Alectinib in Combination With Bevacizumab in ALK Positive NSCLC
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
Lung cancer remains the most lethal malignancy in both sexes around the world. It is
estimated that lung cancer caused 234,030 deaths in the United States in 2016, accounting for
28% of all cancer-related deaths. In 2012 alone, a total of 6,697 deaths from lung cancer
were registered in Mexico; this number exceeds the death toll from other common solid
neoplasms (i.e., stomach, prostate, breast, and liver). In addition to its high incidence,
lung cancer patients face a dismal prognosis, with an overall 5-year survival ranging from
5-16%.
In the last two decades, the outlook for a subset of Non-small cell lung cancer (NSCLC)
patients has shifted. Novel approaches have been able to identify that a significant number
of patients present tumors with actionable mutations, opening the possibility of treatment
with targeted therapies, which have increased survival outcomes in these patients. A number
of specific therapies have been developed over the past decade, such as epidermal growth
factor receptor (EGFR) inhibitors or anaplastic lymphoma kinase (ALK) inhibitors.
Additionally, treatment options for patients with NSCLC with actionable mutations has
increased in the last two decades, with several third generation inhibitors available, which
have different efficacy and tolerability profiles, nonetheless, global 5-year survival rates
remain below 20%, which highlights the need to explore therapeutic combinations which might
derive in greater long-term survival for this patient subgroup. Although encouraging data has
been reported in terms of adding Bevacizumab to EGFR-TKIs, this scheme has not been explored
for patients who have ALK-rearranged NSCLC and who are candidates for ALK-inhibitors.
Currently, Alectinib has been shown to offer several advantages compared to first-generation
ALK-TKIs, including a stronger ALK-inhibition, better outcomes in patients with Central
Nervous System (CNS) involvement and longer duration of response. However, the addition of
Bevacizumab to therapy with Alectinib in treatment naïve or previously treated NSCLC patients
remains unexplored.
Based on this data and the need to continue searching for safe and effective therapeutic
options, a phase II, single arm trial assessing Alectinib in combination with Bevacizumab in
untreated and previously treated patients with Advanced or Metastatic Non-Squamous
ALK-rearranged NSCLC has been designed.