GO40241 - Phase III - Neoadjuvant Atezolizumab + Chemotherapy in NSCLC
Research type
Research Study
Full title
A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON−SMALL CELL LUNG CANCER
IRAS ID
239570
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-002857-12
Clinicaltrials.gov Identifier
CANC 35773, NIHR CRN Reference Number
Duration of Study in the UK
6 years, 10 months, 5 days
Research summary
Lung cancer remains the leading cause of cancer deaths worldwide and the most common cancer in men and women. Non−small cell lung cancer (NSCLC) – the main subtype – accounts for ~85% of all cases. Overall 5-year survival rate for advanced disease is 2%−4%. Factors affecting poor prognosis for survival include advanced stage of disease at initial diagnosis and metastatic disease.
In its early stages, NSCLC is treated surgically (resection) to ‘cure’ the disease. However, 30%−70% of patients undergoing resection develop disease recurrence and die from disease progression. Radiotherapy is no longer recommended as adjuvant therapy (i.e. after surgery) due to poor effects on long-term survival.
Platinum-based chemotherapy (e.g. cisplatin, carboplatin) is used as adjuvant therapy or neoadjuvant therapy (i.e. before surgery), to improve survival outcome compared with surgery alone.
Adjuvant platinum-based chemotherapy is now the standard-of-care for fully resected Stage II, IIIA, or select IIIB NSCLC. Cisplatin or carboplatin have been combined with nab-paclitaxel and pemetrexed to treat NSCLC.Neoadjuvant platinum-based chemotherapy is a widely-accepted alternative for Stage II, IIIA or select IIIB NSCLC, with survival benefits comparable to adjuvant chemotherapy.
Atezolizumab (cancer immunotherapy) is approved in the US and EU for patients with metastatic NSCLC who have disease progression during or after platinum-containing chemotherapy. Atezolizumab+platinum-based chemotherapy is generally well-tolerated and is being investigated in several ongoing studies.
This Phase III GO40241 study, sponsored by F. Hoffman La Roche, will investigate neoadjuvant atezolizumab+platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB NSCLC. Participants will receive 4 cycles of neoadjuvant therapy (atezolizumab/placebo+platinum-based chemotherapy), followed by surgical resection, then either, adjuvant treatment with atezolizumab (16 cycles/48 weeks) or best supportive care (BSC) for 48 weeks.
302 participants will be recruited globally over an estimated 18-months, and the study will last approximately 79 months. 3 UK sites will participate in this study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0133
Date of REC Opinion
27 Apr 2018
REC opinion
Further Information Favourable Opinion