BO40336: Alectinib vs. Chemotherapy in ALK+ non-small cell lung cancer
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ALECTINIB VERSUS ADJUVANT PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH COMPLETELY RESECTED STAGE IB (TUMORS ≥4 CM) TO STAGE IIIA ANAPLASTIC LYMPHOMA KINASE−POSITIVE NON−SMALL CELL LUNG CANCER
IRAS ID
242862
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-004331-37
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CANC 36930, CRN Refernce Number
Duration of Study in the UK
8 years, 4 months, 29 days
Research summary
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related deaths worldwide. Survival rates tend to be low due to late diagnosis and few available effective treatments. Around 60% of patients are diagnosed with advanced (Stage IIIB) or metastatic (Stage IV) NSCLC, and approximately 40% with early-stage NSCLC (Stage IB to Stage IIIA). 5-year survival rates range from 1%–5% for advanced and metastatic disease, and 14%–70% for early-stage disease depending on the extent of disease at diagnosis and available treatment options.
For early-stage disease, tumour resection (surgery) is the preferred treatment however disease recurrence develops in up to 70% of patients. Adjuvant (post-surgery) platinum-based chemotherapy (standard-of-care) provides additional but limited benefit. Chemotherapy is associated with significant toxicity, low tolerance and poor treatment compliance.
4%–5% of NSCLC tumours are positive for the ‘ALK’ gene (i.e. ALK-positive (ALK+) NSCLC). Targeted treatments like ALK-inhibitors may provide clinical benefit and favourable tolerability compared with chemotherapy, however none are approved in the adjuvant setting.
A high unmet need remains for new therapies which provide greater clinical benefit and favourable safety profile than chemotherapy. Overall, alectinib (an ALK-inhibitor) is shown to have meaningful benefit and an acceptable safety profile in advanced or metastatic ALK+ NSCLC. Emerging data shows alectinib may be beneficial as adjuvant treatment.
This study will evaluate the effectiveness and safety of alectinib compared with platinum-based chemotherapy in patients with fully-resected Stage IB to Stage IIIA ALK+ NSCLC. Eligible participants will be classed by disease-stage and randomised to either:
• Experimental Treatment: Alectinib (600 mg twice daily) for 24 months + up to 5 years follow-up; or,
• Control Treatment: platinum-based chemotherapy every 21 days (a cycle) for 4 cycles + up to 5 years follow-up.255 patients will be enrolled globally (12 patients at 4 UK sites) over approximately 3 years.
Sponsor: F. Hoffmann-La Roche Ltd.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0408
Date of REC Opinion
12 Jul 2018
REC opinion
Further Information Favourable Opinion