Study to test safety/efficacy of CIT treatment in NSCLC patients
Research type
Research Study
Full title
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (MORPHEUS-LUNG)
IRAS ID
233362
Contact name
Farah Lim
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2017-001267-21
Duration of Study in the UK
3 years, 4 months, 4 days
Research summary
This is a Phase Ib/II, open-label, multicenter, randomised, umbrella study in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Despite improvements in the first-line treatment of patients with metastatic NSCLC that have resulted in longer survival times and reduced disease-related symptoms, significant unmet medical need exists in this patient population. Patients who experience progression during or following first-line treatment for metastatic NSCLC have an even more limited prognosis, with a median survival of approximately 8-9 months that negatively impact quality of life. Thus, there is a continuing need for more efficacious, better-tolerated treatments.
In this study thirteen treatment arms are available. Patients will be randomised into treatment arms based on eligibility criteria and the stage of the study. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population (e.g., with regard to prior anti-cancer treatment or biomarker status). Two cohorts will be enrolled in parallel in this study. Patients will be recruited in Cohort 1 or Cohort 2 based upon tumour PD-L1 expression, what previous treatments they have received and how they responded to those treatments.
A number of assessments will be performed, differing depending on which treatment arm and stage a patient is at during the study. Assessments may include physical examinations, blood samples, ECOG performance status review, opthalmologic examination, electrocardiograms, Multigated Acquisition (MUGA), Computed Tomography Scans (CT Scans), Positron emission tomography–computed tomography (PET-CT Scans), Echocardiography (ECHO), biopsies, and/or Magnetic Resonance Imagine Scans (MRI Scans). These assessments will help to determine if the study drugs are effective and safe.
The study will run at 2 centres in the UK and is sponsored by F. Hoffmann-La Roche Ltd.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0045
Date of REC Opinion
25 Jan 2018
REC opinion
Favourable Opinion