WHO ICTRP trial
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in…
CTIS2023-507494-18-00 · EU Clinical Trials Information System · Recruiting
Key facts
| Trial ID | CTIS2023-507494-18-00 |
|---|---|
| Public title | A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases |
| Scientific title | Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements with and Without Central Nervous System Metastases - MO41552 |
| Primary sponsor | F. Hoffmann-La Roche AG |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No |
| Countries | India;Mexico;China;Thailand;Brazil;Lebanon;Jordan;Turkey;Russian Federation;Croatia;France;Greece;Italy;Romania;Spain;Sweden;Netherlands;Slovakia;Germany |
| Conditions | Non-small cell lung cancer with ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene rearrangements MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864;Therapeutic area… |
| Interventions | Product Name: XALKORI 250 mg hard capsules, Product Code:PRD3362138, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: XALKORI 250 mg hard capsules, Product Code:PRD3362133, Pharmaceutical Form… |
| Registration date | Jan 15, 2024 |
| Target size | 206 |
| Secondary IDs | 2019-003859-11 |
| Registry page | euclinicaltrials.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: