Late-stage metastatic Lung cancer patients to improve response rate to immunotherapy

Investigate the effect of FMT from healthy obese donors on objective response rate (ORR according to RECIST criteria) in patients with metastasized or locally advanced NSCLC receiving standard of care first-line immunotherapy with or without…

Clinical Performance Study Protocol for Use of the [REDACTED] PD-L1 [REDACTED] CDx Assay: Evaluation of PD-L1 Expression Levels in Non-smallCell 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 squamous metastatic NSCLC (mNSCLC) who may benefit from treatment with […

Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a proof of principle study

This study aims to investigate proof of principle of utilizing nCLE during CBCT-NB navigation bronchoscopy. A confirmatory CBCT spin is considered the gold standard for tool-in-lesion but is associated with additional radiation exposure. We aim to…

A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients with EGFR Mutant Non-Small Cell Lung Cancer

Phase 1• To determine the maximum tolerated dose (MTD) and RP2D of BLU 945 as monotherapy and in combination with osimertinib• To determine the safety and tolerability of BLU 945 as monotherapy and in combination with osimertinibPhase 2• To assess…

Prospective primary human lung cancer tumoroids to predict treatment response

To establish matched normal and primary human lung cancer organoids from patient-derived lung (tumor) material.

A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of rilvegostomig (AZD2936) Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01)

This study has been transitioned to CTIS with ID 2023-508262-15-00 check the CTIS register for the current data. Part D dose expansion:- To assess safety and tolerability of AZD2936 (rilvegostomig) in CPI-naive participants with stage IV NSCLC with…

A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

This study has been transitioned to CTIS with ID 2023-508922-83-00 check the CTIS register for the current data. Primary Objective:To evaluate the efficacy of adagrasib monotherapy and in combination with pembrolizumab administered in the first-line…

A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreaK 201)

Primary- To evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in subjects who receive sotorasib at either 960 mg daily (QD) or 240 mg QD whose tumors are PD-L1 Tumor…

Detection of sentinel lymph nodes in laryngeal cancer by injection of 99mTc-nanocolloid via flexible laryngoscopy as a new technique

Primary Objective: The feasibility of injecting 99mTc-nanocolloid via a flexible laryngoscope with a working channel and subsequent detection of SLN will be evaluated.Secondary Objective: Preoperative located SLN via gamma camera imaging will be…

HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

This study has been transitioned to CTIS with ID 2024-512238-13-00 check the CTIS register for the current data. Primary objective: 1. To investigate the antitumor activity of patritumab deruxtecan in subjects with metastatic or locally advanced…

rEaL-world pharmacokinetics of Immune Checkpoint InhibiTors (ELICIT)

To determine the real-world pharmacokinetics of ICIs.

A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with Activating EGFR or HER2 Mutations

This study has been transitioned to CTIS with ID 2023-508349-42-00 check the CTIS register for the current data. Stage 1 Primary ObjectiveTo evaluate the safety and tolerability, determine the expansion dose, and characterize dose-limiting…

Improving Standard of Care lifestyle support for stage III NSCLC cancer patients

By an early-initiated personal, supportive care program prevent deterioration of performance status (=WHO 0 or 1) in at least 90% of patients with NSCLC stage III, as determined by the patient itself, at the start of immunotherapy.

KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression >= 1% and an STK11 co-mutation.

This study has been transitioned to CTIS with ID 2024-511708-18-00 check the CTIS register for the current data. the Sponsor aims to investigate if JDQ443 will stop abnormal cell growth related to the marker KRAS G12C mutation in patients with NSCLC…

The influence of different diets on alectinib pharmacokinetics in NSCLC patients (the DIALECT study).

To investigate the effect of various dietary interventions and co-administration of subcutaneous semaglutide on the pharmacokinetics of alectinib in NSCLC patients.

Clinical Performance Study for PD-L1 IHC 22C3 pharmDx on Non-Squamous Non-Small Cell Lung Cancer Specimens.

This is a clinical performance study of PD-L1 IHC 22C3&nbsp;pharmDx on non-squamous non-small cell lung cancer&nbsp;specimens.&nbsp;PD-L1 IHC 22C3 pharmDx will be used to select non-squamous NSCLC patients eligible for the TROPION-Lung07…

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)

This study has been transitioned to CTIS with ID 2024-511793-71-00 check the CTIS register for the current data. Phase 1Primary Objective• To determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with…