WHO ICTRP trial

Study with investigational drug PF-06463922 and comparator crizotinib in…

EUCTR2016-003315-35-DK · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2016-003315-35-DK
Public title Study with investigational drug PF-06463922 and comparator crizotinib in patients with a specific type of advanced lung cancer
Scientific title A Phase 3, randomized, open-label study of lorlatinib (PF-06463922) monotherapy versus crizotinib monotherapy in the first-line treatment of patients with advanced ALK-positive non-small cell lung cancer
Primary sponsor Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Registry EU Clinical Trials Register
Recruitment status Not 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 United States;Hong Kong;Taiwan;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Czech…
Conditions Advanced ALK positive non small cell lung cancer MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts…
Interventions Product Name: PF-06463922 Product Code: PF-06463922 Pharmaceutical Form: Tablet INN or Proposed INN: PF-06463922 Other descriptive name: PF-06463922 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25…
Registration date May 24, 2017
Target size 280
Secondary IDs B7461006;118296;2016-003315-35-GB
Registry page clinicaltrialsregister.eu

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