Lorlatinib (PF-06463922) Open Label Lung Cancer Study
Research type
Research Study
Full 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
IRAS ID
217180
Contact name
Leonard James
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2016-003315-35
Duration of Study in the UK
6 years, 2 months, 2 days
Research summary
Around 3% of patients with non-small cell non squamous lung cancer harbour the ALK (Anaplastic Lymphoma Kinase) driver mutation. These patients are particularly responsive to a drug called Crizotinib, a first generation ALK/ROS/cMET inhibitor. However, on average their cancer will become resistant to Crizotiinb and progress in less than one year.
Lorlatinib (PF-06463922) is a next generation ALK inhibitor which has been shown to be more potent than Crizotinib in early phase studies. The purpose of this phase III study is to evaluate whether using Lorlatinib instead of Crizotinib (the current standard of care), as first line treatment in these patients, will delay the development of resistant disease and control their cancer for a longer period of time (as measured by their progression free survival).
Qualified patients (280) will be randomised across the globe in a 1:1 ratio, stratified according to their ethnic origin (Asian versus non Asian) and whether they have metastases in their brain, to receive either
Crizotinib, the current standard of care (Arm A) or Lorlatinib, the new unapproved investigational product (Arm B)
Both drugs are given in tablet form.
Once a treatment is assigned patients cannot change, unless they withdraw consent, and move onto the standard of care only. Consent will be requested for all procedures before proceeding. Each cycle will consist of 28 days, and study treatment may continue until confirmed disease progression or unacceptable toxicity, and as longs as the patient and doctor are comfortable to continue. Treatment product will be dispensed at the start of each cycle and patients will be trained to self medicate at home, and keep a patient diary.
Patients will visit the center periodically for follow up and to return unused IP and receive new a treatment batch, and to discuss how the treatment makes them feel, and if they are experiencing side effects.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0074
Date of REC Opinion
16 Mar 2017
REC opinion
Further Information Favourable Opinion