IM power010: Phase 3 study of Atezolizumab in non-small lung cancer
Research type
Research Study
Full title
A phase III, open-label, randomized study to investigate the efficacy and safety of Atezolizumab (anti−pd-l1 antibody) compared with best supportive care following adjuvant cisplatin-based chemotherapy in pd-l1−selected patients with completely resected stage Ib−IIIa non−small cell lung cancer
IRAS ID
184930
Contact name
Joyce Thompson
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2014-003205-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117296, IND number
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Patients diagnosed with NSCLC have poor prognosis with an overall 5 year survival rate for advanced disease of approximately 2-4%. In its early stages, NSCLC can be treated surgically with curative intent. However, 30%−70% of patients undergoing surgical removal (resection) of their tumour develop recurrence and die as a result of their disease. Adjuvant chemotherapy is the standard of care in this setting, but a need remains for novel therapies that deliver improved safety and efficacy.
Atezolizumab 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 immune system’s response to fight cancer. By blocking the PDL1 pathway, atezolizumab may help the immune system stop or reverse the growth of tumours. Atezolizumab is currently being tested in multiple clinical trials. In a Phase IA study in patients with advanced malignancies who failed standard of care therapies, atezolizumab has demonstrated activity and was well tolerated.
The purpose of this open label study is to compare the efficacy and safety of atezolizumab versus best supporting care in patients with Stage IB−Stage IIIA NSCLC following resection. The study consists of an enrollment phase, during which patients will receive cisplastin-based chemotherapy and a randomised phase where patients from the enrollment phase will be randomly assigned to receive either atezolizumab or best supportive care.
Study procedures include: vital signs, physical examination, ECG, urine/blood samples for laboratory tests, tumour biopsy and radiographic assessments to monitor the disease.
This study is being sponsored by F. Hoffmann-La Roche. Approximately 845 patients are expected to be accrued in the enrollment phase.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0521
Date of REC Opinion
15 Jan 2016
REC opinion
Further Information Favourable Opinion