PhaseIII Study-Atezolizumab with chemotherapy in Stage IV Non-Squamous
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI−PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN+PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN+PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS NON−SMALL CELL LUNG CANCER
IRAS ID
186322
Contact name
Simon Anthony Ball
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2015-003605-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Non-small cell lung cancer (NSCLC) is the most common subtype of lung cancer. Patients diagnosed with NSCLC have poor prognosis with overall 5-year survival rate for advanced disease is 2-4%. Platinum-based chemotherapy regimens remain the first-line treatment for most locally advanced and metastatic NSCLC without a genetic mutation despite their toxicities. Hence the need for novel therapies that deliver an improved therapeutic index.
Agents that modulate immune cell activity (often called ‘immunotherapies’) offer an alternative approach that may improve the prognosis of patients. Atezolizumab (MPDL3280A - study drug) is an antibody that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway is involved in decreasing the body’s immune response to fight cancer. By blocking the PD-L1 pathway, atezolizumab may help the immune system stop or reverse the growth of tumours. Atezolizumab is currently being tested in multiple clinical trials and has demonstrated activity and has been well tolerated in patients with advanced malignancies who failed standard of care therapies in Phase Ia & Phase II studies.
The purpose of this study is to test the safety and efficacy of atezolizumab in combination with carboplatin or cisplatin + pemetrexed compared with carboplatin or cisplatin + pemetrexed in patients who are chemotherapy-naïve who have stage IV non-squamous NSCLC. Patients will be randomly assigned to one of two treatments arms. Treatment will be separated into two phases, the induction phase and the maintenance phase.
Study procedures include: vital signs, physical examination, ECG, urine/blood samples for laboratory tests, tumour biopsy (if no previous samples are available), patient questionnaires and radiographic assessments to monitor the disease.
This study is being sponsored by F. Hoffmann-La-Roche. Approximately 680 participants (415 carboplatin & 265 cisplatin) will take part in the study, with
approximately 40 to be randomised in the UK.REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0161
Date of REC Opinion
29 Apr 2016
REC opinion
Further Information Favourable Opinion