Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL – (COASTAL)

Inclusion Criteria:

Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan

Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:

FL Gr 1, Gr 2, or Gr 3a
MZL (splenic, nodal, or extra-nodal)
Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm
Adequate hematologic parameters at screening unless abnormal values are due to disease
Adequate renal and hepatic function
Adequate cardiac function based on ECG and LVEF assessments

Exclusion Criteria:

Histologically confirmed diagnosis of FL Gr 3b or transformed disease
Prior therapy with PI3K inhibitors
Ongoing or history of drug-induced pneumonitis
Known lymphomatous involvement of the central nervous system
Tested positive for or active viral infection with hepatitis B or C virus
Tested positive or active infection with human immunodeficiency virus
Tested positive, or active infection with human T-cell leukemia virus type 1
Any uncontrolled clinically significant illness
History of clinically significant cardiovascular abnormalities such as congestive heart failure
History of clinically significant gastrointestinal (GI) conditions
Females who are pregnant