GO29432 Phase III Study of MPDL3280A in Stage IV Squamous NSCLC
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF MPDL3280A (ANTI−PDL1 ANTIBODY) COMPARED WITH GEMCITABINE+ CISPLATIN OR CARBOPLATIN FOR PD-L1−SELECTED, CHEMOTHERAPY NAIVE PATIENTS WITH STAGE IV SQUAMOUS NON−SMALL CELL LUNG CANCER
IRAS ID
181752
Contact name
Yvonne Summers
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2014-003106-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 9 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.
Immunotherapeutic agents that modulate immune cell activity offer an alternative approach that could potentially improve the prognosis of patients. MPDL3280A is an antibody that affects the immune system by blocking the programmed death-ligand 1 (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, MPDL3280A may help the immune system stop or reverse the growth of tumours. MPDL3280A is currently being tested in multiple clinical trials and has shown demonstrated activity and was well tolerated in patients with advanced malignancies who failed standard-of-care therapies in a Phase Ia study.
The study purpose is to test the safety and efficacy of MPDL3280A compared with platinum-based therapies in PD-L1 selected chemotherapy-naïve patients with stage IV squamous NSCLC. Patients will be randomly assigned to receive open-label MPDL3280A (1200mg) every 21 days until loss of clinical benefit, toxicity or death or Gemcitabine+Cisplatin or Carboplatin (per investigator choice) every 21 days for 4 or 6 cycles by IV infusion (as per local standard of care) until disease progression, unacceptable toxicity or death.
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 400 participants will take part in the study, with approximately 15 to be randomised in the UK.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0197
Date of REC Opinion
14 Oct 2015
REC opinion
Further Information Favourable Opinion